Physicians and Firearms: Finding a Duty to Talk to Patients About Guns [from Bill of Health]

In April, our Center for Health Policy and Law hosted a two-day conference entitled "Diseases of Despair: The Role of Policy and Law." Our friends at Harvard Law School's Petrie-Flom Center is now hosting a blog symposium from that conference on Bill of Health. 

The second piece is from our own Elisabeth J. Ryan.  For the full post, please visit Bill of Health. Additionally, a much longer version of this post will appear as an article in the forthcoming Winter edition of the Northeastern University Law Review.

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This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

Florida enacted a statute in 2011 entitled the “Firearms Owners’ Privacy Act,” which quickly became known nationwide as simply the “Docs v. Glocks” law.

This law essentially forbade doctors from asking their patients about gun ownership, recording information about guns in the home, and “unnecessarily harassing” patients for being gun owners. The penalty was potential medical license sanctions and a fine up to $10,000.

Championed by the NRA and the state of Florida as protecting Second Amendment rights, the law set off a nationwide debate about the free speech rights of physicians, the role the medical community plays in the fight against gun violence, and the rights of patients to keep the exercise of their Second Amendment rights private. Several Florida doctors challenged the law almost immediately, claiming that it infringed not only on their right to speak with patients, but on the patients’ rights to hear that speech. While the ensuing procedural history of Wollschlaeger v. Governor of Florida was complex to say the least, the full Eleventh Circuit Court of Appeals ultimately struck down most of the law as a violation of the First Amendment in 2017.

Though the ruling technically applies only within the Eleventh Circuit, the decision (which Florida wisely declined to appeal to the U.S. Supreme Court) had social and legal ramifications far beyond that region. The message was clear: physicians have a right to talk to their patients about firearms. The next logical step is to ask whether they actually have a duty to do so.

Please visit Bill of Health for the rest of the post!

Diseases of Despair: The Role of Policy and Law [from Bill of Health]

In April, our Center for Health Policy and Law hosted a two-day conference entitled "Diseases of Despair: The Role of Policy and Law." Our friends at Harvard Law School's Petrie-Flom Center is now hosting a blog symposium from that conference on Bill of Health. 

The first piece is from Professor Wendy E. Parmet and Jennifer Huer. The full original post can be found here.

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We are pleased to host this symposium featuring commentary from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series will be available here.

As a note, additional detailed analyses of issues discussed during the conference will be published in the 2019 Winter Issue of the Northeastern University Law Review.

After decades of improvement, overall life expectancy in the United States has decreased over the past two years. In a widely-read paper published in 2015, economists Anne Case and Angus Deaton found that pronounced increases in death rates among middle-aged non-Hispanic men and women were driving these declines.

“Diseases of Despair include substance use disorders, suicides and alcohol-related diseases.”

Case and Deaton linked this alarming trend to so-called “diseases of despair,” which include substance use disorders, suicides, and alcohol-related diseases. Their report went on to highlight two other important points: First, the U.S. stands alone as the only industrialized nation facing this anomaly. Second, the increase in mortality rates was far higher for middle-aged non-Hispanic whites with less education than for their college-educated counterparts.

In an updated report issued in 2017, Case and Deaton noted that this reduction in life expectancy, especially due to deaths related to diseases of despair, was not confined to particular geographic regions within the U.S. Rather, the trends have become widespread, though there is variability in mortality rate increases across regions. Further, although the declines are specific to whites, overall mortality rates for other populations, such as non-Hispanic blacks, remain higher than mortality rates for non-Hispanic whites.

The overall decline in life expectancy in the U.S. and the concomitant rise in diseases of despair, especially the dramatic increase in deaths related to opioid overdoses and suicides, raise a plethora of questions.

To explore the causes of the phenomenon, and discuss potential solutions, Northeastern University’s Center for Health Policy & Law held a conference in April 2018, titled “Diseases of Despair: The Role of Policy and Law,” which brought together researchers, policymakers, practitioners, and advocates from across disciplines. The conference focused on suicide, opioid and substance use, and violence, and emphasized the role of law in both causing and addressing these problems.

