Category: Blog

We rang in 2019 with a federal government shut-down. The thirty-five day shut-down commenced at midnight on December 22, 2018.  On January 25, 2019, President Trump declared the government reopened and funded until February 15, 2019. In the wake of our country’s longest federal government shut-down to date, which might not even be finished, we are forced to examine the very real consequences  for citizens during such times.

            The effects of a long-term federal
government shut-down are insurmountable. The recent shut-down impacted the Food and Drug Administration (FDA) in many ways. The FDA is a crucial player when it
comes to medical products, drugs, and food safety. The recent shut down
certainly effected the FDA’s ability to operate wholly, and subsequently put
our country’s health at risk.

            Thousands of FDA employees considered non-essential
were furloughed and the FDA had to pause routine regulatory and compliance
activities. For instance, during the shut-down, the FDA was unable
to accept new medical product applications that required payment or to review drug
applications that were not user-funded. Applications
typically take several months to review. The FDA’s
Center for Drug Evaluation and Research was forced to put all non-emergency
over-the-counter monograph drug activities
on hold because they were determined not
to address immediate threats to human life and safety. More
than ten drug makers were expecting  FDA
decisions in March, weeks after the agency was expected to run out of money. During the shutdown, the FDA used carryover
“user fee” subsidies to resume review of
certain applications that required a user fee, such as New Drug Applications,
Biologics License Applications, and Premarket Approval applications for medical
devices if the fee had already been paid. Still, the FDA was unable to accept
new user fees during the shutdown. If fee payment was required, sponsors had to
postpone review until the government reopened. Some companies and industry
segments, such as allergenic products, discussed  excepting user fees and chose to rely on
budget authority. Thus, when budget authority lapsed, assessment for those
products ceased, unless review was warranted because there was an emergency
involving the safety of human life.

FDA foreign food inspections continued, almost normally, because they were considered essential. But the FDA basically had to stop inspecting domestic food production facilities during the shut-down. This means threats to the public, like bacteria outbreaks, were potentially going undetected. Much of FDA’s funding appropriated by Congress was put on hold. Therefore, decisions had to be made based on an analysis of importance and imminence. The most urgent inspections would be at facilities with prior safety issues, such as factories with listeria, salmonella contamination, or other hygienic problems. Next came foods that were more prone to contamination. For example, cheese might be a high-risk food, and a facility that manufactures crackers would be low risk, according to Scott Gottlieb, commissioner of the FDA.

Besides the logistical issues of ranking tasks by importance, he went on to explain how difficult the circumstances were for the employees. “We are trying to build accommodation in for people who have unusually difficult circumstances,” Gottlieb said.

            As we
approach mid-February, time will tell how President Trump’s three-week plan
went, and what is in store for the FDA and our health moving forward.

DNA testing companies, like 23&me, Ancestry.com, and
MyHeritage, have gained popularity. In 2017, 12
million people tested their genealogy, doubling the number of people
tested from the previous year. An estimated 1
in 25 American adults have had their DNA tested. Indeed, there are DNA
testing companies for animals, such as Wisdom panel, which is a canine
DNA testing site.

Recently, a genealogy service was used to catch the Golden
State Killer, a serial killer who has been linked to more than fifty rapes and
twelve murders from 1976 to 1986. The case has been cold for decades, but
interest in the case was revitalized with Michelle McNamara’s book entitled I’ll Be Gone in the Dark. The California
police had the Golden State Killer’s DNA in a preserved sample and uploaded his
DNA sample to GEDmatch. GEDmatch is a
website that provides genealogical analysis (such as discovering unknown
relatives) using DNA profiles generated by larger commercial DNA testing
companies. The Golden State Killer’s DNA was matched to the Killer’s distant
relative, allowing the police to narrow down the suspect to Joseph James
DeAngelo, a 72-year-old former police officer.*

