Ethics in Medicine: Dilemmas in Healthcare Part 2

The four principles of ethics discussed in Part 1 of this series are not always binding, but rather, should be applied in all circumstances unless there is a more important factor that must be considered for the greater good. While ethical codes are established as principles that a consensus of medical professionals believe in, they often do not address situations that occur on an individual basis. Two main issues in bioethics today are euthanasia and religious liberty in health care.

Euthanasia
There is an ethical dilemma in the choice of caring for individuals nearing the end of life for prolonged periods of time when there may be little benefit in doing so. Euthanasia is the process of a doctor ending someone’s life by painless means, which provokes debate about whether doctors should be able to deliberately end someone’s life with their consent. There are two main types of euthanasia: active euthanasia and passive euthanasia. Passive euthanasia is the less controversial type: it allows the patient or their family to withhold life-sustaining treatment such as opioid medications, a ventilator, or a feeding tube. Active euthanasia occurs when medical professionals or another person deliberately gives lethal drugs that end the patient’s life. In classical ethics, there is a moral difference between actively killing a patient and refraining from actions that would sustain the life of the patient. However, others argue that because both types of euthanasia are done with the intent of the patient’s death, there is no substantial difference between the two types if they are administered with proper consent. In 1990, the United States Supreme Court approved the use of passive euthanasia, and some states have adopted Death with Dignity Acts, allowing physicians to assist terminal patients in ending their life if they are expected to die within six months.

Religious Liberty in Healthcare
Addressing a patient or caregiver’s religious beliefs that may conflict with certain medical practices is also an ethical problem. This can involve a patient’s religious objection to procedures such as vaccination, or a doctor’s religious objection to treating someone whose lifestyle violates their religious beliefs. Many state laws include conscience clauses, which protects the rights of doctors and medical professionals to withhold treatment that violates their religious or moral values, such as abortion, sex reassignment, and euthanasia. In 2014, the Supreme Court ruled in Burwell vs Hobby Lobby that the government cannot force private companies to provide insurance that covers birth control methods if it violates the employer’s religious beliefs. Some activists and ethics professionals disagree with this Supreme Court decision and with the wide use of conscience clauses: they believe that the expansion of religious liberty for doctors could endanger some groups from receiving emergency care and decrease the availability of contraception for women.

To better address these ethical issues, many healthcare facilities establish an ethics committee that creates formal policies to better resolve issues. However, these ethical dilemmas will continue to be hotly contested at the personal, federal, and global levels.

Books About Ethical Dilemmas and the Practice of Ethics
For further exploration, here are four books widely acknowledged as innovative or informative in developing a more-complete understanding of medical ethics:

  • Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present by Harriet Washington
  • The Spirit Catches You and You Fall Down by Anne Fadiman
  • The Immortal Life of Henrietta Lacks by Rebecca Skloot
  • Bioethics: Principles, Issues, and Cases by Lewis Vaughn

Situations that create conflict between bioethical principles show how the study of bioethics is not always clear cut and has many contrasting opinions within the field. However, the improvements to health care that have resulted from the adherence to these principles show that bioethics is an integral part of creating a better and more equitable healthcare system. The study of bioethics may appear abstract and theoretical, but the forms, practices, and procedures you encounter at the doctor’s office or hospital are governed by the special standards of bioethics to ensure the best care and future for you and all patients.

References:

Ethics in Medicine: How Bioethics Builds a Framework for Providing Care Part 1

Part 1: The Foundation of Ethics in Healthcare

Determining ethical standards is a priority in any field that involves choices, experimentation, and human interaction. The healthcare industry is no exception. Medical staff aim to establish standards that encourage humane, morally-sound patient care and research. Implementing a system of ethics, or moral principles that determine what is right and wrong, is one way to regulate medical practices. However, creating one consistent ethical code across national healthcare is difficult, given that beliefs often differ across societies and cultures. So how does one determine the role of ethics in the healthcare field?

Bioethics refers to the ethics involved in medical and biological research and is often applied to healthcare settings as well. These are commonly used to guide professionals when they must make choices that cross into potentially subjective territory. Below, we explain the basics of bioethics and how they can be applied in healthcare settings.

Principles of Medical Ethics

Though bioethics researchers differ on the exact ethical standards healthcare professionals should follow, four principles from Thomas Beauchamp and James Childress explain common understandings of bioethics: respect for autonomy, non-maleficence, beneficence, and justice.

