Do no harm” is the phrase people most associate with the Hippocratic Oath, but nowhere does the document say these exact words (“never do harm” is what it actually says [1]).

The Hippocratic Oath is the vow medical students take during their white coat ceremony at the beginning of medical training and again at graduation, proclaiming their commitment to medical ethics. The original oath has been modified multiple times in medicine’s history, but three versions are most commonly recited today. They are:

  • The original 5th-century-B.C. Oath of Hippocrates provided the first ethical guideline for physicians in ancient Greece.
  • The Declaration of Geneva was written in 1948 (amended numerous times, most recently in 2017) in response to the grotesquely inhumane treatment of individuals in Nazi Germany
  • The Modern Physician’s Oath is a 1964 revision by Dr. Louis Lasagna.

New versions of the Hippocratic Oath are increasingly vague

With each new version, however, the oath has grown increasingly vague to accommodate changing values within societies.

The 5th-century-B.C. oath proclaims, for example, “To please no one will I prescribe a deadly drug.” And later, “Nor will I give a woman a pessary to procure abortion.” These two issues are highly relevant in modern times. Physician-assisted suicide, over-prescription of opioids, and abortion are among other topics of debate and controversy today.

The first Declaration of Geneva kept the pledge to “maintain the utmost respect for human life from the time of conception.” However, there is no mention of physician-assisted suicide, euthanasia, or any deadly drug. 

The closest the younger Lasagna oath comes to addressing these controversial topics is when it vaguely notes, “I tread with care in matters of life and death. If it is given to me to save a life, all thanks. But it may also be within my power to take a life.”

The 2017 version of the Declaration of Geneva simply says, “I will maintain the utmost respect for human life,” on the matters of life and death.

Is it ethical to change the oath?

Though revisions to the original oath have diluted specific vows, many updates to the Hippocratic Oath have been useful and productive. Among them are these:

  • Simplifying the language
  • Taking out prayers of fidelity to the Greek gods and goddesses of health care
  • Adding a pledge to care for a physician’s own health are indisputably positive changes

But as the oath becomes more ambiguous, it’s natural to question the ethics of altering moral standards of medicine. Is it ethical to change the Hippocratic Oath to accommodate an ever-changing society?

Yes, according to Joseph Carrese [2] MD, MPH, FACP, chair of the Johns Hopkins Ethics Committee and professor of medicine at the Berman Institute of Bioethics. “Not only do I think it’s ethical to change the oath, I think there’s a strong argument for doing so.” Carrese explains that he doesn’t believe a document written thousands of years ago in a different historical and cultural context should strictly apply to every person, for all time, in all situations.

The original oath also fails to address modern concerns, he adds, such as the importance of working with patients as equals and the right for patients to make their own health care decisions. It even warns against using a knife in certain circumstances—particularly to remove kidney stones [3]—which limits the practice of surgery. Carrese notes that as time passes and physicians learn more about medicine, it is reasonable to revise the ethical guideline.

Some newcomers to the profession agree. Ian Coblentz [4], MD, an intern at UC San Diego Medical Center, explains that the original oath protects against procedures that, in the 5th-century-B.C., were extremely painful and risky due to a lack of technology. But now, doctors perform those procedures frequently with very little danger. “I don’t think [the authors of the oath] had an idea of how modern surgery could be,” Coblentz says. “So I think we do have to adapt the oath and the ethical principles we write into it for the technologies and the techniques we have in the modern-day.”

Personalized Vows

There has even been a recent trend in medical schools for students to work together to write their own[5] oath as a class. Medical schools like Harvard, Yale, and the University of Texas have allowed students to ditch the oaths of the past and write a pledge that holds true to their values, such as incorporating God into their vows and respecting patients of any sexual orientation.

UC San Diego’s med students recite a modern version of the Oath of Hippocrates, but if given the chance to write his own, Coblentz says he wouldn’t have changed much about the version he took. As long as certain basic principles of the oath remain, such as doing good for the patient and treating everyone equally, Coblentz believes there’s room for a diversity of oaths.

But medical student Benjamin Frush, at the University of North Carolina School of Medicine, is not so convinced that customized oaths are a good idea. In “The Hippocratic Oath and the Contemporary Medical Student[6], published in Academic Medicine and co-authored by fellow med students at the University of North Carolina, Frush and his colleagues write, “Such a practice contradicts the purpose of an oath, which draws its adherence into a community and acknowledges the presence of an authority greater than the oath-takers themselves.”

