Category: Blog

The 21^st century has ushered in an era of incredible advancements in medicine. From the first uses of online patient portals to nanomedicine, how people are treated for their health has changed drastically. It then follows that as medicine itself develops, the regulations and protocols surrounding medicine change with it. In the United States, the Food and Drug Administration (FDA) is the gatekeeper of all new medicines. Each year, the FDA approves only dozens of novel drugs, approving fifty-five in 2023 and thirty-seven in 2022. At the end of 2023, the FDA approved the first CRISPR/Cas9-based gene therapy for treatment, implicating new questions surrounding regulations of the powerful yet controversial technology and its other applications. 

CRISPR/Cas9 is the nickname for “Clustered Regularly Interspaced Short Palindromic Repeats” and “CRISPR Associated Protein 9.” It is the leading technology for editing the human genome. The applications of CRISPR are virtually limitless, from treating genetic diseases to organ transplantation to altering the genetic code of future generations. The FDA approved clinical trials of CRISPR for treating genetic diseases in 2021, effectively treating patients with sickle cell disease. In just a few short years, these treatments were greenlit for treatment in the United States. However, as CRISPR technology advances, regulations have limited its other uses. Currently, there is a ban in the United States on using federal funds for editing the genes of future generations while embryos (i.e., “germline editing”), prohibiting the FDA from approving any clinical trials for such modification and the National Institute of Health (NIH) from funding research. However, germline editing is not technically illegal in the United States—any research must use only private funding, though it is globally discouraged. The question is: are the existing regulations on germline gene editing proper? 

There are clear ethical concerns about editing human embryos that make it widely acceptable amongst researchers that the brakes have been pumped on developing the technology, which isn’t quite ready for human trials. The lack of a specific ban on embryonic research has led some to push for stricter regulations to eliminate it altogether. There are concerns about genetic diversity becoming limited over time, which would not be seen within the first generation of genetically modified persons but later on. While a parent may undoubtedly want to edit a genetic disease out of their child, it becomes a public policy concern about generations down the line that may be adversely affected by dwindling genetic material. Further, unborn children cannot consent to alterations—and those alterations aren’t always accurate, and could lead to additional health issues. 

Conversely, some have argued for looser regulations on germline gene editing, specifically in favor of research forthree-parent embryos. This involves using DNA from the father and the mother as well as mitochondrial DNA from a donor mother to prevent mitochondrial diseases from being passed onto the child. Properly done, it would help couples conceive while mitigating or eliminating the risk of passing on genetic diseases. This is a less controversial use of the technology already approved for clinical trials in the United Kingdom, but research has been dampened in the United States by the above regulations. 

While CRISPR has recently received FDA approval for some applications, its use has been hindered in others. As the technology produces more treatments, it will gain efficiency and accuracy with increased research on the new type of medicine. With this increased accuracy, it may come time to reevaluate the current regulations regarding germline editing. Some may argue that Congress, the FDA, and the NIH have not done enough to restrict it and need to ban research on germline editing immediately. Others may argue to allow federal funds to be used for research and increase reproductive freedoms. Regardless, there is a growing conversation surrounding the use of CRISPR gene editing in medicine that has only become louder following FDA approval for one application. 

The stakes in the 2024 Presidential Election are monumental for women’s health in ways that extend far beyond abortion access. Kamala Harris’ presidency is crucial not only for the preservation of reproductive rights but also for safeguarding the broader landscape of women’s health care that is under dire threat from Trump’s regressive policies. Women’s healthcare access is already fractured, and another Trump administration would deepen this divide, worsening outcomes and eroding access to essential services on which millions of women rely.

“After…nobody even coming close, I was able to kill Roe v. Wade…and put the Pro Life movement…over the Radicals that are willing to kill babies even into their 9^th month, and beyond,” Trump boasted on Truth Social, his Twitter dupe. 

Despite the declaration of many legal scholars that it would not be possible for Trump to overturn Roe, he kept his 2016 campaign promise to appoint Supreme Court justices to do so.

During his term, Trump appointed three Supreme Court justices, a number not seen since Nixon. Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett happily bolstered the conservative majority, enabling the end of the federal right to abortion through Dobbs v. Jackson Women’s Health Organization, a decision a majority of Americans oppose.