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For the rest of the piece, please visit the original at Bill of Health!

Behind Schedule -- Reconciling Federal and State Marijuana Policy [from The New England Journal of Medicine]

This piece originally appeared in The New England Journal of Medicine. 

By Rebecca L. Haffajee, Robert J. MacCoun, and Michelle M. Mello

The long-standing chasm between federal and state marijuana policy recently widened when U.S. Attorney General Jeff Sessions rescinded Obama-era guidance indicating that the Justice Department would not make it a priority to prosecute federal marijuana crimes in states where the activities are legal. At present, a budgetary amendment is the only legal barrier to Justice Department enforcement of the Controlled Substances Act (CSA) against users and sellers of medical marijuana in the 30 states that have legalized it. Nothing prevents federal prosecution of recreational marijuana activities in jurisdictions where they are legal. However, spurred by Sessions’s policy, Senator Elizabeth Warren (D-MA) introduced a bipartisan bill in June 2018 (S.3032) that would exempt most marijuana-related activities from CSA application when they’re allowed under state or tribal law — legislation that President Donald Trump says he will support. As the marijuana-policy terrain shifts, it’s important to consider the potential public health benefits of closing the federal–state divide.

Controversy over marijuana policy originates from the 1970 federal decision to classify marijuana as a Schedule I substance under the CSA. Schedule I drugs are deemed to have high potential for abuse and no accepted medical use. Crimes involving such drugs can result in penalties of thousands to millions of dollars and substantial prison time. Marijuana’s Schedule I classification has been repeatedly challenged in all branches of the federal government (see timeline), but although synthesized versions of some marijuana components, including the psychoactive compound tetrahydrocannabinol (THC), have been rescheduled and approved by the Food and Drug Administration (FDA), the plant as a whole has not. The FDA did recently approve a plant-based product, cannabidiol (CBD; Epidiolex), for the treatment of certain seizures in children.1 The Drug Enforcement Administration is expected to reschedule CBD so that Epidiolex can be sold legally.

Although the Obama administration did not support rescheduling of marijuana, it signaled in a series of Justice Department memos that it would ease federal marijuana-crime enforcement in some circumstances. This guidance culminated in the 2013 Cole Memorandum, which deprioritized marijuana prosecutions in states where use was legal, indicating that states could proceed with carefully regulating and taxing marijuana. The Rohrabacher–Blumenauer Amendment (previously the Rohrabacher–Farr Amendment), adopted by Congress the following year and currently renewed through September 2018, went further, prohibiting the use of federal funds to prosecute medical marijuana activities.

Encouraged by these developments, states have moved toward marijuana legalization, which more than 6 in 10 Americans now favor, according to a survey by the Pew Research Center. Starting with California in 1996, more than half the states have legalized medical marijuana, and at least three are currently considering doing so. This year, at least six more states are poised to follow the nine states and District of Columbia that have legalized recreational marijuana.

As state legal restrictions have eased and evidence concerning marijuana’s medical benefits has accumulated, marijuana use has increased: about 9% of Americans 12 years of age or older used marijuana in 2016, according to the National Survey on Drug Use and Health. Marijuana sales in states where they are legal topped $8 billion in 2017 and are projected to grow to $24 billion by 2025.2 State revenues from taxes and permits — totaling $745 million in 2017 and used for budget shortfalls, schools, public heath, and law-enforcement programs — are expected to reach $4.3 billion in 2020.2 In short, state marijuana legalization and industry growth show no signs of slowing.

Sessions’s about-face in January introduced new uncertainty. Although marijuana taxes typically account for at most 1% of state general-fund revenues, states’ reliance on this money may increase as sales grow. Marijuana businesses face difficulty obtaining federally regulated credit and other banking services because of their precarious legal status.3

Such effects could jeopardize the continuity of the medical marijuana supply. In some states, dispensaries are licensed to supply to both recreational and medical users, so action against them or their suppliers shrinks access for all. For patients using marijuana in lieu of potentially riskier alternatives such as opioids, supply reductions could worsen health outcomes. Furthermore, marijuana’s Schedule I status is a known hindrance to conducting the research required to secure FDA approval of medical marijuana products; federal funding for such research has been meager, and the federal government has a monopoly on supplying marijuana for clinical trials.

