Will Public Health Litigation Help to Solve the Opioid Crisis?
Minor Access to Prophylaxes in Massachusetts: STI Consent, the Mature Minor Rule, and the Definition of "Treatment"
by Rebecca Haffajee
In this week’s issue of New England Journal of Medicine, Michelle Mello and I write about drug company liability for the opioid crisis. We analyze the history of litigation efforts against opioid manufacturers and distributors to hold these parties responsible, at least in part, for the epidemic. Early litigation brought by individuals harmed by prescription opioids against drug companies was minimally effective: most cases were dismissed early on and few settled. But these personal injury suits faced formidable company defenses -- such as that opioids were FDA-approved substances and that there were intervening causes (i.e., individuals not using the drugs as prescribed and doctors over-prescribing opioids) that contributed to the harm. However, in more recent years, mounting litigation lodged by governments may hold greater promise to succeed and reduce public health opioid-related harms, either through wins, settlements, or spillover effects. But let's be clear: litigation will not be a silver bullet to solving the crisis and shouldn't substitute for other public health-oriented policies and interventions. But lawsuits just might do some good here.
Read more in our Perspective, entitled "Drug Companies' Liability for the Opioid Epidemic."
Could repealing net neutrality be bad for our health? [From Health Cents, philly.com]
By Jason Potter
The Massachusetts Joint Committee on Public Health is currently considering House and Senate bills to amend the Commonwealth’s emergency consent statute (Section 12F), which allows certain minors to self-consent to general medical care, and allows all minors to self-consent STI diagnosis and treatment. The bills would add the term “prevention” to the Commonwealth’s STI consent statute, thus allowing minors in Massachusetts to consent to STI diagnosis, treatment, and preventive care. Known as the “PrEP Bill,” S.1186 and H.3249 are sponsored by Senator Julian Cyr and Representative Jack Lewis, respectively. The senators are seeking to expand the language of the portion of Section 12F pertaining to STI-related care so minors may consent to HIV Pre-Exposure Prophylaxis (PrEP) and the human papillomavirus (HPV) vaccine. In my 2016 article PrEP and Our Youth: Implications in Law & Policy, I proposed this very change. On June 27, 2017, I testified before the Joint Committee in support of the PrEP Bill.
"Benefits, Limitations, and Value of Abuse-Deterrent Opioids" in JAMA Internal Medicine
The following post, from George Consortium member Robert I. Field, was originally published in Health Cents on philly.com.
By Robert I. Field
Repealing net neutrality could be bad for American health care.
The Federal Communications Commission plans to vote this week on a proposal to repeal Obama-era rules that require Internet Services Providers, companies that connect your computer to the Internet like Comcast and Verizon, to treat all websites equally. The rules prohibit ISPs from speeding up or slowing down traffic to a site for financial or other reasons.
Why is Congress not prioritizing health care for children and other vulnerable populations?
Two members of our team - Dr. Gregory Curfman and Professor Leo Beletsky - and friend of PHLW Ameet Sarpatwari have an important new piece out in JAMA Internal Medicine entitled "Benefits, Limitations, and Value of Abuse Deterrent Opioids." "Abuse deterrent opioids" are formulations of the drugs meant to be tamper-resistant, "intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding." Looking at the Institute for Clinical and Economic Review report on Abuse-Deterrent Formulations of Opioids: Effectiveness and Value and adding independent analysis, the authors found that the selective use of abuse deterrent opioids may mitigate opioid abuse and diversion. However, the use may also promote switching to more dangerous opioids (like heroin). Finally, they found no evidence that abuse deterrent opioid use reduces overdose deaths.
Read the entire article here.