Frush goes on to say that although the original words of the 5th-century-B.C. Oath of Hippocrates may make it difficult for physicians today to endorse in good faith, “modern versions [that] still contain the ethos of the Oath—namely, the calling towards an objective view of good medicine—exist and should be recited rather than individual oaths.”

RELATED: The Ethical Stain on U.S. Medical Care

The oath is a public proclamation about a commitment to medicine

What’s important to Carrese, though, is not the specifics of what students recite, but that they take an oath at all, making a public proclamation about their commitment to the medical profession. Declaring the duties and values of the profession in front of the public, as well as friends and family, is highly valuable, Carrese says, because the medical profession is a public trust. “We exist in a contract or covenant with society—society allows us to exist as a profession and gives us certain privileges, and we need to fulfill certain commitments to retain those privileges and continue to exist as a profession.” The oath is a way for doctors to do that.

The dedication and sense of moral obligation that the oath represents are what Carrese, Frush, and Coblentz all seem to believe make it worth reciting. What’s also important to Coblentz is the promise his teachers made to him, his classmates, and future generations of doctors when his teachers took the oath many years ago. “As a student,” explains Coblentz, “it [was] affirming for me to hold my teachers accountable: ‘This is how you should teach me, as part of this family, as part of this profession.’”

Which moral standard is best?

“Creating one’s own standards of success suggests that good medicine is [equivalent] to personal preference, which the Oath . . . strongly argues against,” Frush notes. If medical vows differ nearly from doctor to doctor then, how can physicians and patients determine which moral standard is best?

“I’m not somebody who believes strongly that one size fits all,” Carrese explains. “And when I say that, I’m thinking about the tremendous cultural and religious diversity we have, not only in this country but of course the world.” The values and traditions of one cultural group, Carrese continues, may not apply to another group in the same way, and his view is that doctors should be flexible about how to manage patients. That is, at least, as long as physicians are avoiding human rights violations.

RELATED: Medical Ethics and the Impact of Technology

With differing worldviews come conflicting viewpoints, such as how to approach controversial topics like those mentioned earlier. For this reason, Carrese believes the oath should only address basic morals that virtually everyone agrees on. And they should avoid polarizing statements regarding physician-assisted suicide, abortion, or any other controversial subject. “Most people would agree, however,” Carrese concludes, “that a good starting point for any moral system or any moral code is the notion of respect, and the right to be self-determined, however the patient defines that.”

The original intent of the Hippocratic Oath

Luis Vera [7], PhD, who teaches ethics at Mount St. Mary’s University in Maryland, suggests something else. He says that an oath proclaiming a definitive stance, even in the face of controversy, is what the original authors intended. “We could easily assume that [the original oath] is enshrining values of its own culture,” Vera explains. “But that’s actually not true at all.”

The Oath of Hippocrates was written by a group of Pythagoreans [8]. They were a minority of Greek thinkers who followed the Pythagoras philosophy which encompassed a broad range of metaphysical and mathematical ideas. This was at a time when there was disagreement among society about abortion, suicide, even patient-doctor confidentiality.

“[The authors] understood themselves to be reformers[9]—they thought they were reforming the practice of medicine in a society that did not agree on these things,” Vera explains, referencing Allen Verhey’s writing in On Moral Medicine.[10] “The oath for them was setting out a particular view of what medicine was about.”

For Vera, the question of whether to change the oath, then, first comes down to the ethics surrounding these highly contested issues. “The right thing to do, I think, is to put that question off to the side for a little bit and for us to sort out some of these ethical issues. Conversations about abortion, physician-assisted death. They matter in themselves and it is good for us, as a society, to keep having those conversations in the most honest, civil, well-intentioned, and charitable way possible . . . which is already hard to do, right?” Vera says with a lighthearted laugh, before adding that there is likely no single solution that will completely resolve these debates.

 Defining the field of medicine

Additionally, Vera believes that, not unlike the Pythagoreans, it’s necessary for 21st-century doctors to clearly define what the field of medicine is meant to accomplish. Is medicine a robust, fruitful practice with internal goods—satisfying and excellent for its own sake with morality intrinsic to it? Or is it a consumer service—technical skills provided for a patient to fix their body and alleviate or prevent suffering?