The former President’s incessant and deranged rhetoric on abortion shifts the conversation away from critical issues in women’s health. In the presidential debate of this election with Harris, Trump repeated false claims that Democrats support abortion “after birth” and “executing” babies. This constant stream of misinformation brings discussions of women’s health to a frivolous standstill. Rather than advancing the conversation to address the unintentional consequences of Dobbs, such as the mass exodus of obstetricians from the most restrictive states, we must debunk “execution” claims. 

We must recenter women at the heart of conversations surrounding abortion rather than sensationalizing egregious soundbites because the consequences are deadly and permeate every layer of healthcare available to women. The collateral damage to cancer screenings, contraception, and prenatal care is vast, creating a healthcare environment where women’s health is chronically underfunded and underprioritized. Pregnant women diagnosed with cancer cannot properly access their treatment under abortion restrictions. Additionally, abortion restrictions have led to more high-risk pregnancies being carried to term. As a result, we have seen a seven percent increase in overall infant mortality since Dobbs.

The Republican Party has united around a platform that systematically diminishes women’s rights and access to healthcare. Harris stands against this regressive agenda, yet the Democratic Party remains fractured. Many further on the left are considering “protest votes” for third-party candidates like Jill Stein, despite the undeniable reality that such votes could swing the election towards Trump, so much so that Republican-aligned super PACs have been working to boost Stein in crucial states, such as Georgia. This division is self-destructive, ignoring the real consequences of protest votes.

Voting in this election is about choosing your opponent. A third-party vote may feel like a principled stand, but it’s ultimately an exercise in futility that only helps to empower Trump and his aggressive, anti-woman agenda.

Trump’s strategy isn’t limited to just abortion restrictions; it spans a comprehensive rollback on women’s health access, with nationwide implications. As noted by Michelle Obama, a single-term president can reshape the judicial landscape for decades, casting shadows on crucial healthcare rulings that impact more than reproductive freedom alone.

The Democratic Party needs a unified front to win this fight. It’s essential to consider the practical implications of this election and move beyond ideological purity.

Pediatric obesity has been called “an epidemic within an epidemic” by the American Academy of Pediatrics. This condition causes hypertension, type 2 diabetes, and more, but has the potential to cause severe illnesses in adulthood such as cancer and cardiovascular disease. The number of cases diagnosed every year has been increasing, and within the different severity levels of the condition, severe obesity diagnoses have been increasing at the highest rate. This particular diagnosis raises a grave public health concern because it has been linked to extreme health conditions such as premature mortality. 

In the past, federal government legislation that addressed childhood obesity centered on the prevention of the condition, as opposed to treatment. As recently as 2021, the Reducing Obesity in Youth Act was introduced to the U.S. Senate. It was meant to prevent and manage this disease after the COVID-19 pandemic exacerbated the number of cases and their potential repercussions. This act focused on the need for food security, and fitness and nutrition education in schools. It did not address possible medical interventions. 

However, in the last five years, there has been a shift towards the adoption of pharmaceutical and surgical interventions as treatment for this condition. In 2019, the FDA approved Victoza, a GLP-1 receptor agonist, which is also used in Ozempic, for patients aged ten and older. Then in 2020, the agency approved Saxenda, another GLP-1 receptor agonist drug, for patients over the age of 12. Now, a recent study released in September 2024 in the New England Journal of Medicine asserted that Saxenda is safe for patients as young as six. 

The stance on surgical intervention for young obesity patients has also changed. In 2019, the American Academy of Pediatrics published a policy statement addressing current treatments for childhood obesity and discussed the use of surgical intervention to treat the disease. 

Pediatric obesity disproportionately affects Black and Hispanic children, and also becomes more prevalent as a child’s household income decreases. This could restrict access to treatment for those who most need it, but the Affordable Care Act of 2010 mandates Medicaid coverage for obesity treatment and intervention for any insured patient over the age of 6.

While the government has an interest in ensuring the health of younger generations as an investment in the future, the long-term effects of these pharmaceutical and surgical interventions are unknown.  These treatments have only been made available to children and teenagers in the last few years. Given the absence of longitudinal studies, the government finds itself in a difficult position where it must act to combat the current childhood obesity epidemic, but it does not know what the eventual repercussions of these early interventions will be. 

There must be consideration of the long-term efficacy of these methods, the issue of informed consent in pediatric surgery, the growing contention around surgical weight loss interventions, and the personal, medical, and financial costs of a possibly lifelong reliance on GLP-1 drugs. There are also concerns about the legality of these government projects, including accusations of government overstepping and the creation of a so-called “nanny state.” On a more personal level, there are concerns about the social and psychological effects of addressing obesity in such a clinical manner. 