Of Mosquitoes and “Moral Convictions”: How Rolling Back the Affordable Care Act’s Contraceptive Mandate Jeopardizes Women’s and Children’s Health
By Jennifer Lea Huer
Back in September of this year, Congress was faced with the decision of whether or not to renew funding for both the Children’s Health Insurance Program (CHIP) and the Community Health Center Fund. Both sources of funding expired on October 1, 2017. As of the date of this post, 68 days have passed since Congress failed to renew funding for these crucial programs. Much has been written about the imminent need to reauthorize CHIP funding; states are already warning their residents that funding is running low and decisions about cutting coverage may soon follow. In addition to the estimated 9 million children in danger of losing coverage if CHIP funding is not renewed, recent studies estimate that millions more people could lose access to care if Congress does not take concrete steps to reauthorize funding for community health centers.
Briefly: Some Interesting Public Health Law Moves in Massachusetts
By Linda C. Fentiman
December 5 is the deadline to submit comments on the Trump Administration's recent action to gut the Affordable Care Act’s contraceptive mandate, which requires employer-sponsored health plans to ensure women's access to free, effective contraception. This decision, announced in October in two Interim Final Rules, threatens serious harm to American children, because of the risk that women who lack access to contraception will become pregnant, contract Zika, and unwittingly transmit the virus to their developing fetus. Since 2015, as an exponentially expanding Zika epidemic swept across Latin America, the United States, and its territories, thousands of children around the globe have been born with microcephaly. On the U.S. mainland alone, almost 100 children have been diagnosed with microcephaly or other Zika-associated birth defects. In Florida, the Department of Health has recently reported a new, sexually transmitted, case of Zika in Miami-Dade County. In 2017 alone, 225 cases of Zika infection were confirmed in Florida; 119 are pregnant women, and three infants have been born with congenital Zika syndrome. New York City, more than 400 pregnant women have been diagnosed with Zika since January 2016 and at least 20 infants have been born with microcephaly or other Zika-associated birth defects.
GOP Tax Bill Would Inflict Real Pain on Nonprofit Hospitals [From Philly.com]
As you enjoy a very nutritious helping or two of Thanksgiving dinner this week, here's some interesting happenings in Massachusetts public health law for you to chew on (haaa).
By Elisabeth J. Ryan
This week, the Commonwealth of Massachusetts became the first state in the nation to ensure that most health insurance plans cover birth control without cost-sharing to patients. Technically, this provision already exists federally in the still-good-law Affordable Care Act. However, in October, the federal government issued rules to roll back that requirement by allowing any employer to avoid such coverage by invoking religious or moral objections to contraception. The Massachusetts law still contains religious exceptions, including for churches and "qualified church-controlled organizations" as employers; it also does not cover any employers who insure themselves and are thus subject solely to federal, rather than state, regulations. This law was intended as a direct rebuke to Trump and his Cabinet; the fact that it was drafted, passed, and signed within a matter of weeks is actually quite a remarkable feat for the Massachusetts state government. Both the health insurance industry and the reproductive rights community supported the bill and helped to negotiate the resulting language. In addition to the birth control access without cost-sharing, the bill also expands coverage by allowing a one-year supply of birth control pills, by increasing the types of birth control covered, and by covering the so-called “morning after” pill without a prescription.
Generic Drugs and the PTAB
Originally posted on Philly.com, George Consortium member Robert I. Field highlights the threats that the GOP tax reform proposal would pose to nonprofit hospitals.
By Robert I. Field
Nonprofit hospitals have had much to fear from Congress recently. The Senate came within one vote of repealing much of the Affordable Care Act, which would have left millions of patients uninsured and unable to pay for hospital care. And Congress may soon consider major cuts to Medicare and Medicaid, which could slash reimbursement for many hospital services.
CT Court Rules that State Cannot Vaccinate Children in its Temporary Care Without Parental Consent
By Gregory Curfman, MD
When the Hatch-Waxman Act was passed into law in 1984, it established the generic drug industry and thereby forever changed the marketplace for prescription drugs. Today 80% or more of all prescriptions are filled with generic drugs, which has resulted in a savings of $1.67 trillion from 2007 to 2016. To incentivize generic drug entry into the market, the Hatch-Waxman Act provides that the first generic company to submit an Abbreviated New Drug Application (ANDA) will have the exclusive right to market its drug for 180 days. This provision, referred to as “first to file,” provides a strong financial inducement to file an ANDA early.