Though he doesn’t put much stock in the latter view, Vera says there’s something to be said for it. “If we can make the patient’s autonomy the sole ethical criteria for good medicine,” he explains, “then we don’t have to sort out a lot of other [controversial topics], so it seems really convenient.”

Still, many bioethicists, Vera says, worry that viewing medicine solely as a consumer service could lead to unwanted consequences:

“If we really make patient autonomy the only deciding factor for the ethics of medicine, we are slouching toward the point where we can’t say that elective amputations of otherwise healthy limbs. . . . are any different than amputating a gangrenous leg.”

Therefore, Vera believes that medicine today must be a mix of both: a passionate commitment to the good of health, and a consumer service.

Related Content: Preventing Amputations: Saving Lives and Limbs

Protecting Basic Morals

So with differing versions of medical oaths, values, and ideas about the purpose of medicine, how can doctors and patients protect basic morals so that necessary ethical lines won’t disappear in the future? According to Vera, one important task for protecting moral boundaries is to keep asking ethical questions about the practice of medicine.

“It’s good for each generation of doctors to think deeply about the meaning of what they’re doing,” he says. “That’s a sign of a healthy, developing tradition—when each new generation not only receives the inheritance behind it but adds to it.”

When examining how the Hippocratic Oath has changed, it’s understandable, Vera adds, to question where the practice of medicine might lead—where ethical clarity ends and murky human error begins. We should respond to change, Vera urges, as an opportunity to openly and honestly discuss the purpose of the medical practice and what we hope for the future of our society.

#

**Love our content? Want more information on Medical Ethics, Philosophy, and Physician Standards?  SIGN UP FOR OUR WEEKLY NEWSLETTER HERE**

#

References


[1]Physician Oaths. Association of American Physicians and Surgeons. Retrieved from: httpss://www.aapsonline.org/ethics/oaths.htm

 [2] Joseph Carrese, MD, MPH, FACP. Chair of JHBMC Ethics Committee; Professor of Medicine, Johns Hopkins University. Phone interview, 10/18/2018 & 11/09/2018.

[3] Askitopoulou, H., & Vgontzas, A. N. (2018). The relevance of the Hippocratic Oath to the ethical and moral values of contemporary medicine. Parts I & II: interpretation of the Hippocratic Oath—today’s perspective. European Spine Journal. 27 (7). 1481–1490. Retrieved from: https://link.springer.com/article/10.1007/s00586-018-5615-z

[4] Ian Coblentz, MD. University of California San Diego Medical Center. Phone interview, 11/11/2018

[5] Weiner, S. (2018). The solemn truth about medical oaths. Association of American Medical Colleges. Retrieved from: https://news.aamc.org/medical-education/article/solemn-truth-about-medical-oaths/

[6] Frush, B. W., Eberly Jr., J. B., & Gross, C. R. (2018). The Hippocratic Oath and the contemporary medical student. Academic Medicine. 93 (5). 671. Retrieved from: https://journals.lww.com/academicmedicine/Fulltext/2018/05000/The_Hippocratic_Oath_and_the_Contemporary_Medical.2.aspx

[7] Luis Vera, PhD. Assistant Professor of Theology/Ethics, Mount St. Mary’s University, Maryland. In-person interview, 11/12/2018. Email exchange, 04/25/2019.

[8] Pythagoreanism. The Basics of Philosophy. Retrieved from: https://www.philosophybasics.com/movements_pythagoreanism.html

[9] Edelstein, L. (1967). The Hippocratic Oath: Text, translation, and interpretation. Ancient Medicine. 3–63. Retrieved from: https://books.google.com/books?hl=en&lr=&id=tkVpf1ofmfEC&oi=fnd&pg=PA3&dq=The+Hippocratic+Oath,+Text,+Translation+and+Interpretation&ots=Wj-nZsnpE4&sig=FXF0wNWYJVjCUyEob56Iof9N-nY#v=onepage&q=The%20Hippocratic%20Oath%2C%20Text%2C%20Translation%20and%20Interpretation&f=false

[10] Verhey, A. (1998). The doctor’s oath—and a Christian swearing it. On Moral Medicine: Theological Perspectives in Medical Ethics. 108–119.