Another threat to medical users is the possibility that Congress will not renew the Rohrabacher–Blumenauer Amendment, leaving prescribers, dispensers, and patients vulnerable to federal criminal enforcement. Ultimately, individual U.S. attorneys’ offices will have to decide how to prioritize prosecution of federal marijuana offenses in light of competing demands on their resources — which will exacerbate the unpredictability of marijuana markets. U.S. attorneys have considerable discretion, and though the social climate for prosecuting medical users in particular is not favorable, there are no longer any guarantees.

In addition, the absence of a sensible, stable federal marijuana policy affects the safety of marijuana products and physicians’ comfort in recommending or prescribing them. Although the FDA has an approval track for botanicals, only one purified plant-based marijuana product is currently regulated by the FDA.1 Inconsistency in marijuana regulation from state to state can allow inappropriate marketing, formulation, and packaging practices to persist — making THC content across samples unpredictable, for instance, or permitting marketing of edibles that appeal to children.4 Without FDA approval, a lack of information about efficacy, dosing, adverse effects, and availability of marijuana products deters providers from recommending them.

The present state of conflicting laws seems unstable and suboptimal for rational drug control. Federal regulation that accommodates and reinforces state medical marijuana regulatory regimes would result in a safer, more reliable, more accessible supply of marijuana products. Congress, because it answers to the people and represents the states, appears the most likely branch to move on marijuana policy; it could even be encouraged to act by Canada’s recent legalization of recreational marijuana. Federal courts are increasingly hearing challenges to marijuana’s Schedule I status but have so far been unwilling to deem Congress’s scheduling determination irrational and therefore unconstitutional.

In Congress, rescheduling marijuana by amending the CSA is one attractive option. The executive branch, too, can reschedule CSA substances,3 but the mechanisms are time consuming and unlikely to attract interest within the current administration. Because considerable evidence now supports marijuana’s therapeutic benefits in reducing chronic pain, nausea, and vomiting in patients with cancer, as well as multiple sclerosis–related muscle spasms,5 there is a compelling argument that marijuana is more appropriately designated as a Schedule II or Schedule III drug. Rescheduling would facilitate further study of products for FDA approval, but would not automatically change the severity of penalties for marijuana crimes or alter international treaty obligations, enshrined in the CSA, to ensure that all psychoactive substances are used only for legitimate medical and scientific purposes.3

Congress could also remove marijuana from the CSA schedules altogether. This dramatic action could be coupled with legislation authorizing FDA oversight of marijuana products. Whether marijuana’s psychoactive effects preclude this move away from regulation as a controlled substance would provoke considerable debate. Subjecting marijuana products to FDA approval would hinder access initially but ultimately foster a robust system for regulation and research. FDA oversight of marketing would also improve product safety and consistent promotion across states.3

The Warren legislation represents a third option designed to respect states’ rights — codifying the approach articulated in the Cole Memorandum by amending the CSA to exempt marijuana activities that are lawful in the jurisdiction where they occur. This solution would be more permanent than attorney-general guidance or agreements between states and the attorney general regarding enforcement, which shift with the political winds, and would therefore promote stability for medical users and suppliers. But it would not facilitate research into marijuana harms and benefits, bring products within the FDA’s purview to ensure safety and efficacy, alleviate interstate health risks, or address potential conflicts with international treaty obligations.

We think this third option, which addresses some pressing conflict-of-law concerns such as unpredictable criminal enforcement, is preferable to the current blurred vision of the future of marijuana policy. Ultimately, a more comprehensive federal regime that perhaps resembles Canada’s recent legalization of recreational marijuana could affirmatively promote health and safety through research and regulation.