Pediatric obesity is a critical issue that is affecting some of the nation’s most vulnerable children. The shift in health policy from prevention and education to direct medical intervention has occurred rapidly, but we must proceed cautiously. After all, these children are the future, and we must be wary of hurting them in our haste to save them. 

On Thursday, September 26th, Alan Eugene Miller was put to death in Alabama by nitrogen gas asphyxiation. Nitrogen is a physiologically inert gas, meaning that it has no toxic or anesthetic properties. When inhaled, nitrogen dilutes the concentration of oxygen in the blood to dangerously low levels. This deprives cells in the body of oxygen, which ultimately leads to unconsciousness and death. Nitrogen gas asphyxiation, which involves inhaling pure nitrogen gas through a respirator mask, was recently authorized as a method of capital punishment by Alabama in 2018 due to a shortage of lethal injection drugs. Miller is the second person ever to have been executed by nitrogen gas asphyxiation; this method was used for the first time in the world when Alabama executed Kenneth Eugene Smith in January of this year.

Nitrogen gas asphyxiation was intended to be a more humane or painless alternative to other forms of capital punishment such as lethal injection, but eyewitness accounts of Miller and Smith’s executions have cast doubt over this theory. During the executions of both Miller and Smith, they thrashed and convulsed violently on the gurney for the first several minutes of the execution and spent several additional minutes gasping for air before they finally stopped breathing. It took approximately 22 minutes for Smith to stop breathing after he began to inhale the nitrogen gas, and witnesses were reportedly “alarmed” by the ordeal. A reporter for the Associated Press who had been present for most executions in Alabama stated Smith’s reaction to the nitrogen gas asphyxiation was “not typical for what you see in a normal execution.”

The recent implementation of nitrogen gas asphyxiation as a novel form of capital punishment has raised serious questions regarding cruel and unusual punishment and medical ethics. Prior to his execution, Smith’s legal team filed a brief in the U.S. District Court for the Middle District of Alabama Northern Division in an attempt to halt the execution using nitrogen gas, stating that this method would put him at severe risk of a persistent vegetative state, stroke, the painful sensation of suffocation, superadded pain, or other permanent injuries in violation of the Eighth Amendment should the execution end in failure. Following the execution of Smith, the use of nitrogen gas asphyxiation as a form of capital punishment was also condemned by the UN High Commissioner for Human Rights Volker Türk, citing “serious concerns this novel and untested method of suffocation by nitrogen gas may amount to torture, or cruel, inhuman or degrading treatment.” 

Additionally, Smith’s lawyers argued in their brief that certain procedures should be implemented to decrease the risk of failed nitrogen gas asphyxiation, such as having a medical provider present during the execution. However, the American Medical Association’s Code of Medical Ethics forbids physicians from participating in a legally authorized execution. Considering the alarming reaction exhibited during both Smith and Miller’s executions, it is concerning that improving the efficacy of nitrogen gas asphyxiation and reducing the risk of complications or superadded pain (and therefore mitigating potential violations of the Eighth Amendment) by having a physician present would be a direct violation of the code of ethics that physicians in the United States are required to follow. At this time, it is likely that this method of execution will continue to be used in Alabama as over 40 other death row inmates have selected nitrogen gas asphyxiation as their method of execution, and several other states have also authorized lethal gas as an execution method. Further investigation into Miller and Smith’s executions is necessary to shed light on whether this method complies with current medical ethics, human rights, and the Eighth Amendment.

Federal, State, and local laws all play a massive role in perpetuating healthcare inequities. Preemption is the idea that when two authorities conflict with each other, the higher authority of law will displace the law of  lower authority. In recent years, many states have restricted local laws regarding public health policy through preemption.  This practice became popular in many states during the COVID-19 pandemic, where many local governments were enacting orders to deal with the pandemic.  Many states, such as Iowa, Oklahoma, and Tennessee in turn enacted statutes stating the local governments could not impose certain restrictions, such as requiring citizens to wear masks or show proof of vaccination.

However, problems with state preemption do not stop at purely public health matters. The effects of this new trend will have significant effects on many different regulations, such as economic opportunities, housing, employee benefits, and technology, which all, in turn, can have a severe effect on healthcare and access to healthcare. This use of preemption is important for many reasons, as the states can now utilize preemption to cause harm to many citizens, contributing to the already wide gaps of health disparity.