No, this is not a story about a holdup. Or maybe it is. It is, after all, about the high cost of life-saving drugs.

A group of about 120 leading hematology-oncology specialists from 15 countries in 5 continents published an article in the journal Blood on April 15, 2013. It is titled “Price of drugs for chronic myeloid leukemia (CML), reflections of the unsustainable cancer drug prices: the perspective of CML experts.

As Andrew Pollack reported in the NYT on April 25, 2013:

“The doctors and researchers, who specialize in the potentially deadly blood cancer known as chronic myeloid leukemia, contend in a commentary published online by a medical journal Thursday that the prices of drugs used to treat that disease are astronomical, unsustainable and perhaps even immoral. 

They suggested that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking up the prices of essential goods after a natural disaster”

Strong words indeed, coming from physicians and researchers not known for inflammatory statements. These are people who are in the trenches, daily bearing witness to the tragedy of patients pushed to bankruptcy in order to buy the medicine that will keep them alive.

The high cost of drugs: The Gleevec story

Gleevec is a drug used to treat Chronic Myelogenous Leukemia (CML), a blood cancer. The history of its discovery is instructive.

White cells in CML have an extra long chromosome, called the Philadelphia chromosome, which is a result of translocation of a piece of DNA from one chromosome to another.

This mutation causes the enzyme (a tyrosine kinase called BCR-ABL) to become permanently switched to the ‘on’ position. BCR-ABL is part of the cascade of signals that instruct a cell to divide. The result is uncontrolled cell division. This, of course, is the definition of cancer.

Dr. Brian Druker of Oregon Health & Science University toiled in his lab for many years studying the role of this key enzyme in the pathogenesis of CML.

His work was funded by grants from NIH, NCI, and the Leukemia Society. It resulted in the synthesis of a molecule that inhibited the “switched on” enzyme and cured mice that served as a model for CML.

The miracle drug

Armed with this data, Druker approached Nicholas Lydon, a biochemist at Novartis and persuaded him to test molecules from his company’s library of compounds. After several iterations imatinib was born. The compound was eventually given the brand name of Gleevec. 

The results of small Phase 1 and Phase 2 trials were astounding. The Philadelphia chromosome completely disappeared in over 80% of patients’ cells.

Time magazine promptly put Gleevac on its cover with the moniker ‘miracle drug’.

ADD_THIS_TEXT
 

Indeed, Gleevec is the first example of a rational drug design, where the target’s structure is known and a drug is then designed to inhibit its activity by binding to it.

The abject immorality of profiteering

So what is the good doctors’ problem? They couched their paper in economic terms: the drug is outrageously expensive.

Gleevac, and drugs like it, are going to bankrupt us all – not just the patients – because in the last analysis, we are all paying.

But there is another aspect to the oncologists’ rage. They call it profiteering. This term connotes economic wrongdoing, which it is, but really doesn’t capture the abject immorality of pricing these types of drugs out of the reach of the people who desperately need them.

Novartis argues that few patients actually pay the full cost of the drug. They also say that prices reflect the high cost of research and the value of a drug to patients. But, as we noted above, the main funding sources for Druker’s research was the government and non-profit organizations.

Related content:
Drug Rebates: New Executive Order Only Addresses Part of the Problem
The Crazy Way Drugs are Priced and What Can Be Done About It

Drug development costs vs the high cost of drugs

The initial clinical trials were minuscule (about 100 patients) because of the excellent results the drug showed. The FDA approved the drug in a few months. This was a record time.

Further, if we allow the high estimate of $30,000 per patient in the trial, we arrive at the relatively measly sum of $3 million. This is a far cry from the $1 billion and 20 years that the industry claims that it costs to develop a typical drug.

And, what is the company making on this drug? In 2012 the company had sales of $4.8 billion out of a total market of $7 billion for CML. How did Novartis manage to make so much money despite increasing competition from new drugs?

They did it by jacking up the annual cost of the drug. Prices went from $30,000 when it was introduced in 2001 to over $100,000 in 2013 when this article was first published.

Without ascribing unethical or immoral motives let me just point out that the patent for Gleevec was due to run out in 2016. Novartis simply acted the way economists would advise it to do: squeeze out as much profit as possible while the going was good.

What happened when the patent ran out?