A Heartbreaking Tale Underscores Why Massachusetts Corrections Facilities Need to Offer Medication Assisted Treatment for Opioid Use Disorder

By Elisabeth J. Ryan

Last month, I wrote about Massachusetts criminal justice reform and lamented that a clause allowing medication assisted therapy in correctional settings had been removed from the final bill:

One of the earlier versions of this reform bill contained a provision that would have allowed people with opioid use disorders to have access to medication assisted treatments(MAT) while in prison. That would have been a major public health triumph, as illustrated by its success in Rhode Island prisons. MAT remains the gold standard of care for opioid use disorders; studies show that people on MAT are more than twice as likely to remain opioid-free. Incarcerated individuals have much higher than usual rates of substance use disorders and are 129 times more likely to die of an overdose within two weeks of release from prison, compared to the general population.  The Rhode Island program that gave its incarcerated population access to MAT not only resulted in much higher rates of adherence to treatment after release, but also corresponded with a 12% reduction in overdose deaths statewide. Unfortunately for Massachusetts, which has one of the highest overdose death rates in the country, the provision that would have provided MAT is prisons did not make it to the final criminal justice bill.

According to the Boston Globe, however, a change in the policy is "gaining momentum - but slowly." Twenty-six groups continue to advocate for medication assisted treatment to be required in Massachusetts jails and prisons, emphasizing that, "The science and research on this is clear. To wait any longer to do this is just going to result in needles loss of life," according to the chief executive of the Association for Behavioral Health Care. The Globe story features the heartbreaking tale of a mother who had struggled with her own substance use disorder and then lost her 27-year-old son to an overdose the same day that he was released from pretrial custody. Stephen Gonzalez had been on prescribed methadone for five years prior to being arrested. The Suffolk County jail, per policy, did not provide him with the methadone while holding him in custody. His brutal withdrawal sent him into "unbearable pain." With a diminished tolerance, he sought heroin almost as soon as he got out to attend his stepfather's funeral. The overdose killed him, leaving his mother "to bury her husband and her son in the same week."

The barrier to providing medication assisted therapy in Massachusetts correctional settings is not just the lack of a law enabling it, however. The Department of Corrections and most of the sheriff's departments actively object to having methadone and buprenorphine available to inmates "because the drugs are opioids that can be diverted for illicit use." Only the two houses of correction in Franklin and Hampden counties in Western Massachusetts offer medication-assisted treatment.

The US Department of Justice is also investigating whether denying inmates access to legitimately prescribed medication assisted therapy while incarcerated violates the Americans with Disabilities Act.

Medicare is Not Going Broke [from philly.com]

By Robert I. Field

Have you heard the news? Medicare will run out of money in just four years. Can the program survive?

Four years is the time until the Trust Fund that provides financial support for Medicare will become insolvent – that is, according to a prediction that the Fund’s Trustees made in 1997. Then in 1998, they upped the timeframe to ten years and in 1999 to 16. They shrank it back to 12 years in 2006 and to eight in 2009.

The Trustees first projected an insolvency date for the Trust Fund in 1970, when they predicted that it was just two years away. Since then, the timeframe has varied wildly, reaching a high of 28 years under projections made in 2001 and 2002.

This year, the projection is for eight years, falling from 12 a year ago. That has led to dire predictions that Medicare as we know it is unsustainable. But after almost 50 years of fluctuating projections, the program has not gone under yet – and it is not likely to do so anytime soon.

The Medicare Trust Fund contains the proceeds of the payroll tax that all working Americans pay. It supports the cost of Part A of the program, which covers hospital care. It has no role in supporting Part B, which covers physician services, and Part D, which covers prescription drugs. While there is a separate trust fund for Part B, it is continually replenished with general tax revenue, so it can never become insolvent.

Even were the Trust Fund to become insolvent, Medicare is still projected to have enough money to pay 91% of claims. The shortfall could be remedied in a number of ways, like raising the payroll tax or reducing provider payment rates. Medicare would not be broke, and hospital coverage would continue.