Respect for autonomy refers to the idea that a patient has the right to control their own body and the ability to make informed, voluntary decisions. This means that a patient’s decisions should be respected so long as they are able to think freely. For example, if individuals that follow certain religions refuse to undergo procedures like blood transfusions, this principle argues that their wishes should be respected given the assumption that they are rational individuals.

Nonmaleficence means that healthcare providers cannot intentionally harm a patient and any potential danger must be minimized as much as possible. In situations where harm is inevitable, it is the responsibility of the professional to choose the option that causes the least injury. This principle ties in with respect for autonomy when a patient makes the decision to abstain from life-saving treatment if the treatment would cause too much suffering or pain.

Beneficence states that medical staff members serve as a benefit to patients and are tasked with preventing the patient from experiencing harm. This principle differs from nonmaleficence in that although providers should never directly harm anyone, they can choose the patients they wish to benefit through permitting specific individuals into their practices or prioritizing the care of one over another. At times, beneficence can take precedence over respect for autonomy in situations when the patient cannot think independently, and medical providers must make the decision to help them without their consent.

The fourth principle, justice, asserts that individuals are equal and should be treated as such. This means that quality medical care and resources should be distributed evenly so that a certain demographic is not deprived of medical assistance and treatment. It also refers to the responsibility of healthcare professionals to adhere to legislation in their decisions. However, it can be argued that the principle of justice is not always applied in healthcare, as individuals who are of lower socioeconomic status or identify with minority races may receive unequal treatment.

The Hippocratic Oath

Another source medical practitioners use as a basis for ethics is the Hippocratic Oath. Originating from Ancient Greece, the oath emphasizes for those who swear by it to uphold ethical standards, including the popularized phrase to “first do no harm.” While many adaptations have been made, the 1964 version rewritten by Tufts University Academic Dean Louis Lasagna is used in many medical schools today. In this version, individuals swear to respect privacy, prevent disease, protect the environment, and view patients as human beings, among other criteria. The Hippocratic Oath remains a reminder in the medical community to uphold high standards of patient care and practice medicine ethically.

The study and practice of bioethics through its main principles of autonomy, non-maleficence, beneficence, and justice have improved the standards and quality of healthcare in all settings. In the next part of this Ethics in Healthcare series, we will explore how ethical issues in healthcare often arise when there is a conflict between the four principles.

12 Days of Christmas Invent

The most wonderful time of the year is officially here! You may usually count down the days until Christmas with an Advent calendar, but why not count down with an “Invent” calendar, too? Happy Holidays from the Office of Technology Transfer and these twelve days of festive inventions.

It’s beginning to look a lot like Christmas… with all of those twinkly lights strung up around the house! Would you believe that Christmas lights were actually invented by Thomas Eddison and his business partner Edward Johnson in 1882? The duo hand-wired 80 lights around Johnson’s revolving Christmas tree, but it didn’t become common practice until President Glover Cleveland requested to light the White House Christmas tree in 1895. https://www.loc.gov/everyday-mysteries/item/who-invented-electric-christmas-lights/

Let it snow, let it snow, let it snow… so you can have a chance to try out this Snowball Gun! Filed in 1947, U.S. Patent 2607333 contains a mechanism that transforms loose snow into small pellets for the best snowball fight ever. https://patents.google.com/patent/US2607333?oq=snowball

holiday graphicOn the third day of Christmas my true love gave to me…. A Santa Claus visit kit! US Patent 7258592B2 comes with everything you need to bring the magic of a visit from Santa to your kiddos on Christmas Eve–Santa sized boot stencil and all.
https://patents.google.com/patent/US7258592B2/en

You know Dasher and Dancer and Prancer and Vixen… and you know they need something to eat after flying around the world on Christmas Eve. U.S. Patent US20020128081 is a Reindeer Food Kit. https://patents.google.com/patent/US20020128081

Merry Christmas and Happy Hanukkah! U.S. Patent 20160215971A1 blends the style of a Christmas tree with a traditional Hanukkah candle holder for interfaith holiday celebrations. https://patents.google.com/patent/US20160215971

Rocking around the *artificial* Christmas tree! U.S. Patent 1654427 is a collapsible, artificial Christmas tree that probably looks similar to the one you use in your home today… even though it was filed all the way back in 1927! http://www.freepatentsonline.com/1654427.pdf