Smart Gun Technology and the Potential to Save Lives
By Elisabeth Ryan
The Supreme Court of Connecticut has, for the second time in three months, ruled that the state Department of Children and Families cannot vaccinate children in its custody without explicit parental consent. News outlets have proclaimed in alarmist headlines that “State Can’t Vaccinate Kids in Temporary Custody,” but that’s untrue – Connecticut can continue to vaccinate children in its temporary custody, as long as the parents agree. The state is not actually prohibited from vaccinating any and all children in its custody, but the decision is still concerning from a public health perspective.
Navigating Minor Consent Laws Toward Confidential PrEP Access for Adolescents
By Elisabeth J. Ryan
In the 1970s, a California man designed a magnetic lock that could be installed in the revolvers used by law enforcement, rendering the gun inoperable unless the user was wearing a special ring with an opposing magnet. This device, designed so that someone who grabbed a police officer’s gun would not be able to turn that gun back on the officer, represented the first “smart gun” technology (and can still be purchased today for a mere $420). Beginning in the 1990s, technology entrepreneurs and even gun manufacturers began to develop more sophisticated firearm technology designed to “prevent shootings, both intentional and unintentional, by children, thieves, and other unauthorized users.” But developers faced vehement opposition, not from anti-gun activists pursing a once-vocal push for individual disarmament but from very loud and very angry gun rights activists. Technology development withered. Both Colt and Smith & Wesson abandoned federal grants for such projects after suffering a “revenue-crushing boycott” from their customers because of the research. Of course, the mere fact that the federal government administered such grants led some to question whether the money for public safety technology improvement was really “a smoke screen to eventually take all handguns that are not smart guns out of the hands of law-abiding U.S. citizens...”
Making America Healthy Again: Analyzing Trump's Take on the Social Determinants of Health [from Health Affairs Blog]
By Jason Potter
According to the CDC, as of 2015, youth ages 13-24 comprised a staggering 22% of all new HIV infections in the United States. Given this alarming incidence rate, developing new and effective HIV prevention modalities for adolescents and young adults, and eliminating major delivery barriers, has become a priority. In the sphere area of biomedical HIV prevention for at-risk adolescents, one legal barrier looms large. The issue of caregiver consent (or the less inclusive “parental consent”) forms an oppressive threshold barrier to operationalizing biomedical HIV prevention among at-risk adolescents under the age of majority.
American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health
George Consortium member and Northeastern University professor Patricia Illingsworth concludes on the Health Affairs Blog that the Trump administration shows "little interest in addressing the social determinants" of health, such as "education, socioeconomic status, poverty, the physical and social environment, employment, and discrimination, among others..."
"Graham-Cassidy" Provides Zero Funding to Address the "Opioid Crisis"
By Micah Berman, Wendy E. Parmet, and Jason A. Smith
Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public. This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.
Briefly: Rescinding DACA Will Harm Public Health
By Elisabeth J. Ryan
One of the few positive provisions of the summer’s Senate “health care” bills was the inclusion of funding to states to “support substance use disorder treatment and recovery support services.” With more than 30,000 people dying from heroin and painkiller overdoses in the United States every year, sufficient funding to address and effectively treat the issue is crucial. Yet the latest version of the “health care” bill has omitted this funding entirely.
Federal 'Right to Try' Legislation - perpetuating a misguided skepticism towards the FDA [From CRITical Thinking]
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 Safer Way to Legalize Marijuana [from Health Affairs Blog]
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.
Briefly: Massachusetts Governor Proposes New Crime of Manslaughter for 'Drug Dealers'
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.
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.
"Right to Try" May Do More Harm Than Good
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.
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.”