And as past projections demonstrate, predicted dates for insolvency do not mean that it is inevitable. The projections are the Trustees’ best guess as to the date on which the Trust Fund will run out of funds based on current trends in medical spending and tax revenue. Those factors change every year, as the past gyrations in insolvency projections make clear.

This year’s tighter timeframe primarily reflects factors that would be easy to change – the Trump administration’s health care policies as implemented by Congress. Those policies weakened the Affordable Care Act, which had significantly strengthened the Trust Fund’s finances. The year after the ACA took effect, the insolvency timeframe shot up from eight years to 19. In particular, Congress’s repeal of the ACA’s individual insurance mandate set to take effect in 2019 will increase the number of uninsured, forcing Medicare to raise hospital payments to account for their care. The ACA also established an independent advisory board to cut costs, which Congress also repealed.

So, if you find the shorter Medicare timeframe concerning, the main culprit is clear. It is not the structure of the program or the ACA. It is the Trump administration’s policies, which are undermining the financial stability of much of our health care system.

Certainly, Medicare faces other long-term financial challenges as medical costs continue to rise and the number of beneficiaries grows. Policies to address those concerns are urgently needed.  But the most recent Trust Fund financial projection is a diversion from those more serious issues. The Trust Fund could be as solid as ever, if Congress were to put the ACA back on track.

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Robert I. Field, JD, MPH, PhD, is professor of law and public health at Drexel University and is the founder and editor of the Health Cents blog.

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This blog post first appeared in the Health Cents blog of Philly.com.

Massachusetts Denies the First "Compassionate Release" Application

By Elisabeth J. Ryan

In May, I wrote here about the new "compassionate release" program in Massachusetts that allows "incarcerated individuals diagnosed with a terminal illness - defined as an incurable condition that will likely cause death within 18 months - or those with 'permanent incapacitation' to request medical release before the end of their sentences. Ultimately, the decision is left to the commissioner of corrections or to the appropriate sheriff, who determines whether 'the prisoner will live and remain at liberty without violating the law and that the release will not be incompatible with the welfare of society.'" I also noted that, "How those in power will interpret that clause remains to be seen."  We now know that the first applicant has been denied.

Alexander Phillips is 31 years old and has served 12 years of an 18-20 year sentence for manslaughter after stabbing his former classmate in a fight. He has been a model inmate with a clean disciplinary record and has even earned his college degree from Boston University. He also has metastatic pancreatic and colon cancer that has spread throughout his body and he will likely not live for longer than one year. His mother is an oncology nurse who would care for him at home and would even ensure he had private health insurance. He can only walk about 25 feet at a time and sleeps most of the day.

Yet Massachusetts Department of Corrections commissioner Thomas Turco ruled that his release would be "incompatible with public safety and the welfare of society" because he is not "incapacitated enough." He cited Phillips's ability to walk up stairs, shower on his own, and get in and out of the vehicle taking him to chemotherapy appointments. Perhaps most telling, however, is that the family of the man Phillips killed does not want him released. While that is not supposed to be a dispositive factor, Alexander Phillips represents exactly the type of person that “compassionate release” was intended to apply to. To deny his release strongly indicates that those in power will likely continue to interpret the new law very, very narrowly.

The latest strategy to undermine Obamacare: challenge the constitutionality of a mandate that doesn’t exist [from Philly.com]

By Robert I. Field

Can a law be unconstitutional if it doesn’t exist? That may sound like an abstract riddle, like the proverbial tree falling in a forest, but it is central to a lawsuit challenging the constitutionality of the Affordable Care Act. The suit, brought by 20 Republican attorneys general, seeks to have the entire law thrown out, and the Trump administration recently announced its support.

The challengers’ argument goes like this. In 2012, the Supreme Court upheld the ACA’s mandate requiring all Americans to maintain health insurance or pay a penalty. The Court characterized the penalty as a tax, but one that is waived for the those who have coverage. Under this reasoning, the mandate is a tax penalty that comes under Congress’s broad power over taxation.