No matter what you stuff your stocking with, U.S. Patent US2536407A has got you covered! The Christmas stocking hanger is “designed for holding stockings suspended from a mantelpiece to be filled by Santa Claus on Christmas Eve.” https://patents.google.com/patent/US2536407A/en

He’s making a list, he’s checking it twice, and he’s gonna find out who’s naughty or nice… and with US Patent 20080299533A1, you can find out too! This Naughty or Nice Meter grades children on things like how well they brush their teeth and clean their room to see if they will end up with toys or coal in their stocking.
https://patents.google.com/patent/US20080299533A1/en

Take a trip down Candy Cane *history* Lane with me! Legend has it that Candy Canes were invented by a choirmaster at the Cologne Cathedral in Germany, in an effort to keep his young singers quiet during the Living Crèche ceremony. The choirmaster bent sugar sticks into shepherds’ crooks in honor of the occasion–and now the bent candies that we know and love today are the most popular holiday treat. https://www.history.com/news/candy-canes-invented-germany

Elves used to live at the North Pole, but now they live on the shelves of homes across the country. Elf on a Shelf, the Christmas staple that watches over children and reports back to Santa each night during the Holiday season, was invented by a stay-at-home mom and her two daughters back in 2005, after they themselves had used a sort of “elf on a shelf” as family tradition since the early 1970s!  https://www.huffpost.com/entry/the-elf-on-the-shelf-history_n_5a24c89be4b0a02abe920d71

This patent gives a whole new meaning to Holiday Magic! Officially called a “wand activated electric menorah,” U.S. Patent 6053622A is an innovative Menorah that is lit and extinguished with the flick of a wand. https://patents.google.com/patent/US6053622A/en

Sleigh bells ring… are you listening? U.S. Patent US5297324A, called the “fully rounded jingle bell making method,” streamlines the bell-making process so that they’re ready to ring all holiday long! https://patents.google.com/patent/US5297324A/en

Recognizing 35 U.S.C.101, 102, 103, and 112 in Jurassic Park

2020 marks the 30th Anniversary of Michael Creighton’s epic novel Jurassic Park. This book directed the trajectory of my first career as a technical research specialist and my current pursuit of intellectual property licensing professional.

First published in 1990, Creighton’s novel intercalated burgeoning genetic engineering techniques with science fiction to produce an intellectually stimulating tale respected by both scholars and Sci-Fi aficionados. The story’s premise: extinct dinosaurs are reintroduced into present-day existence using DNA extracted from fossilized material. Not surprising, the dinosaurs are unsuccessfully assimilated into a zoo-like habitat on a remote island[1]. While some (not me) have criticized Creighton for employing scientific poetic license to enhance the literary and cinematic drama of Jurassic Park, few have scrutinized the legal latitude taken within the novel. The intellectual property implications involving the fictitious R&D company, International Genetic Technologies, Inc (InGen) begs to be examined!!!

jurassic Book cover

First Edition Cover; Artist: Chip Kidd, Publisher: Alfred A. Knopf

The novel closed with InGen filing for Chapter 11 bankruptcy protection on October 5, 1989. Because cataclysmic mayhem broke out on Isla Nublar (Site 1) in August of the same year, company lawyers attempted to mitigate their losses by liquidating assets before the Park officially opened. Given this information, it is fair to hypothesize that both the technological capabilities in genetic engineering as well as U.S. laws regarding intellectual property owned or licensed by the parent company were those applicable to the mid and late1980’s.

Noteworthy legal embellishments were taken regarding InGen‘s “patented” dinosaurs. I feel it is safe to speculate that before the mythical law firm of Cowan, Swain, and Ross engaged InGen as a client, the firm would have comprehensively appraised the company’s assets and liabilities and evaluated the commercial potential of the proposed patentable technology. The Firm would have mobilized their IP Management team and probably engaged outside counsel to provide a comprehensive patentability analysis to assess among other things if the tech satisfied 35 U.S.C.101, 102, 103, and 112 requirements e.g.

  1. whether the invention created by John Hammond and Dr. Henry Wu (company chief geneticist) was patent-eligible
  2. if the technology to regenerate extinct animals from fossilized DNA could be described as useful, novel, and non-obvious
  3. whether a patent could be enforced, and if so, the potential scope of the claims, and
  4. whether the product and process of InGen would infringe the enforceable rights of a third party.

Herein lies a conundrum in the storyline and the slippery slope of subject matter eligibility.

