Category: Blog

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In March, the FDA finally approved Sage Therapeutics’ drug Zulresso (brexanolone) as the first drug intended to treat postpartum depression (PPD) in adult women. Before Zulresso, the only drug used to treat PPD was anti-depressants. Compared to anti-depressants, which could take weeks to regulate PPD symptoms, Zulresso improves symptoms within days. The approval of Zulresso marks a crucial milestone for women who have long suffered from PPD.

Having a baby is supposed to be a joyous occasion, however, within days, or even hours, many women feel depressed. Some women experience the less severe form of the “baby blues” while others suffer from severe and life-threatening PPD. PPD is a major form of depression that occurs in about 1 in 9 women after childbirth. PPD symptoms vary but often include feelings of extreme sadness, anxiety, suicidal thoughts, and severe doubts about the mothers ability to care for her baby. All women are susceptible to PPD because PPD does not manifest itself in one “type” of person, i.e. specific race, culture, etc. Some experts believe that PPD is more prevalent than reported because not all women talk about or seek treatment for PPD. Zulresso is the first drug to provide hope to the millions of women who suffer from this disorder. 

Yet, although Zulresso seems like a saving grace, it is still a drug that comes with serious risks. The FDA reported that serious risks, like excessive sedation or sudden loss of consciousness, occurred after taking Zulresso. Because of these risks, Zulresso was approved with a Risk Evaluation and Mitigation Strategy (REMS). A REMS program helps ensure FDA that the benefits of the drug outweigh its risk and that patients taking the drug are safe. In Zulresso’s case, the REMS program makes Zulresso available only through an intravenous (IV) injection that must be administered and monitored by a health care provider. Since Zulresso takes a total of 60 hours to administer,the REMS program requires patients to be continually monitored the entire administration period. In addition, all patients must be registered and complete counseling before taking Zulresso. 

However, a drug this powerful won’t come cheap. A one-time infusion of Zulresso is expected to cost $34,000 before discounts. For many women without insurance, Zulresso may be unattainable. However, since Zulresso has been clinically proven to be effective for PPD, many women will find its price worth it. Even Sage’s chief executive officer, Jeff Jones, acknowledged the high price of Zulresso, and said that “Zulresso’s medical benefits will overcome any concerns about cost and delivery.” 

Zulresso is expected to launch in late June, and Sage Therapeutics is already working on creating centers for women to have access to the drug. Although the nation is excited about Zulresso, Sage Therapeutics is already working on another fast-acting antidepressant pill that could treat postpartum depression too. However, Zulresso and Sage Therapeutics might have some competition from Marinus, a company also developing and testing a drug to treat PPD. Competition or not, the approval of Zulresso means that fewer women have to suffer and many more women can enjoy motherhood.  

The labor and delivery process has evolved immensely over the years in the types of procedures and use of medication. More patient focused than ever, the trends towards natural water births, pre-planned C-sections, and hiring doulas are likely to continue. However, while the physical toll a woman experiences in giving birth is obvious, the emotional and psychological burden is often carried alone and in secret. Women are talking about their struggles with postpartum depression and the traumas associated with giving birth. In lawsuits, women’s claims include being forced to undergo painful invasive vaginal procedures against their consent, feeling imprisoned to a bed for hours at a time, and even having their birthing plan completely ignored by staff. All of these indicate abuse at the hands of doctors and nurses whose primary focus is the birth of a child and not the woman in labor. Women should have the right to make choices about their bodies. This type of “obstetric violence” has led to an uptick in diagnoses of postpartum PTSD, which is often misdiagnosed as postpartum depression. 

This trauma has led a growing number of women to turn to alternative birth plans that avoid hospitals and put the mother in control of her birthing process. Many of these birthing plans occur in a tub or pool, filled with warm water, and incorporate types hypnotherapy and calming techniques to ensure a smooth and serene process. Proponents of this movement include midwives, who are trained in child birthing, and doulas, who assist and advocate for birthing women during the process, who emphasize that healthy women with uncomplicated pregnancies are usually more satisfied with the process than their previous births in hospitals. Natural water birth is praised for having lower cost, more freedom to choose medications or methods, less pain/anxiety, a comfortable and peaceful setting, and a personal connection to the process. However, critics argue that for difficult births, women who insist on natural water birth put both themselves and their baby at a higher risk for complications, or even death. If there is distress, bleeding, or other unknown conditions, the ability to get help and necessary care is more difficult and will take longer. In the UK, doctors are discussing a consent requirement for vaginal pirths beacause the risks of vaginal birth are so high and debating whether it should be the default option. Others discourage the notion that “natural birth is fulfilling while unnatural birth is traumatic” because it disenfranchises women who want to make the choice to have a C-section or epidural as part of their labor and delivery process. Regardless, experts agree natural water birth is a safe and successful birthing plan when well planned and executed. 

