Category: Blog

The Food and Drug Administration (FDA) has tightened its regulation
of e-cigarettes and other electronic nicotine delivery systems (ENDS) since it
promulgated a rule extending existing tobacco regulations to ENDS in August of 2016.
Many of these regulatory developments occurred under former FDA Commissioner
Scott Gottlieb with the objective of curbing widespread underage use of ENDS and
continue even after Gottlieb has resigned his post as commissioner.

In September 2019, the Trump administration asked the FDA to
ban flavored e-liquids amid a surge in underage use of ENDS, and as hundreds of
cases of life-threatening or sometimes fatal ENDS-related lung illnesses occurred.
Studies have indicated a strong likelihood that flavored e-liquids draw teenagers
to ENDS use, so this ban could be an important step in lowering underage ENDS
use in those who already use the devices, and in deterring other minors from
experimenting with nicotine use in the first place.

However, the FDA’s previous attempts to restrict the
availability of a wide array of e-liquid flavor options were unsuccessful.
Underage use of ENDS has been a problem for several years, but support for this
regulatory measure has only grown substantially in the months leading up to
September 2019. The difference in support appears to be related to the numerous
instances of illnesses and deaths caused by ENDS-related lung disease in recent
months which is a separate problem from the ongoing issue of ENDS use by
teenagers.

Where instances of teen use of ENDS are often linked to lax online sales policies and the appeal of flavored e-liquid, investigations by the CDC and FDA have linked many of the recent instances of lung illness to the use of illegally tampered with vaping products. Because of the differences in the causes of these problems, they might not both be solved by a ban on most of the currently available e-liquid flavoring options. Many of the products associated with serious lung injury and death have been bought illegally online and have been adulterated by third parties. The adulterated ENDS components frequently contain compounds, such as cannabidiol and tetrahydrocannabinol, found in marijuana. Therefore, the new flavor regulations promulgated by the FDA do not directly address the increase in ENDS-related lung illnesses.

Banning many flavors in e-liquids and other ENDS components,
can have a positive impact by addressing problems with underage use of these
products. However, many supporters of the new rules expect a decline in the
instance of life-threatening ENDS-related lung illness to occur as a result of
the restrictions of e-liquid flavors. Such a decline might not occur until the
devices causing lung illness are removed from the stream of commerce. Therefore,
more restrictions on the availability of illegal ENDS products online could
help to address this issue going forward.

On November 1, 2019, Google’s Senior Vice President of
Devices and Services Rick Osterloh announced in a blog
post that Google had entered into an agreement to acquire Fitbit, Inc. This
move signaled Google’s efforts to become a leading company in the $25
billion wearables market after failing to make a splash with its own line
of Wear OS products. However, many current Fitbit customers and privacy watchdogs
are concerned over the implications
the sale will have on the privacy of the health data that Fitbit collects.
The current lack of legal protection over health data collected by wearable
technology and the inherent value of consumer data to Google’s business model
presents a problematic combination that could see an erosion of consumer
privacy.

The primary legal structure governing the use of personal
health information (“PHI”) is the Health Insurance Portability &
Accountability Act of 1996, commonly referred to as HIPAA. The purpose
of HIPPA is to mandate industry-wide standards for health care information
and require the protection and confidential handling of PHI. Over the past two
decades, the framework HIPAA established has become central to the
protection of PHI and has held healthcare providers accountable in
instances where PHI has been exposed.

Yet the rise in wearable technology and its functionality in
recent years has exposed a gap in HIPAA protection. As the law is written,
HIPAA does
not apply to health data collected by wearable health technology. This is
because HIPAA only governs organizations considered to be “covered entities,”
which the law states
as either a health plan, a health care clearinghouse, a health care provider,
or health care. Fitbit, as an organization that only collects health data for
its customers’ own use (e.g. tracking step count for the user to view) and not
to provide health care services, does not qualify as a covered entity. As a
non-covered entity, Fitbit is not required to abide by the HIPAA-mandated regulations
for the protection of PHI even though the nature of the information it collects
(e.g. name, address, phone identification number, height, weight, heart rate,
etc.) qualifies
as PHI as defined by HIPAA. Thus, users are left to rely upon Fitbit’s self-published
privacy policy and the notion that the company will not breach or change
that policy for the protection of their sensitive information.