Laws of nature, natural phenomena, and abstract ideas are patent ineligible

Creighton alludes to “patented” dinosaurs. As a U.S. company (headquartered in Palo Alto, CA), InGen would have been bound by the prevailing laws regarding patents. The Constitutional statute governing patents is codified in Sections 100 – 105 of Title 35 of the United States Code. At a minimum, a patent may be conferred to:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent, subject to the conditions and requirements of this title”[2].

Caveats to the exclusivity of patent rights is that the invention must be novel, non-obvious, and not directed toward a judicial exception i.e. laws of nature, physical phenomena, and abstract ideas.[3] With one or more patents, InGen could prevent others from making, selling, using, or manufacturing the product or process they invented.

Realistically speaking, could any of the dinosaurs regenerated from fossilized DNA in Jurassic Park skirt the law of nature judicial exception or the novelty requirement for a method of acquiring dinosaur DNA?

Yes and No!

In the 1980s, a radical change to laws governing subject matter eligibility occurred. In the strictest sense, Dr. Henry Wu’s groundbreaking work at InGen would have fallen within the realm of a judicial exception i.e., law of nature, and therefore be considered patent ineligible. But, the precedential Supreme Court decision of Diamond v. Chakrabarty, 447 U.S. 303 issued June 16th, 1980 made living, man-made micro-organisms patent eligible as a “manufacture” within the meaning of the 1952 Patent Act.[4] This decision would have given InGen counsel and executives the green light to embrace the avant-garde technique of cloning dinosaurs.

In 2013, the US Supreme Court nullified in part the range of patentable material previously allowed by Diamond v. Chakrabarty with the Molecular Pathology v. Myriad Genetics[5] ruling. But, since this would not be relevant for 24 years from InGen’s initial discovery, their right to exclusivity would have expired!

Anticipation and Obviousness

What if InGen’s “patented dinosaur” technology was a method of extracting DNA from fossilized material as opposed to the animals per se? Would the method be patent-eligible?

Yes (maybe) and No!

In the1980’s, DNA extraction was not a novel technique. Isolation of genomic DNA, plasmid DNA, and RNA, while laborious, was regularly performed. If InGen were patenting a specific method of extracting DNA from fossilized material, sequencing and aligning said DNA, supplementing un-interpretable codons with commensurate Xenopus laevis DNA sequence, using said manipulated DNA to asexually fertilize a recipient ovum, and incubating the resulting embryo in a surrogate host until parturition, that might be considered novel, un-obvious, not anticipated by the prior art and therefore patent-eligible.

Description

An issued patent on InGen’s dinosaurs would have necessitated that enough information be publically made available so that someone, skilled in the art, could make or use the invention without undue experimentation.[6] Without a detailed description, the USPTO would have rejected Ingen’s patent application with a 35 USC 112 rejection. In light of the requisite public disclosure, why would the nefarious Dennis Nedry (Park computer programmer/industrial spy) and Lewis Dodgson (unscrupulous product development chief at a rival company, Biosyn) have needed to steal the technology?[7]. We know all too well how that turned out!

Epilogue

Sharon Begley of STAT has asserted that “[d]e-extinction” efforts are on the horizon[8]. The practical utility of regenerating dinosaurs … is arguable. As of 2020, one or more of the 15 species of dinosaurs created in the original Jurassic Park could possibly be patent-eligible. An IP expert could reasonably argue that InGen’s de-extinct creatures are not exact recreations of those animals that roamed the earth 235 million years ago and represent a totally man-made manufacture. While someone “skilled in the art” could probably find the method of extracting dinosaur DNA from the blood of ancient insects preserved in amber as experimentally flawed, it still makes for a totally enjoyable story 30 years later.

— Renee Shaw

Citations:
[1] Crichton, Michael. Jurassic Park. New York: Ballantine Books, 1990.
[2] USPTO https://www.uspto.gov/about-us/news-updates/us-patent-system-celebrates-212-years via @USPTO
>[3]</sup https://en.wikipedia.org/wiki/United_States_patent_law
[4] Diamond, v. Chakrabarty, PhD 447 U.S. 303 (1980) Supreme Court Decided June 16th, 1980 Citations: 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144, 1980 U.S. LEXIS 112
[5] U.S. Supreme Court,
ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL. v. MYRIAD GENETICS, INC., ET AL. 12-398
[6] MPEP
[7] “The Science of Jurassic Park and the Lost World” by Rob DeSalle and David Lindley; 1997; Basic Books publisher
[8] Scientists Have Reconstructed the Genome of a Bird Extinct for 700 Years
By Sharon Begley, STAT on February 27, 2018

What is the Flu-shot and Why isn’t it 100% Effective?