Unfortunately, across the United States laws are being passed that constrict a pregnant woman’s opportunity to choose a natural birth. Many doctors refuse to indulge in a natural water birth, which forces women to seek out midwives to facilitate their birthing plan. Twenty-three states refuse to license midwives, driving up the cost of natural water birth and making it less safe for those who insist on it. Like abortion, placing obstacles on water births do not stop them from happening. Some states, like Arkansas and Arizona, even require “vaginal assessments” prior to clearing a woman for a water birth, which is comprised of a series of STD testing and invasive vaginal examinations that a woman giving traditional vaginal birth in a hospital does not have to undergo. New York has attempted to reduce the number of water births by minimizing the number of facilities that would be prepared to facilitate them to three, for the entire state’s population. The effect of this is to limit the freedom of a women to control their birthing plans by requiring them to jump through hoops, increase costs, wait on impossibly long wait lists, and in some cases, even jeopardize her own safety just to exert any authority on the extremely painful and intimate process of bringing a child into the world. It is time for state laws to catch up with modern birthing practices and to give women the power to make their own decisions about their bodies as they give birth. 

The Trump Administration has undergone setbacks recently in its attempt to reshape the health care landscape. Since the 2017 failure to repeal the Affordable Care Act (ACA) through Congress, the Administration has attempted to use agency power to affect changes to provisions of the ACA. Such changes have been inspired from Republican proposals to limit federal involvement in health care and granting significant discretion for states to run their own programs.

The Centers for Medicare and Medicaid Services (CMS) has directly dismantled many of the provisions of the ACA through expanded approval of state waivers for Medicaid compliance. Under Section 1115 of the Social Security Act, the Secretary of Health and Human Services (HHS), through CMS, can grant states waivers on Medicaid requirements to allow states greater flexibility in shaping their health care programs. This effort has been one of the cornerstone programs under Seema Verma, the CMS Administrator. Administrator Verma previously oversaw the expansion of Indiana’s Medicaid program in 2015. Then-Governor Mike Pence made a deal that Indiana would accept Medicaid expansion in exchange for requirements that enrollees contribute monthly payments to offset some of the cost to the state. That was a unique arrangement at the time, but some in the Obama Administration felt that it would be the only way to get reluctant states to accept an expanded Medicaid program. Once the Trump Administration came into office, CMS began to examine the ability to grant Section 1115 waivers in relation to mandating work requirements for Medicaid recipients. In January 2018, Kentucky became the first state to tie Medicaid expansion to work requirements for enrollees. Seven other states have since successfully applied for waivers to require employment to receive benefits. These waivers have been challenged in court a number of times; Kentucky in particular lost twice. A District Judge in Kentucky blocked implementation of the work requirements in June 2018, holding that HHS had failed to properly consider the request and remanded it back for further examination. The waiver was reconsidered and granted for a second time. However, last week, the same judge once again blocked Kentucky’s program as well as blocked Arkansas’ work requirement waiver, holding that the waivers go against the spirit of Medicaid’s goals.

Eight states in total have expanded Medicaid with the condition that enrollees be employed or seeking work. Utah passed a referendum in the 2018 elections that expanded Medicaid access but the Utah Legislature limited that expansion by requiring enrollees to be employed and raising the income threshold for eligibility. Virginia’s 2018 Medicaid expansion was approved after several years of negotiation as the Republican controlled Virginia General Assembly would only support expansion in exchange for limited work requirements. Georgia has most recently accepted a very limited Medicaid expansion that forbids complete expansion and sets a June 2020 deadline to agree to a waiver or the expansion will be voided.

The most recent legal setback for the Administration has been the rejection of the Department of Labor’s (DOL) association health plan rules (AHPs). These rules allowed for small businesses to join together to purchase health plans, similar to how large employee plans are already structured. The AHPs would not have to abide by many of the coverage requirements the ACA mandates, but would require insurance to cover individuals with pre-existing conditions. Eleven states, led by Pennsylvania, filed a lawsuit against the DOL, alleging that the AHPs violate both the ACA as well as well as violating ERISA guidelines on allowing for groups to join together in AHPs even though they do not have any business connection. Last week, a District Judge invalidated the DOL rule, holding that DOL’s interpretation goes against the language of ERISA.