For example, laws such as requiring businesses to provide for paid family leave and raising the minimum wage for local workers are some proffered by local governments.   However, state laws have shut many of these laws down. Requiring businesses to provide paid family leave can promote public health when there is a short-term disability, sickness, or something else short-term in a family.  This time off would allow the family or person to recover, therefore promoting public health at the local level. However, if states do not allow for this paid time off, many are forced to work through their disabilities, sickness, or other problems. Further, another common local law is adding a local sales tax to smoking and vaping products to prevent youths from obtaining and using them.  However, these once again are struck down at the state level. These laws would prevent the adverse effects of smoking and vaping among youths, which could be a huge problem in the community, but the local government is preempted by state laws.

State legislatures are using this doctrine to advance anti-LGBTQ+ healthcare bills, especially in southern states.  In recent years, states have blocked local LGBTQ+ nondiscrimination protections, banning gender affirming healthcare, and targeted curriculum in schools. For example, in March 2024, Alabama recently passed an Anti-LGBTQ bill which preempts protections for LGBTQ individuals at the local level. There are numerous examples of these types of bills that are being introduced and passed into law daily. This is detrimental for LGBTQ+ healthcare, and is one of the many ways state preemption of local laws is affecting people today. 

Overall, preemption removes opportunities for effective, local public health action and instead prevents leaders from tackling problems in their community.  Local leaders are better at framing the issue, building local partnerships, and getting the message out to the communities. The weight of preemption today is much heavier than it was five years ago, and this needs to change for city leaders to effectively respond to the changes and problems in their communities. To combat these issues, federal and state governments should avoid framing preemptive legislation in a way that hinders public health initiative in the community. way that hinders public health initiatives in the community. The federal and state governments need to fully anticipate and understand the effects their preemptive laws will have on local communities moving forward.

In the wake of the Dobbs v. Jackson Women’s Health decision, the future of the clinical research landscape for women’s health has largely been in question. Recent data suggests that the U.S. is moving backward when it comes to pregnancy-related complications and continues to have the highest rate of maternal mortality among high-income countries. Females make up over half of the U.S. population, but medical conditions that affect them continue to be underfunded at alarming rates. According to the National Institutes of Health, 80% of maternal deaths are preventable, but severe maternal morbidity has almost doubled in the last ten years. Despite 80% of those who are pregnant taking at least one medicine, pregnant women and women of childbearing potential have long been excluded from many medical trials. When women experience pregnancy, their pre-existing conditions do not go away, but the understanding of them largely does.

Even before the Supreme Court’s pivotal decision in Dobbs, the United States has experienced major challenges when it comes to inclusion and representation in clinical trials. Paternalistic views on protecting women and their future children allowed women to be excluded from trials based on their reproductive potential until 2000 when the Food and Drug Administration required their inclusion for trials involving life-threatening diseases. Restrictions on pregnant women were even more stringent due to “potential fetal risk.” Women of color, and black women specifically, have long been underrepresented in clinical trials, despite knowledge that many conditions such as gestational diabetes, affect women of color at a higher rate than white women. 

The decision in Dobbs will only further the gender and diversity gap in clinical research. Researchers are likely to cease trials in states where access to abortion is restricted due to increased liability to themselves and their patients. Research into birth control and hormone therapies could now be viewed as illegal. Trials, especially involving reproductive treatments, often involve regular pregnancy tests. A positive test followed by a miscarriage could cast suspicion onto both providers and patients and in states such as Texas, both could be liable for criminal prosecution. In states where abortion access is available, patients might be more hesitant to enter trials due to an overall environment of increased scrutiny of their personal health decisions.

The potential harm to women’s health in America cannot be overstated. Due to increased concerns over legal risks, the costs to include female participants in clinical trials will increase and will likely have an adverse effect on the number of women included in trials broadly. Because medication affects men and women differently, decreasing the percentage of women in clinical studies will reduce the safety and efficacy of new treatments. Healthcare providers may face increasing situations where they must decide whether to prescribe medication to a pregnant woman without knowing the effects it may have on their patient’s health or their fetus. The majority of Black Americans now live in restricted states, largely in the Deep South, and are likely to be summarily excluded from participating in trials where a drug could pose a potential risk to a fetus. The process of clinical research as we know it is likely to be rewritten.