In the huge tax bill enacted late last year, the amount of the penalty was reduced to zero starting in 2019. The challengers assert that since no amount will be assessed for going without insurance, the mandate can no longer be characterized as a tax, thereby eliminating its constitutional underpinning.

They claim this invalidates all of the ACA, even provisions that have nothing to do with the mandate. The Trump administration’s position doesn’t go quite this far. It only wants the consumer protections for sick and injured insurance buyers to be eliminated.

This argument amounts to nonsense. With the penalty reduced to zero, the mandate no longer exists. The law contains no other penalty for choosing to be uninsured. It doesn’t matter whether you call the mandate a tax or anything else, as of 2019, it will no longer be in force. By what stretch of logic can a law that that is not in effect be considered unconstitutional?

The argument makes even less sense, if that is possible, when you consider that Congress’s power to re-impose the penalty in the future remains on the books. There is ample precedent for a tax to be suspended and then re-imposed. If Congress were to resurrect the penalty at some point, would the mandate become constitutional again? Or is it only unconstitutional when it isn’t in effect?

Even if the challengers could overcome this void of logic, they would face a second one in their request to have the entire law invalidated. They argue that the mandate can’t be severed from the rest of a law, so if it is declared unconstitutional, everything must go.

The guiding legal principle when a court strikes down part of a law is to look to Congress’s intent concerning the other parts. Congress did not declare its intent in the text of the ACA, but the intent of its recent actions is crystal clear. A few months before repealing the mandate penalty, it defeated a bill to repeal all of the ACA. If it had intended that the end of mandate would eliminate the law’s other provisions, it would not have voted to keep them.

It would be hard to imagine a more frivolous lawsuit. Yet the Trump administration has taken the highly unusual step of siding with the challengers and refusing to defend it. That role will be filled by 17 Democratic attorneys general.

With such a flimsy legal claim, why would the Trump administration pick up the challengers’ cause? The reason most likely has less to do with legal reasoning than with finding a new opportunity to sabotage Obamacare by disrupting the insurance marketplaces.

Regardless of which way the trial judge rules, an appeal is virtually certain. The case could well go all the way to the Supreme Court, a process that could take years. In the meantime, the litigation will inject an added element of uncertainty for insurers that participate in the marketplaces. That uncertainty, coupled with other Trump administration actions, like permitting the sale of barebones policies outside the marketplaces, could lead some of them to impose additional price hikes or to withdraw from the market altogether. It seems more than coincidental that the administration’s announcement came just as insurers are reaching decisions on prices and participation for next year.

By the time the case is finally resolved, it will have cost millions of dollars in legal expenses, not to mention additional millions that consumers will have to pay in higher prices for insurance. That money would be much better spent expanding coverage for sick patients than litigating a frivolous claim that seeks to take away their health care, instead.

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Robert I. Field, JD, MPH, PhD, is professor of law and public health at Drexel University and is the founder and editor of the Health Cents blog.

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This blog post first appeared in the Health Cents blog of Philly.com.

SJC Rules in Correa v. Schoeck: Pharmacies Have a (Limited) Duty to Notify Physicians About the Need for Prior Authorization

By Elisabeth J. Ryan

Back in January of this year, the Center for Health Policy and Law (of which PHLW is a part) signed onto an amicus brief in support of the appellant-plaintiff in the Massachusetts case of Correa v. Schoeck. On June 7, the SJC ruled in the plaintiff's favor, reversing the lower court's order of summary judgment for the defendant pharmacy.  The court held that a pharmacy has a "limited legal duty to take reasonable steps to notify both the patient and her prescribing physician of the need for prior authorization each time [she] tried to fill her prescription." 