Influenza is a contagious respiratory infection that comes in a variety of versions or strains. These strains can change on an annual basis and the flu shot will protect users to up to three to four strains. Symptoms of the influenza, also known as the flu, can range from mild to severe depending on the individual. Moreover, the flu is known to target certain populations in greater severity than others, such as those who have a weak immune system, chronic conditions, the elderly population, or even younger children.

The flu-shot, also known as, the influenza vaccine is a seasonal injection given during the fall period. This vaccination helps to protect the body against the top three to four influenza virus strains most commonly circulating during that season.

What composes a vaccine aside from the inactive form of the virus itself, is inert (chemically inactive) ingredients. In fact, many vaccines can have inert ingredients. Types of ingredients that can be found in a flu vaccine are: preservatives, aluminum salts, sugars/gelatin, residual antibiotics etc. It is also important to remember, the flu vaccine itself will be providing patients with a “dead” form of the virus. In contrast, in the nasal spray is another form of drug administration in which the virus is “live” but in a weakened state.

Today, the flu vaccination is categorized as a public health intervention. Due to this, the Centers for Disease Control and Prevention (CDC) will complete annual studies with various hospitals and universities to determine the effectiveness of the flu vaccine. Herein lies the question, why is the flu vaccine not 100% effective each year? Typically, the flu-shot will act as 40-60% effective. The process of obtaining the flu vaccine begins with over one-hundred international and national influenza centers collaborating in a surveillance effort for which versions of influenza that are the most prominent. This data is collected and with the help of the World Health Organization (WHO) specifically. Subsequently, specific strains are chosen for that year as the most popular. Thus, with all the research, data, and group efforts to predict and perfectly align the virus strains sometimes a poor match can be made, and a different version of influenza will end up predominantly circulating in the fall in certain areas.

In conclusion, with support from multiple studies, the FDA, WHO, and CDC, the flu vaccination has been shown to have significant protective characteristics to the general population. Therefore, it is important we all take the steps to ensure the safety in our health and the health of others by obtaining a flu-shot during this season!

Resources:
https://www.cdc.gov/flu/prevent/flushot.htm
https://www.cdc.gov/vaccines/vac-gen/additives.htm
https://www.cdc.gov/flu/about/viruses/types.htm
https://www.mayoclinic.org/diseases-conditions/flu/in-depth/flu-shots/art-20048000

 

The Patents of Thanksgiving

Creativity and inventiveness don’t stop because it’s mealtime. As many patents show, there are always problems to be solved, regardless of how big or small the issue is. In this season of Thanksgiving, we want to say thanks to the inventors and patent holders of intellectual property that has made Thanksgiving better, easier, or just more interesting… read to find out more about 6 patents that can help you have a fantastic Thanksgiving from start to finish!

“Cranberry harvesting method and apparatus”
Ever wondered about how cranberries move from the field to your table? If so, then U.S. Patent #5375402 is for you. Called the Cranberry harvesting method and apparatus, the patent includes a “frame movable through a field of plants, a revolvable surface carried by the movable structure and supported to revolve about a horizontal axis, and resilient, rubbery fingers mounted rigidly on the revolvable surface and projecting outwardly therefrom.”Happy Harvesting!

Cranberry harvesting method and apparatus patent graphic

“Animated wildfowl decoy”
While harvesting cranberries is one way to put Thanksgiving dinner on the table, some of you may prefer to play a more active role in acquiring your Thanksgiving delicacy. If you plan to go hunting for fresh meat on Thanksgiving, you may want to check out U.S. Patent #5289654, described as “an animated decoy simulating the external appearance and certain head and neck movements of a wild turkey.” Essentially hollow, the animated turkey neck includes interconnected, longitudinal segments.

Animated wildfowl decoy patent graphic

“Disposable cooking pan”
After using the Animated Wildfowl Decory and Cranberry Harvesting Method and Apparatus—or just heading out to the grocery store—you’ve gathered up all of your ingredients for a delicious Thanksgiving meal. Next up, you’ll need cooking supplies, and U.S. Patent #5628427 has got you covered. You’ve probably used this disposable cooking pan a time or two, and it’s easy-to-use, “single sheet of metal” design with a bottom panel, continuous wall panel, and continuous rim are perfect for cooking up a Thanksgiving treat!