One legal success for the Administration was the December 2018 ruling by a Texas District Judge finding the ACA was unconstitutional. In NFIB v. Sebelius, the Supreme Court found that the individual mandate, which requires individuals to maintain health insurance and penalizes them if they don’t, was constitutional under Congress’s taxing power because the penalty was treated as a tax. The Texas District Court Judge’s ruling found that because the penalty under the individual mandate was reduced to zero as part of the Tax Cuts and Jobs Act of 2017, the mandate could no longer be justified as a tax and the whole law was thus unconstitutional. Many court watchers do not believe the lawsuit will ultimately succeed at the appellate level, but the Department of Justice (DOJ) recently reversed its position in a brief filed with the U.S. Court of Appeals for the Fifth Circuit, refusing to defend any part of the ACA, believing it to be unconstitutional in whole. The DOJ’s previous position was that only the individual mandate was unconstitutional but the rest of the law could be upheld if the mandate was not. Recognizing the political implications of such a change, the Republican attorneys general of Ohio and Montana filed an amicus curiae with the Fifth Circuit urging them to reject the conclusion that the entire ACA is unconstitutional and limit scrutiny to the individual mandate.

The legal setbacks on a narrowing of provisions of the ACA have once again put a spotlight on health care within the political sphere. President Trump recently declared that, “The Republican Party will soon be known as the party of health care.” Republicans in particular are concerned that this reexamination of the ACA will endanger their 2020 reelection prospects and thus, are blocking attempts to reexamine the ACA. Senate Majority Leader Mitch McConnell has rejected any new attempt to repeal the ACA, viewing any opportunity impossible with the Democrat controlled House of Representatives. The issue of health care will continue to be a pressing political issue as the House of Representatives examines various proposals for ‘Medicare for All’ programs and the Republicans focus on many of their initiatives to bring down health care costs through drug pricing issues and other non-coverage focused initiatives.

As of the publication of this
article, 2019 has already seen recalls of twelve
medical devices. Most recently, Two Medical Technologies, Inc. recalled
automatic transport ventilators due to a
potential risk of fire. But these are likely not all of the devices
that should be recalled. The Food and Drug Administration (FDA) hid
reports about harm caused by medical devices. In its article
discussing these reports, Kaiser, a healthcare delivery system, profiled a
surgeon who was using a surgical stapler to seal tissue around someone’s
appendix, but the stapler locked up. Over two-thirds of surgeons he talked to
about this issue experienced a similar malfunction. The FDA apparently had
granted the makers of these staplers a special exemption “allowing them to file
reports of malfunctions in a database hidden
from doctors and from public view.” This database, MAUDE, includes
serious injury and malfunction reports for about 100 medical devices. More than
one million reports of malfunctions or harm spanning about fifteen years remain
in the database. The FDA has been notified of 5.4
million adverse events between 2008 and 2018. While some
malfunctions are openly reported, thousands more are hidden.

The FDA’s Center for Devices and
Radiological Health is tasked with regulating
medical devices. There are three risk categories that essentially determine the
level of scrutiny they receive during the regulation process. Class I devices
are not at all highly regulated, and do not
actually have to do what they claim to do as long as they are adequately
packaged and properly labeled. Class II devices—which are considered medium
risk and could hurt patients if misused—also do not receive a high level of
oversight, especially if it is a device that is substantially
equivalent to a device already allowed on the market. Class III
devices must go through a premarket authorization scientific review process
before approval. However, there are several loopholes
in the regulatory process. First, medical devices often are not tested in
humans before they are released on the market. Second, there is not systemic
way for the government, researchers, or patients to spot problems in the
process. Third, there are not many protections for patients who are harmed by
medical devices.

Class III devices are still not
being regulated enough. The FDA needs to re-evaluate its regulation process,
particularly for Class II and Class III devices. It does not seem that the
“substantially equivalent” test and the premarket authorization process are
working. These sorts of loopholes are creating problems in the medical field.
For instance, if the FDA was actually regulating medical devices, 80,000
deaths due to malfunctions could have been prevented. People would
potentially not be permanently paralyzed, burned, and otherwise permanently
damaged otherwise. Even when devices cause problems, they are rarely
pulled from the market.