The facts, as we said in our previous post on the case, were as follows: "Yarushka Correa was 19-year-old young woman who had recently been diagnosed with epilepsy after suffering a grand mal seizure.  Doctors placed her on Topamax, which effectively controlled her seizures.  However, her insurance company required that physicians obtain prior authorization before prescribing Topamax. Obtaining such authorization is a relatively routine paperwork process, yet it was never completed in this case. As a result, Walgreens would not dispense the medication and Yarushka was unable to fill her prescription for three months, despite going to Walgreens five times in an attempt to do so. In the normal course of business, and as promised to Yarushka and her mother, pharmacy employees contact the physician to notify of the need for prior authorization. No one at the pharmacy ever did that. Without her medication, Yarushka died after a grand mal seizure."

Notably, however, the court limited the duty to just one instance of notification per prescription fill attempt. It stated that "the pharmacy was not required to follow up on its own or ensure that the prescribing physician in fact received the notice or completed the prior authorization form."

The lawyer for the plaintiff (the late Yarushka's mother) stated that the SJC is the first court in the country to hold that a pharmacy has this duty to notify a doctor about needing authorization. The case will now proceed to trial (or settlement negotiations) on the wrongful death claim. 

Motivated by increasing numbers of "deaths of despair," the AMA adopts new policies aimed at reducing gun violence

By Jennifer Lea Huer

Earlier this week the American Medical Association (AMA) House of Delegates held their annual meeting in Chicago, Illinois, during which delegates voted to adopt multiple policies related to firearms and gun violence. Some of these policies reinforce and enhance policy positions the AMA has supported for years, while other policies offer specific recommendations for legislation that is currently under consideration at the state and federal levels.

Specifically, as posted on the AMA website, the list of new policies adopted include:

• Advocating for schools as gun-free zones

• Calling for ban on sale of assault-type weapons, high-capacity magazines

• Expanding domestic violence restraining orders to include dating partners

• Removing firearms from high-risk individuals

• Supporting increase in legal age of purchasing ammunition and firearms from 18 to 21

• Opposing federal legislation permitting “concealed carry reciprocity” across state lines; and

• Supporting gun buyback programs in order to reduce the number of circulating, unwanted firearms.

In support of its adoption of the gun-related policies listed above, the AMA pointed to increases in rates of suicide and firearm violence that the US is currently experiencing, part of the so-called “deaths of despair” highlighted by economists Anne Case and Angus Deaton in their 2015 and 2017 reports on the topic. Case and Deaton found that mortality rates for middle-aged non-Hispanic white men and women have been on the rise for years, and that these trends were so pronounced that they affected the overall mortality rate of the US population.

Similarly, the Centers for Disease Control and Prevention (CDC) released a report on June 7, 2018 confirming US suicide rates have increased dramatically (25%) over the past several years. The report showed that 49 states saw an increase in suicide rates (Nevada was the exception, though it still has one of the higher rates in the US) across all age and gender groups. This last point is particularly alarming, because though men have historically higher suicide rates than women, recent data indicates that women are also dying by suicide at significantly higher rates.

With nearly 45,000 Americans dying by suicide in 2016 alone, it is among the leading death of despair. While the CDC’s June 7th report does not does offer a deep dive into the causes behind the increased suicide rates, the report concludes with a strong recommendation for a coordinated public health approach to prevention activities and related research to better understand and address the factors contributing to these trends. At its annual conference, Diseases of Despair: The Role of Policy and Law, the Center for Health Policy and Law at Northeastern University School of Law also discussed the importance of rooting any meaningful, evidence-based, interdisciplinary approach within a public health framework. Conference discussions also emphasized the need to create stronger collaborations with community-based organizations that have ties in and trust with the communities they serve.

More research is needed to fully uncover and appreciate the causes behind these startling trends and to develop appropriate interventions. There is some evidence to suggest that stricter gun control laws may impact gun violence and suicide rates. Some physicians have argued that they have a role in prevention efforts. Legal and policy experts, as well as physicians, are still discussing the importance of the Wollschlaeger case and its effect on a physician’s ability to ask patients about the risks they face due to firearm safety in the home. Physicians not only have a role in prevention efforts, but they also see first-hand the horrific and tragic outcomes of firearm violence and suicide. Adoption of such a robust set of policy recommendations sends a clear and unified message that the AMA intends to continue to advocate for its patients and articulate the ways in which its physician members and the health care system can play a role in prevention efforts. It will be interesting to see if, and how, the AMA partners with public health and other experts to achieve its goal.