Disposable cooking pan patent graphic

“Cooking jacket”
If you want to keep your turkey comfortable and stylish while it cooks, be sure to dress it with U.S. Patent #4942809. Actually, this fashionable finery for our formerly feathery friend is to make lifting it out of the pan less difficult. Used for cooking large pieces of meat, the cooking jacket “enables turkey or other pieces of meat to be retained in a jacket structure and easily lifted from the cooking pan, pot, vessel or the like.”

Cooking jacket patent graphic

“Turkey baster”
After all of your hard work preparing your feast, you’ll certainly want to make sure that your turkey doesn’t go dry! You can keep it juicy and flavorful with U.S. Patent #D390070, known as the turkey baster.

Turkey baster patent graphic

“Method and apparatus for molding fruits”
Let’s say that, sadly, Aunt Gertrude is unable to make it this year. No worries! With enough notice, you can use U.S. Patent #4827666, designed for “growing squash, cucumbers and other fruits in desired shapes.” It can even create “long-lasting sculptural items!” Use U.S. Patent #4827666 to create a sculpture of Aunt Gertrude and it’ll be like she’s with you the entire meal…until you finish eating.

Method and apparatus for molding fruits patent graphic

Happy Thanksgiving!

What is PHI?

PHI stands for Protected Health Information and encompasses all information acquired during health care services that could potentially be used to identify an individual. PHI does not only include medical records, but also communications between medical personnel regarding treatment, billing information and health insurance reports.

For information to be formally considered PHI under the law, it must be created, received, stored, or transmitted by HIPAA-covered entities. Under the Health Insurance Portability and Accountability Act (HIPAA), covered entities are limited in the types of PHI they can collect from individuals, share with other organizations or use in marketing. HIPAA-covered entities include healthcare providers, insurance providers, healthcare clearinghouses and their business associates who have access to PHI. These entities must implement guidelines to protect against the unauthorized disclosure or destruction of PHI as required by the HIPAA Privacy Rule.

PHI is also a commodity and is valuable to clinical and scientific researchers when anonymized, as it can be used observational studies. However, PHI can be very attractive for hackers, since it can be illegally sold online or targeted as part of a ransomware attack.

PHI does not include education record information or data used by healthcare entities in their role as employers. In total, there are 18 unique identifiers considered to be PHI:  (For more information on the 18 identifiers visit: https://www.hipaajournal.com/what-does-phi-stand-for/)

  • Names
  • Geographic data
  • All elements of dates
  • Telephone numbers
  • FAX numbers
  • Email Addresses
  • Social Security Numbers
  • Medical record Numbers
  • Health plan beneficiary numbers
  • Account numbers
  • Certificate/ license numbers
  • Vehicle identifies and serious numbers including license plates
  • Device identifiers and serial numbers
  • Web URLs
  • Internet protocol addresses
  • Biometric identifiers (e.g. retinal scan, fingerprints)
  • Full face photos and comparable images
  • Any unique identifying number, characteristic, or code

The Immunization Supply Chain and How COVID-19 Presents New Challenges

As the world races to develop a vaccine to combat the COVID-19 pandemic, many look towards a future of inoculation. To reach this goal, there are challenges that come with the research and creation of a vaccine that must be overcome. However, the creation of a vaccine is only the first step. The manufacturing, distribution, and packaging of vaccines are also extremely important. Vaccine supply chains are what society leans on for vaccination distribution that is safe, efficient, and fair. This is part of the process that isn’t particularly visible to the public and many people may not consider or know much about.

The goal of supply chains is to maintain the availability of quality vaccines from the manufacturer level to the service delivery level. Vaccine management and logistics support are crucial to the success of a supply chain at every level of distribution. Vaccine management and logistics support focuses on vaccine monitoring, cold chain management, immunization safety, and global shipping.

Cold chain management is especially important in the vaccine supply chain. Scientists have identified that 2°C to 8°C is the optimal temperature for vaccine storage and that these conditions must be maintained from manufacturing through the immunization of a patient. WHO estimates that typically around half of produced vaccines are wasted each year due to inadequate temperature control in supply chains.

Vaccine waste is a combination of discarded, lost, damaged, and destroyed vaccines. Vaccine waste accounts for a significant portion of the costs in the supply chain, so minimization of waste is a priority, particularly now with such vast quantities needed. Calculating the waste rate is important for preventing under or over-stock and allows the adjustment of supply chain infrastructure at a national level. On a global scale, waste helps forecast vaccine access.