The FDA may
not always know the extent of risk before the medical device reaches
the market. But there are ways to mitigate these problems before recalling the
devices. One surgeon has called for mandatory
registration of all implantable devices. The FDA has also called for
human
testing and, for at least one type of medical device, has required
companies to submit a report on devices already
on the market. The FDA recently said that it will start actively
watching how devices perform once on the market, rather than relying only on
patients to report problems. Hopefully in the coming years, the FDA will no
longer see huge medical device recalls.

While two distinct fields, medicine and technology are two areas
that are under constant improvement. Medical improvements are necessary to
continue to combat new invasive viruses, treat current diseases with no cure,
and keep unknown illnesses at bay. Technological improvements are necessary to
help create efficient tools for mankind’s everyday use. Accordingly, technology
has been a huge factor to help create medical improvements. As a result, a
fairly new type of medical and technological improvement has gained exposure:
Nanotechnology.

What is Nanotechnology?

Nanotechnology is a branch of technology that deals with
dimensions and tolerances of less than 100 nanometers, especially the
manipulation of individual atoms and molecules. It is science, engineering, and
technology conducted at the nanoscale, which is about 1 to 100 nanometers. In
comparison, a nanometer is the equivalent width of three to five atom molecules
wide. The size of
a virus is typically 100 nanometers. Some of the most important application
fields of nanotechnology are medicine and pharmaceuticals.
Within the medical field, the current applications are: appetite control,
cancer, cholesterol, drug development, imaging, medical tools, bone
replacement, chemical substitute, diagnostic tests, hormone therapy, and immunosuppressants.

Applications

Because nanotechnology allows scientists to attack illnesses
at a molecular level, there are many applications for the technology in the
medical field. Some
common uses are quantum dots and drug and gene delivery.

Quantum dots (“Qdots”) are “semiconductors that emit or
absorb light under specific conditions that can be manipulated externally.”
Qdots, they can be used to locate ill or bad cells and scanners are used to
target the previously emitted light from Qdots. As such, its application could
target potential tumors in the body and diseased cells in general.  

The targeted drug and gene delivery application allows for
the identification of ill cells in the body. With the help of Qdots,
needed medication is delivered to the exact part of the body without harming
the healthy cells. Nanotechnology increases efficiency through the use of pills
as opposed to complex and time-consuming therapies, which can be costly and less
effective.

The future also provides promising use of nanotechnology for
tissue engineering
and extensive cancer treatment. Such applications would be used to rebuild
tissue at a molecular level or even identify and destroy cancer cells before
malignant formation is visible.

Potential Legal
Implications

Although there is minimal case law that addresses the issues
of nanotechnology in medicine,there
exists the possibility of harm and injury that may arise from this technology.
Because nanotechnology affects the body at a molecular level, cellular injury
may be harder to detect. However, as technology improves, it may be easier and
may take less time to determine the injury and harm, if any, nanotechnology causes.
For example, if the nanotechnology used to fix cancerous cells malfunctions and
instead begins attacking healthy cells, this could prove to be detrimental.
Shorter attacks on healthy cells may not demonstrate instant signs of harm, but
overtime, the body may begin to react to the unknown effects and show signs of
harm and injury.

Other legal implications that may arise seem to appear in
nanotechnology’s most important benefit – early detection of diseases. One
issue arises through the use of Qdots in nanotechnology. Once Qdots
are used to illuminate the ill cells, doctors and medical professionals
diagnose the issue and begin to treat the ill cells, or in this case the
disease. However, misdiagnosis or failure to treat may create legal implications
like malpractice suits. Also, a cure or treatment may not be available at the
time of diagnosis, which may lead to more legal implications.

Lastly, potential legal implications may arise from a
failure to warn about the risks inherently involved with nanotechnology usage. Although
this aspect is pretty common in malpractice suits against doctors, it is
important to note that in this instance the harm occurs at a microscopic level.
Thus, as stated above, overtime, such damage may have detrimental effects to
the human body.

Overall nanotechnology is an exciting advancement in the
medicinal world. It can be very efficient and effectuate change in untapped
ways. Its potential is limitless. Unfortunately, new technology in the
medicinal field implies new harms and risks. Looking at the current
applications of nanotechnology, the medical benefits may outweigh the risks and
harms involved.