“Right-to-try” Means Right to Be Harmed by Unproven Treatments (from Philly.com)

By Robert I. Field

Imagine that you have a life-threatening disease and have run out of available treatments. You discover that there is a promising new medication that might work, but it is still undergoing testing. Would you want the right to try it?

If so, you’re in luck, because you have that right, and it has existed since the 1980s under a program known as compassionate use. To exercise it, your physician certifies that there is no comparable alternative and then requests approval from the Food and Drug Administration. The FDA implemented a streamlined review process in 2016 and approves more than 99 percent of those requests, usually within four days. If you take the medication, the agency keeps track of any adverse effects to protect you and others who might take the drug.

Despite the program’s success, a movement has grown over the past several years to cut the FDA out of the process.  Almost 40 states have passed “right-to-try” laws that allow patients to request experimental drugs directly from manufacturers. However, federal drug safety legislation preempts these laws, so they have had little practical effect.

In response, Congress, with strong support from President Trump, recently passed a federal right-to-try law that allows patients with a life-threatening disease or condition to request an experimental drug directly from the manufacturer without first going through the FDA.

What would the new federal law do for patients with terminal conditions? Absolutely nothing. In fact, it could cause them serious harm.

The law would allow patients to request drugs that have passed the first of three phases of clinical testing. That phase looks for safety concerns in a handful of subjects, sometimes as few as a dozen. It does not include any consideration of a drug’s effectiveness. More than two-thirds of drugs that pass phase one fail in the second phase, which does look at effectiveness, and more fail in the third. The chance that a drug will be shown safe and effective enough for use in actual medical practice after passing only phase one is less than one in six.

Many drugs that fail the testing process turn out to be not just ineffective but also dangerous. Some can make the underlying condition worse. The right-to-try law’s end-run around the FDA makes it difficult for the agency to monitor those risks. And it removes the patient’s physician from the equation, eliminating the traditional front-line of patient protection. What’s more, manufacturers are shielded from liability for most adverse effects.

Even after a request is made, a manufacturer is not required to supply the drug. In fact, it may have little interest in doing so. Right-to-try requests can pose a significant administrative burden and a distraction from the more pressing job of completing clinical trials as quickly and effectively as possible. Right-to-try requests could also siphon away the limited supply of experimental drugs that are needed for those trials. Manufacturers are also free to charge for the drugs at a price that may be unaffordable and that is not covered by insurance.

These concerns are why the law is opposed by 100 patient advocacy organizations, including the American Cancer Society, and numerous medical organizations. The main pharmaceutical industry association, the Pharmaceutical Research and Manufacturers of America, has expressed concern that eliminating FDA oversight of right-to-try requests could jeopardize patient safety. Even Scott Gottlieb, the Trump-appointed head of the FDA, has expressed strong skepticism.

Who supports the federal “right-to-try” law? Its main proponent is the libertarian Goldwater Foundation, which opposes most forms of government health and safety protection. It sees the law as a first step in a broader campaign to limit the FDA’s authority to protect the public.

It would be nice to live in a world in which oversight of health and safety by a government regulator is not needed for drugs and other medical interventions. Unfortunately, bitter experience over several decades with dangerous drugs and treatments has shown that we do not live in that world and are not likely to anytime soon. FDA regulation to prevent a repeat of those disasters has saved countless lives and prevented untold suffering.

The new “right-to-try” law threatens serious harm to vulnerable patients. And it cruelly encourages false hope in unproven treatments. Patient lives should be too important to let Ideology play around with.

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Robert I. Field, JD, MPH, PhD, is professor of law and public health at Drexel University and is the founder and editor of the Health Cents blog.

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This blog post first appeared in the Health Cents blog of Philly.com.