Fitbit currently collects data from its 28
million active users, and even showed off the power of its data last year
by showcasing
trends it gleaned from 150 billion hours of heart data, the largest set of
heart-rate data ever collected. This type of large-scale data collection and
use falls perfectly in line with Google’s own business practices in recent
years. According to a 2018
report, Google is one of the largest collectors of personal data—even
collecting more than Facebook. Google uses its hardware, websites, and
applications to actively and passively collect as much data on its users as
possible. The Associated
Press found that even when users disabled the “location history” feature in
several Google websites and applications, Google was still collecting and storing
users’ locations.

This data has become one of Google’s most valuable assets.
Data is the driving force behind Google’s ability to effectively deliver ads,
which accounted for 83.75%
of its 2019 Q3 revenue. Google’s ad revenue has also increased year-over-year
from $21 billion in 2008 to $116 billion in 2018. A company whose primary
source of revenue is the use of data for targeted ads will gain unfettered
access to one of the largest health data sets in the world. This is why,
although Fitbit and Google both stated that Fitbit data would not be used in
Google ads, many critics are
skeptical of Google’s intentions.

Google is poised to control vast amounts of our personal
data and can
use it from targeted ads (e.g. ads for running shorts based upon increased
running activity) to conducting beneficial or agenda-driven medical research. However
the data is used, Google is gaining increased access to our most sensitive and
personal information, not protected by HIPAA, while remaining a company whose
main goal is not public health. This lack of legal protection over PHI data
collected by wearable technology—and the immense value of data to Google’s
business model—present clear privacy concerns for consumers that will only continue
until action is taken to expand HIPAA in order to effectively protect all PHI.

On November 6, 2019, the US
Department of Health and Human Services (HHS) filed suit against pharmaceutical
manufacturer Gilead Sciences, Inc., seeking damages against the company for infringing
on HHS patents for pre-exposure prophylaxis (known as “PrEP”) for HIV
prevention.  Gilead manufactures and
sells two pills—Descovy and Truvada—for use in a PrEP regimen.  In an online statement released the same day,
HHS claims that Gilead received approval from the US Food and Drug
Administration (FDA) to produce Descovy and Truvada for post-infection HIV
treatment, and following taxpayer-funded research by the US Centers for Disease
Control and Prevention (CDC), Gilead obtained FDA approval to use the drugs as
preventative treatment—despite not obtaining licenses to use the patents.

Two decades after the AIDS epidemic
began, CDC researchers developed medications to prevent HIV infection after
exposure.  According to the CDC, the
government’s patented regimens are 99 percent effective at preventing HIV
contraction after exposure to the virus. 
According to HHS, the US Patent and Trademark Office granted four
patents allowing HHS to license (and receive royalties for) CDC’s PrEP
regimens.  HHS alleges Gilead refused to
reach a licensure agreement with the government on multiple occasions.

AIDS activist organizations, such
as PrEP4All, have urged HHS to collect royalties from Gilead, arguing the
manufacturer used the government’s (and taxpayer-funded) intellectual property
to raise prices for Truvada.  Accusations
of Gilead’s “price-gouging” practices led to a House Committee on Oversight and
Government Reform hearing in May.  During
the hearing, lawmakers asked Gilead’s CEO about Truvada’s prices overseas—in
Australia, the drug only costs $8 per person per month.

Gilead has argued that rising costs
support research.  In 2004, when Truvada
was first approved as HIV treatment, its monthly wholesale cost was $650.  When the drug was approved for a PrEP regimen
in 2012, its cost rose to $1,159, according to research from Truven Health
Analytics.  The pill is now over $1,750
per month, or $21,100 per year, though health insurance can offset
out-of-pocket costs.  The drug brought
Gilead $3 billion in sales last year.

To help patients obtain the drug,
the company offers the Gilead Advancing Access program to help eligible
patients pay for their medication—and even patients with commercial health
insurance might not have a copay.  In the
spring of 2019, Gilead donated enough medication to cover up to 200,000
patients over the next 11 years. 
However, only 10 percent of those who need the drug receive it.

This past summer, Gilead challenged
the government’s patents.  A Gilead
executive corroborated HHS’ claim that the manufacturer and the agency could
not reach a license agreement during several years of discussions.  In a November 7 statement published in STAT,
a Gilead spokesperson claimed the patents granted to HHS for PrEP and PEP
(post-exposure prophylaxis) are not valid, and that HHS filed for patents
without alerting the manufacturer, which it was obligated to do.  The company argues that HHS’ patents are not
valid because other entities developed antiretroviral therapies for PrEP and
PEP before HHS claimed invention in 2006. 
The company also claims that it invented Truvada, funded the clinical
trials that led to FDA’s 2004 approval, spent $1.1 billion in research and
development for the drug—including for subsequent studies on PrEP regimens—and
similarly bore costs for Descovy.