In addition to the existing challenges of the supply chain, the current COVID-19 pandemic presents new barriers to overcome. One such barrier lies with the production of medical products like vials and syringes necessary for inoculation at such a scale. In the United States alone, there is a demand for at least as many vials and syringes as the 300 million people that may need to be inoculated. To adjust for this scale of demand, production companies will have to ramp up manufacturing or find alternatives. The pandemic has resulted in industry-wide delays in inventory replenishment for many products, which may hinder the capacity of production companies to meet such a large demand for the products necessary to manufacture and distribute a vaccine.

Another challenge that the pandemic presents is global distribution through ships, planes, and trucks. Freight companies have already been stretched thin by the pandemic and face shrinking capacity on their cargo ships and planes. The stopage of commercial flights has added to the supply shortage since they usually carry cargo below the passenger cabin. Distributing the vaccine to rural and remote communities also presents challenges, and logistical services will be stretched to reach these communities.

The accelerated production of a COVID-19 vaccine may also lead to changes, hopefully improvements that can be applied elsewhere, in vaccine production and distribution. The surge in investment in vaccine development due to COVID-19 may bring new players to the market or put additional pressure on competition and profit margins.

The challenges of the manufacture and distribution of vaccines as well as the supply chain will be the next hurdle to overcome after the development of a successful vaccine, or maybe more than one. Being able to exit the current pandemic will also rest on manufacture and distribution and on the world’s preparedness and willingness to combat these challenges head-on.

Resources:
WHO: https://www.who.int/immunization/programmes_systems/supply_chain/en/
Forbes: https://www.forbes.com/sites/sap/2020/08/27/the-next-supply-chain-challenge-how-to-vaccinate-the-world/#73b91f727c4f
https://www.forbes.com/sites/willhorton1/2020/04/01/7-unusual-ways-aircraft-now-fly-cargo-during-coronavirus-outbreak/#5f844fa635b1
NY Times: https://www.nytimes.com/2020/05/01/health/coronavirus-vaccine-supplies.html
S&P Global: https://www.spglobal.com/ratings/en/research/articles/200803-covid-19-may-accelerate-disruption-in-the-global-vaccine-market-11568238

Coronaviruses: New to Humanity but Not New to The World

Although many of us might not have heard of coronaviruses before 2019, these viruses are not new to the world. They belong to a large family of hundreds of viruses that have been on scientist’s radar for a long time. Most of these viruses reside in animal reservoirs like pigs, camels, bats, or cats. Despite the world’s familiarity with different types of coronaviruses, COVID-19 is known as a “novel” coronavirus. This means that, although this virus has existed in animals for some time, it has only recently been identified through an animal-to-human transition.

All coronaviruses are separated by scientists into four distinct groups: alpha, beta, gamma, and delta coronaviruses. Only seven alpha and beta coronaviruses are known to infect humans. Scientists have named these viruses:

  • 229E (alpha coronavirus)

  • NL63 (alpha coronavirus)

  • OC43 (beta coronavirus)

  • HKU1 (beta coronavirus)

  • MERS-CoV (beta coronavirus that causes MERS)

  • SARS- CoV (beta coronavirus that causes SARS)

  • SARS-CoV-2 (novel coronavirus that causes COVID-19)

Of these seven, four of the viruses are reported to cause mild to moderate symptoms and three are associated with serious diseases. The first identified coronaviruses were recorded in the mid 1960s, but are believed to have circulated in human systems for centuries. These include 229E (alpha coronavirus), NL63 (alpha coronavirus), OC43 (beta coronavirus), and HKU1 (beta coronavirus). This group of viruses are known to present only mild respiratory infection, though HKU1 is associated with gastrointestinal infection as well.

The three viruses known to lead to potentially fatal diseases are SARS-CoV, MERS-CoV, and SARS-CoV-2. SARS-CoV is known to cause severe acute respiratory syndrome (SARS), and the virus infected a total of 8,098 individuals during the outbreak of 2003. MERS-CoV causes Middle East respiratory syndrome (MERS), and the 2012 outbreak continues to infect dozens of people annually. SARS-CoV-2 causes the coronavirus disease the world is currently dealing with in the COVID-19 pandemic.