The Golden State Killer is not the first case where law
enforcement has used a genealogy site to narrow down or find a suspect. One of
the first cases solved using familial DNA searches was the mutilation and
murder of Lynette White in England in 1988. The White murder was a notorious
unsolved case until the early 2000s when the police found a new DNA sample,
which they matched to a 14-year-old boy whose DNA was on file. The 14-year-old
boy led to his uncle, who confessed to the murder.*

Since this is a new technology, it is unclear how and what
type of Fourth Amendment protections the courts will provide to DNA data
obtained through commercial genealogy testing. The courts may apply the third-party
rule, which allows police to search—without a warrant—information given to a
third party because a person does not have a reasonable expectation of privacy
in information he voluntarily turns over to a third party. The courts have
applied this doctrine to allow warrantless searches of bank records, U.S. v. Miller, 425 U.S. 435 (1976),
phone numbers dialed, Smith v. Maryland, 442 U.S. 735 (1979), and
email addresses, U.S. v. Forrester,
512 F.3d 500 (9th Cir. 2008). Courts might rule that, like historical cell site
information from a suspect’s cellphone, genetic information provides an
“intimate window into a person’s personal life.” But this is unlikely since the
courts allow law enforcement to obtain DNA samples from suspects and analyze
the sample by running it through criminal databases. Maryland v. King, 569 U.S. 435 (2013).

The American Civil Liberties Union stated in an op-ed
piece that uploading a suspect’s DNA profile on a public site, like
GEDmatch, infringes on the suspect’s privacy right because the penalty for his
crimes does not include releasing information about his entire genetic makeup.

Before the courts start hearing cases on familial DNA
searches, Maryland and the District of Columbia have banned familial DNA
searches. Md. Code Ann. Pub. Safety § 2-506; D.C. Code § 22-4151. Other states,
like California,
Virginia,
and Colorado,
regulate the police’s use of DNA searches.

Companies have also released policies on providing data to
law enforcement. 23andme announced in a Privacy Statement that
the company will not provide information to law enforcement unless required by
a court order, subpoena, or search warrant.

Police are likely going to keep pursuing suspects through
familial DNA searches since, overtime, it will become more fruitful. Currently, 60%
of white Americans can be identified through genetic testing services,
whether or not they have themselves gotten the genetic test, and researchers
predict that within two to three years, 90% of white Americans can be
identified through genetic testing services.

*Information for this paragraph of the post was obtained from
two sources: Avi Selk, The ingenious and
‘dystopian’ DNA technique police used to hunt the ‘Golden State Killer’ suspect,
Wash. Post (Apr. 28, 2018), https://www.washingtonpost.com/news/true-crime/wp/2018/04/27/golden-state-killer-dna-website-gedmatch-was-used-to-identify-joseph-deangelo-as-suspect-police-say/?noredirect=on&utm_term=.c3d45ee09344;
Gina Kolata & Heather Murphy, The
Golden State Killer Is Tracked Through a Thicket of DNA, and Experts Shudder,
N.Y. Times (Apr. 27, 2018), https://www.nytimes.com/2018/04/27/health/dna-privacy-golden-state-killer-genealogy.html.

Health care was the number one issue on voters’ minds in last week’s midterm elections. Throughout the country, state and local ballot initiatives focused on health care issues such as Medicaid expansion, access to abortions, medical marijuana legalization, and more. On the campaign trails, the overwhelming majority of Democratic candidates touted popular provisions of the Affordable Care Act and made promises to offer continued protection to patients with pre-existing conditions. In the face of the ACA’s growing popularity among constituents, some Republican candidates made first-time pleas to protect such patients, but many avoided stumping on health care after failing to repeal the ACA last year.  

Over the next two years, Americans should expect two things concerning federal health care legislation. First, a Republican-controlled Senate and Democrat-controlled House will likely prevent the passage of any meaningful, sweeping health care legislation. Second, that same gridlock will likely prevent remaining key ACA provisions from being repealed by legislation. As a result, states and localities are the likely battlegrounds on which health care policy debates will be fought. This much was revealed on election night itself. 