According to the activists, HHS could use royalties to fund HIV prevention efforts and treatments.  On the same day that HHS filed suit, the Journal of Acquired Immune Deficiency Syndromes published a study from Abbott Laboratories and the University of Missouri, Kansas City, announcing that scientists discovered a new strain of the HIV virus—the first in 19 years.

SOURCES: Available upon request.

Over the past decade, electric cigarettes or
commonly referred to as e-cigarettes have become a blossoming market as
technology has upgraded traditional cigarettes. 
The e-cigarette industry has urged that vaping is a “safer” method of
smoking. In August 2019, e-cigarettes claimed its first victim. 
Earlier this year, the Center for Disease Control reported the
hospitalization of a young man in Illinois for a respiratory related illness
that was attributed to vaping. Eventually the young man succumbed to his
illness.  Since the first incident, the
CDC has attributed an additional thirty three respiratory-related deaths to
routine vaping habits.

Why is vaping so popular? As technology
evolves, so does the method people used to inhale tobacco.  Whether the delivery is a pipe, a cigar, a
cigarette, or—today’s method—e-cigarettes, tobacco is tobacco is tobacco.  Regardless of the tobacco product, the use of
tobacco increases health risk of the user.
The popularity of vaping grew when companies released flavored vaping oils
and tobacco products, which attracts a new, younger market.

If you offer a child a
lollipop, they will gladly accept it, so comes as no surprise that teenagers
and young adults are attracted to e-cigarettes, especially with flavors like
strawberries or cotton candy.  States
have tried to address this issue by passing statutes to restrict the minimum age requirement to
purchase e-cigarettes to 18 or 21.  This
hasn’t stopped teenagers and young adults from purchasing
e-cigarettes.  The United States Surgeon
General reported in 2018 that e-cigarette use increased among high schoolers by
78%.  So, what can the legislature do to discourage
the sale of e-cigarettes to young people?

States are considering passing statutes
prohibiting the sale of flavored e-cigarettes and other e-cigarette
regulations.  In the meantime, state
executive offices have taken the lead on dealing with this issue.  Montana Governor Steve Bullock directed the
Montana Department of Health and Human Services to issue a temporary ban on flavored e-cigarettes until
the state can determine what type of action to proceed with.  Montana is not alone; Michigan has also banned the sale of flavored
e-cigarettes.

Other states have taken this battle into the
courthouse.  The state of New York has filed suit against twenty-two
online flavored e-cigarette vendors accusing them of creating a “public
nuisance” by selling targeted flavors to youths under the state age limit.

State regulation has not gone unnoticed by the
e-cigarette industry.  One of the largest
e-cigarette retailers, JUUL, has announced it will suspend the sales
of flavored e-cigarettes.  This isn’t the
only change at JUUL. In September, the retailer replaced its CEO, Kevin Burns,
with K.C. Crosthwaite, the CGO for Altria, a traditional tobacco company.  JUUL also announced it will suspend all
television, print, and digital advertisements. 
The e-cigarette industry is feeling the financial effects of the various
bans.  Altria reported a 19% loss in stock prices
over since the beginning of 2019.

Even with all the
government regulation and voluntary removal of products, consumers can still
purchase unflavored tobacco and mint e-cigarettes.  Whether the sale of these products will be
enough to keep the industry afloat is undetermined.  What is certain is that a wave of change is
rushing towards the e-cigarette industry which could drown the entire
industry.  Compliance with government
regulation and consumer claims could cause serious damage to the e-cigarette
industry.

Financing long-term services and supports (LTSS) presents a
concern to older adults, lawmakers, and society at large. LTSS refers to those
services that meet a person’s routine health and personal care needs when he no
longer can perform these tasks on his own, often due to age or disability.
Affording LTSS is a challenge, as few people have the necessary financial
resources to meet its high costs, and many must eventually turn to Medicaid for
help. Medicaid is the largest payer of LTSS, covering 43 percent of national
LTSS spending in 2013 (Nguyen). Concerns arose over the
sustainability of Medicaid’s role in financing LTSS in anticipation of an aging
baby boomer population that will need LTSS. One solution intended to ameliorate
LTSS financing is the Medicaid Estate Recovery Program (MERP), which requires
states to recover payments from individual estates for long-term care services (Estate Recovery). However,
this program which is characterized by Rachel Corbett as “Medicaid’s Dark Secret,”
tends to bring more distress than actual revenue.