Just as MERS was transmitted to humans from the animal reservoir camels, COVID-19 is believed to have similarly originated from an animal reservoir, though specifically which one is still being studied. This “jump” of a virus from an animal reservoir to humans is called a spillover event. A spillover event can occur either through a mutation directly to humans or through an intermediary species that mutates the virus into a human pathogen.

Although the family of coronaviruses has been around for some time, there is still much to learn about this new novel coronavirus. This global pandemic has proven to infectious disease researchers that there is still much to be learned about spillover events in order to better equip society to handle possible animal-to-human transmissions from viruses in the future.

Resources:
Cleveland Clinic: https://consultqd.clevelandclinic.org/coronaviruses-have-been-around-for-centuries-what-differentiates-2019-ncov/
National Institute of Allergy and Infectious Disease:
https://www.niaid.nih.gov/diseases-conditions/coronaviruses
WebMD: https://www.webmd.com/lung/coronavirus-strains#1

No Need to Learn Latin! Understanding In Vivo, In Vitro, and Ex Vivo Techniques

In vitro fertilization, ex vivo gene therapy, and in vivo clinical trials are exciting techniques in the medical field. The words that describe these methods (in vitro, in vivo, and ex vivo) are common adjectives used to describe research, treatments, or procedures. Although these words sound similar, they are distinct from each other and have unique uses and advantages. Let’s explore the meanings and uses of in vitro, in vivo, and ex vivo techniques.

In Vivo
In vivo describes when a study is done inside a living organism, such as a human or animal. In vivo is Latin for “within the living”. Clinical trials for medicines are often done in vivo because the conditions of a living organism cannot be replicated outside the body. Usually, in vivo treatments are tested on animals first, such as mice or rabbits, and if they produce the desired effects, clinical trials then open to humans. One advantage of in vivo clinical trials is that it shows the entire body’s response to a treatment or drug, including how the drug is metabolized by the body and the body’s response to the drug or treatment.

In Vitro
In vitro is Latin for “in glass”: it describes treatments that are done in a controlled environment such as a test tube or petri dish. The growth of cells, tissues, or bacteria that are in vitro is called a culture. Cultures are used extensively in the early stages of research because testing the responses of cells or tissues is much easier when they are isolated in a culture. Cultures can be easily replicated which is much cheaper than paying for living subjects to participate in an in vivo clinical trial! However, in vitro testing is mostly done in early stages of research because conditions in a petri dish or glass tube cannot show the effects of treatment on the entire body.

In vitro fertilization
In vitro fertilization (IVF) is a fertility treatment consists of extracting one or more eggs from a woman’s ovary and putting them into a petri dish with a man’s sperm. The dish is left in a controlled environment for three to five days, and then the fertilized egg is inserted into the woman’s uterus. She can then carry the embryo to full term within her body. IVF has helped women and men who struggle with fertility to have children with the assistance of a controlled environment outside the body, which is a great example of the advantages of in vitro treatments.

Ex Vivo
Ex vivo treatments combine elements of in vivo and in vitro to advance the boundaries of medical treatments and therapies. Ex vivo is Latin for “from life”: it involves cells or tissues taken from a living organism, such as a human or animal, and transports them into an artificial environment with very similar conditions. The new environment is as similar as possible to the body where the cells and tissues were extracted from so that they can later be implanted back into the body! An advantage of ex vivo treatments is that they provide conditions similar to in vivo experiments while benefiting from the isolation that in vitro methods have.

Ex vivo gene therapy
A revolutionary use of ex vivo methods is in the field of gene therapy, which prevents or treats disease by introducing new DNA into cells. Gene therapy is needed when the body has a defective gene and can’t produce necessary proteins. In ex vivo gene therapy, cells are taken from the body and exposed to a virus in an artificial environment. The virus inserts the gene into the cell’s DNA and the cell with the functioning gene is injected or transplanted back into the body. Ex vivo gene therapy has treated genetic conditions such as hemophilia and is being studied in clinical trials to determine whether it can be used to treat acquired diseases such as cancer.

In vivo, in vitro, and ex vivo describe the methods used for research and treatment and they differ in whether they take place inside the body or in a controlled environment such as a petri dish or test tube. The words may be in a different language but you don’t need to be an expert in Latin to understand how these methods are used to test new drugs and improve medical treatments!

References
https://www.healthline.com/health/in-vivo-vs-in-vitro
https://www.verywellhealth.com/what-does-in-vivo-and-in-vitro-mean-2249118