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HIV Criminalization in the United States

Since the onset of the AIDS epidemic in the early 80s, public health officials and lawmakers have proposed legislative approaches to prevent HIV transmission at both the national and state level. lawmakers have tried to address this issue using punitive measures by enacting laws that criminalize high-risk behaviors linked to negligent HIV exposure. Twenty-five states criminalize behaviors that increases the risk for HIV exposure; and some states include low-risk behaviors like oral sex. Most of these laws were enacted before the emergence of antiretroviral therapy, and the laws do not account for other preventative measures such as condom use and pre-exposure prophylaxis (PreP).

States also criminalize intentional STD exposure, but typically result in short sentences (rarely exceed thirty-four months). Similarly, all states have assault and battery laws and other criminal statutes that can be used to prosecute high-risk behaviors that can lead to negligent HIV exposure. Despite its intention, state laws further sanction and stigmatize those with HIV. In addition to criminalizing certain behaviors, state law also determines the maximum sentences for violating HIV-specific statutes. The CDC reports that eight states issue sentences for HIV-specific violations between eleven and twenty years in prison; while two states impose longer sentences (greater than twenty years), and two may impose up to life in prison.

LGBTQ advocates outline how many of these laws were rooted in homophobia but gained traction by claiming to promote public health. Not only do they have a disproportionate effect on LGBTQ individuals, but these laws have a disparate impact on women and people of color. Aware of this discriminatory effect, the California legislature introduced Senate Bill 239 in February 2017. This bill reduces HIV transmission from felony to misdemeanor and repeals mandated criminal penalties for donating blood, organ, and breast milk while being HIV-positive. Unfortunately, not many states have followed suit.

Experts in AIDS research have long resisted these laws, claiming that they are ineffective and unwarranted. Linda-Fail Bekker, a professor of medicine at the Desmond Tutu HIV Foundation says, “in many cases, these misconceived laws exacerbate the spread of HIV by driving people living with, and at risk of, infection away from treatment services.” The science of dispelling HIV stigma is insufficient to end HIV criminalization. Lawmakers must consider the overarching human rights principles and advance public health efforts and education to adequately address the criminalization of HIV in the US.

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FDA Regulation of Underage ENDS Use and the Incidence of Fatal Lung Disease.

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.

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Google, Fitbit, and the Sale of Our Private Health Data

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.

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We the Pat[i]ents: HHS v Gilead

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.


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States Take Regulatory Measures to Protect Youth from E-Cigarettes

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.

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