MERP intends to control LTSS costs by providing a way for
states to recoup the money spent on a recipient’s care. Since the beginning of
the Medicaid program in 1965, states have had the option to recover from the
estates of deceased beneficiaries over age 65 when they received benefits (MACPAC).            However, the highly billed savings
of estate recovery have yet to materialize.

In 2005, the AARP Public Policy Institute published a study analyzing the first decade of
mandatory estate recovery. The study found that Massachusetts collected an
average of $16,442 per estate in 2003; offsetting a little more than one
percent of its LTSS costs in total. That one percent made its efforts among the
most effective in the nation. In contrast, the average amount recovered from an
estate in Kentucky was $93, representing just 0.25 percent of its LTSS costs.
The total amount states recovered increased from $72 million in 1996 to $347
million in 2003. Nonetheless, estate recoveries accounted for less than one
percent of Medicaid’s total nursing home costs in 2003. Corbett notes that the
“overwhelming majority” of estates recovered under MERP are not worth the
hundreds of thousands of dollars needed to make an impact on Medicaid LTSS
spending.

MERP,
thus, seems more punitive than economical. As described above, the average
amount recovered from an estate is far from the amount needed to reimburse the
billions of dollars spent on LTSS. Financing LTSS presents one of the greatest
challenges our healthcare system will face in the upcoming years. While
Medicaid has met this need for now, its role as the primary LTSS payer is
unsustainable. MERP was billed as a solution to manage the strain LTSS puts on
state and federal budgets, but the program, with its slim returns and human
cost, is not the answer. A few states have already responded to these concerns
by scaling back their estate recovery programs (Corbett). More state lawmakers should
consider following their lead.

Before
parties reached a $260 million settlement, litigation was set to
begin this month to determine whether drug companies are responsible for the
opioid crisis that reached Cuyahoga County and Summit County of Ohio. The
lawsuits brought by these Ohio counties are just two of the over 2,000 pending
lawsuits in response to the opioid crisis. Since 1999, the opioid crisis has resulted
in over 200,000 overdose deaths in
the United States. The
Court consolidated pending opioid-related lawsuits into what is now referred to
as the National Prescription
Opiate Litigation.

The bellwether trial which focuses on the two Ohio
county lawsuits was intended to try a widely contested issue and typically is representative
of the other cases. This trial would likely shape how courts conduct those other
pending opioid-related cases.

Before
pharmaceutical companies began marketing opioid treatments for a wider range of
uses, opioid medication was only prescribed in cases of extreme need.  In the late 1990s, the pills
started being prescribed at higher rates and their highly addictive
nature soon showed. The Drug Enforcement Agency’s Automation of Reports and
Consolidated Orders System (ARCOS) nationwide analysis illustrates the magnitude of the
prescription pain pills supplied to states and counties. For example, one West
Virginia county was supplied with 38,269,630 pills, or enough prescription pain
pills to provide each person 203 pills annually between 2006 and 2012.

Lawsuits
against drug companies accuse drug manufacturers of marketing their opioid
treatments in a way that failed to adequately disclose the risk of addiction
and overdose. In the suit that just settled, the Ohio Counties accused defendant distributors
of failing to properly  “detect, probe or report suspicious
orders.”
Defendants denied these allegations and asserted that they
complied with federal regulations to provide medicine to people suffering from
painful conditions, that doctors who over-prescribed the opioids are to blame,
and that the DEA had the information necessary to stop the opioid pills
from entering the black market.

Litigation
did not occur as planned for the Ohio county case because on the morning of the
trial start date, drug maker Teva Pharmaceuticals and drug distributors
McKesson, Cardinal Health, and AmerisourceBergen agreed to a $260 million settlement. Other parties to a similar
settlement included companies such as Johnson & Johnson, Mallinckrodt, and
Endo International and Allergan. Johnson & Johnson reached a $20.4 million
settlement, Mallinckrodt reached a $30 million settlement, and Endo
International reached a $10 million settlement with up to an additional $1 million
worth of medications provided to the counties. Despite settling, none of the
listed defendants admitted liability.

As of
late October, Walgreens has not settled and will likely
go to trial within the next six months. It argues that it is different
from the defendants who already settled because it merely fills prescriptions
and never manufactured, promoted, or prescribed any opioid medications.

Today,
the Centers for Disease Control and Prevention estimates that the opioid crisis
has a $78.5 billion economic burden annually
across the United States alone. The goal of this Ohio case was to provide funding for what is
expected to be a decades-long recovery process. There is already discussion regarding the
distribution of the settlement money. While reaching settlements with these Ohio counties avoided litigating
this trial, the settlements do not resolve the other 2,000 pending cases.