Voters in Idaho, Nebraska, and Utah joined 34 other states and the District of Columbia by expanding Medicaid coverage to more low-income individuals. In fact, an estimated 325,000 people are expected to gain access to Medicaid as result of the passage of those three ballot initiatives. Though Kansas, Maine, and Wisconsin did not feature Medicaid expansion as ballot initiatives, each state elected a Democratic governor who campaigned on the issue. Prospective legislation to expand Medicaid in those three states would provide access to coverage to an additional 325,500 individuals.  

Marijuana legalization was on the ballot in four states this past election. Voters in Michigan made the Wolverine State the 10th in the country and 1st in the Midwest to legalize recreational marijuana. Voters in Utah and Missouri legalized medical marijuana, raising the total number of states that allow medical marijuana to 33. However, a similar medical marijuana initiative failed in North Dakota. Notwithstanding, Democratic governors-elect such as J.B. Pritzker in Illinois, Laura Kelly in Kansas, and Tony Evers in Wisconsin joined colleagues in expressing desire to introduce legalization legislation during their terms.  

Voters in Alabama and West Virginia, a state which re-elected Democratic Senator Joe Manchin, passed ballot initiatives which will explicitly ban abortion in their state constitutions with 59% and 51.7% of support, respectively. Although these initiatives passed, the Supreme Court precedent set in Roe v. Wade precludes a constitutional ban on abortion. Nonetheless, such support may indicate further legislative challenges to the landmark case in those states’ legislatures and courthouses. In contrast, 64% of Oregon voters rejected a proposal to prohibit the use of public funds for abortion. 

Voters across the country should not hold their breath if they are waiting for federal single-payer health care or the repeal of the ACA. Those prospective legislative proposals will not disappear during the next two years of bifurcation in our legislative bodies, but they are very unlikely to materialize. What is far more likely, and what we already witnessed on election night, is that state action and debate concerning health care reform promises to be robust and gritty. After these midterm elections, 45 million additional Americans find themselves under Democratic governance. The success or failure of each party to enact meaningful health reforms on state and local levels could very well inform this country’s next election, and by extension, the federal health care landscape. 

In the United States, people with severe mental illness are three times more likely to be in a prison instead of a mental health institution. Forty percent of people with severe mental illness will also spend time in a jail, prison, or correctional facility. There are many people with mental health issues who are being punished, including being executed and kept in solitary confinement.

 

Even though people with intellectual disabilities may not be executed under the Eighth Amendment, the Supreme Court has held that people who are mentally ill may still be executed, including people will severe mental illnesses, and only that the insane may not be executed. The “insane” is defined as “those who are unaware of the punishment they are about to suffer and why they are to suffer it.” But the Court has also said that the Eighth Amendment requires prison officials to provide a system of ready access to adequate medical care, including mental health care. However, states have not always followed the Court’s guidance, particularly when it comes to solitary confinement and the death penalty. Between 2010 and 2017, twenty-six percent of prisoners who were executed had a history of mental illness or were treated with psychotropic medication. Currently, between five and ten percent of death row prisoners are estimated to be suffering from a mental illness.

 

In October 2018, Yale Law School issued a report that over 4,000 prisoners in solitary confinement have a mental illness. Solitary confinement can often exacerbate or even trigger a prisoner’s mental health issues. Prisoners are kept in total isolation for twenty-two hours per day for at least fifteen consecutive days. In New Mexico, for example, sixty-four percent of prisoners with mental health issues were kept in solitary confinement. Unfortunately, prisoners who are kept in solitary confinement often leave more mentally damaged than when they entered, and are less likely to successfully reenter society.

 

The prison system must change to help prisoners who have a history of mental illness, and not further criminalize them. Many states are considering legislation to end the practice of executing prisoners with a mental illness and there are other states that are ending or restricting solitary confinement. For instance, in the fall of 2017, Colorado established a procedure to immediately provide prisoners with treatment rather than place them in segregated lock-up.

 

Prisoners can also have difficulty obtaining treatment because their insurance may no longer cover their medications and they also do not have reliable access to therapy while in prison. Mental Health America made suggestions to improve mental health access for the incarcerated, including investing in mental health courts and creating systems of support for people who are incarcerated or recently released and who need access to a community-based service. States can also reevaluate Medicaid exclusions on prisoners, so prisoners can still obtain their medications and their mental health issues will not be exacerbated while incarcerated. Authors of an article in the American Journal of Public Health have additionally suggested providing telemedicine, integrated family counseling, and cognitive-behavioral therapies to complement medication and also reduce levels of reoffending. There also need to be better transitional plans for prisoners to reintegrate into the community and still obtain mental health treatment. Prisoners who received a professional diagnosis of a mental health disorder were seventy percent more likely to return to prison when they did not have any correctional intervention and treatment.

 

It may also be prudent to determine whether a new mental health standard should be established for prisoners who develop mental health issues while in prison. The Supreme Court will soon decide a case about the execution of a man who developed severe mental health issues will in prison, in which case there may be an answer soon.

For at least the last decade (as long as I can remember growing up), the health risks of tobacco and smoking cigarettes were obvious.  The movement to raise awareness about the dangers of smoking was well underway, as television commercials, printed advertisements, and teachers were educating young people about nicotine’s addictive qualities and the link between smoking and certain cancers.  Growing up in the 1990s–2000s, there was no doubt in our minds smoking was bad.

As times progress, obviously so does technology.  Every day it seems like technology endlessly advances as new and better gadgets hit the shelves. Better phones, better cameras, everything.  Now, however, the tobacco industry has intersected with the tech industry as the popular e-cigarette, or Juul, has gone viral. You likely see people smoking these thumb-drive looking gadgets on a daily basis.  Juul, as a company and brand, does not hide that their products contain nicotine and that nicotine is an addictive substance.  They market themselves as the first viable alternative for adult smokers. Their website even warns “smoking is bad for your health, and those who don’t currently use nicotine products should not start.” Even with this effort to promote safety and health, the e-cigarette craze has brought with it a great deal of health problems and arguably caused new risks rather than merely creating an alternative to old ones.  Why is it that young people, who have always known the dangers of cigarettes, start using the Juul?  Is it Juul’s marketing and targeting techniques?  Is it our inherent need in 2018 to have the newest, coolest technology?  This, of course, is hard to say.  But the problems are real, and the FDA has now stepped in and has particularly focused on Juul’s risks towards young people.

So, what is a Juul and how is it different from a cigarette? The Juul is a compact, USB-shaped vaping device. It is similar to other e-cigarettes, says cardiologist Holly Middlekauff, M.D., professor of medicine and physiology at the David Geffen School of Medicine at UCLA.  “The liquid is pretty much the same. It has solvents, nicotine, and flavorings,” Middlekauff told MensHealth.com. The solvents help deliver the nicotine and flavors in the form of tiny particles into the lungs. Unlike other e-cigarettes, the Juul is compact and rechargeable; and additionally has an internal temperature-regulating mechanism that prevents it from overheating or even exploding. The Juul has become particularly popular on social media, especially among young people. But as trendy as it is, the device still contains nicotine and is a major health concern, say medical experts.

In April 2018, FDA Commissioner Scott Gottlieb announced that he was forming a Youth Tobacco Prevention Plan aimed at stopping youth tobacco usage.  The FDA led a surprise inspection of the headquarters of Juul Labs in late September, retrieving more than a thousand documents it said were related to the company’s sales and marketing practices.  The FDA said it was particularly interested in whether Juul deliberately targeted minors as consumers.  “The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens,” the FDA said in a statement. “It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”  The agency has given Juul and four other e-cigarette manufacturers a 60-day deadline to produce plans showing how they will limit access to teenagers.  It will certainly be interesting to see if this trend will go out of style soon, or if the FDA will need to take further steps to re-teach our youth the dangers of nicotine and cigarettes.