On Feb. 1, 2016, Sun Pharmaceutical Industries Ltd. — based in Mumbai, India — launched generic imatinib. This heralded a new chapter in the story of targeted therapy for CML and related conditions.

At the time, a one-year supply of 400 mg imatinib pills (the standard dose for chronic phase CML) cost roughly $120,000 per year. The expectation was that the introduction of the generic drug would precipitate a sharp drop in the cost of imatinib.

A study published in May 2018 in Health Affairs tells us that this did not happen as expected: the price of the generic version only declined by 10% in the 20 months after its introduction on the market.

As the authors note:

“The case of generic imatinib demonstrates several potential barriers to effective generic price competition for specialty prescription drugs, including

  • fewer market entrants,
  • smaller-than-expected price reductions,
  • shifts in prescribing toward more expensive brand-name treatments, and
  • limited uptake of the generic product”.

Isn’t competition supposed to lower prices?

How could that be? Competition is supposed to lower prices, right? I leave this to the health economists but here is an interesting tidbit to chew on.  The prices of new branded tyrosine kinase inhibitor drugs are even higher than Gleevac!

Is there a tacit, if not overt, “understanding” to keep prices up? Again, I am straying into fields beyond my pay grade.

But you don’t have to get a degree in ethics or moral philosophy to realize that there is something profoundly wrong with charging whatever the traffic will bear when the alternative is certain death.

Such a stark choice happens in armed holdups or with Mafia-like offers that you can’t refuse.

Do people really die because they can’t afford the drug?

In reality, do people really die because they can’t afford the drug?

It turns out that the mortality from CML in the U.S is higher than expected if Gleevec were taken in the recommended doses. The suspicion is that patients are skipping doses to save money.

In developing countries, patients can’t even dream of buying this drug. There, physicians perform bone marrow transplants instead. The mortality rates from the procedure approach 50%.

Final thoughts on the high cost of drugs

Free-market ideologues never tire of quoting Adam Smith and the invisible hand.

What they are missing is that Adam Smith was not an economist. He was a moral philosopher. And, he was grappling with the dilemma of harnessing economics in the service of humanity, not vice versa.

This moral person would probably turn in his grave had he seen the extreme perversion of his writings.


Originally published on April 25, 2013, this post has been revised and updated by the author. It is, unfortunately just as relevant today as when it was first written almost six years ago. 

Ethics have always been an integral part of healthcare. Modern technological advances, however, have sometimes blurred the line between medical ethics and quality care.

These days, patients often feel like a commodity or customer instead of a “patient.” This further complicates modern medical ethics. Additionally, many medical situations have recently come under fire where ethics are concerned, including clinical trials and electronic health records.

But there is an upside. Thanks to recent advances in medical ethics, we’re likely to see an increase in social workers as part of the patient experience in both rural and urban settings. Also, taking a holistic approach to healthcare remains an important consideration in 2019 and beyond.

The Social Implications of Medical Ethics

Holistic treatment methods have entered the mainstream en masse in recent years, expanding the healthcare industry as a whole. Primary caregivers may work in tandem with social workers, nurses, and other professionals in order to treat their patients.

And, of course, ethical considerations often come into play in the realm of social work. According to professionals at Regis College, the “conflicting obligations” of social workers, such as patient confidentiality, can lead to challenging decisions.

Because of those potential conflicts, social workers must adhere to the code of ethics laid out by the National Association of Social Workers (NASW). The NASW ethics code is comprehensive, covering a variety of situations that a social worker might face.

The core principles of the NASW code of ethics include

  • social justice,
  • service, and
  • integrity.

Further, the code encourages social workers to volunteer some of their time on a pro bono basis. They are also advised to ensure that patients are treated with dignity and respect.

STDs, STIs, and Medical Ethics

Treating patients with dignity should be a best practice for every healthcare provider. However, it’s imperative in the realm of sexually transmitted disease (STD) testing. By fostering open communication and employing professional conduct, healthcare providers can help eliminate the taboos associated with STD and sexually transmitted infection (STI) testing.

It’s recommended that patients get tested for STDs on a regular basis if they are sexually active, even if they have no visible symptoms. Healthcare providers should encourage this practice by helping their patients feel at ease and by answering questions honestly.

Getting STDs and/or STIs testing takes courage. Patients of all ages are more likely to get tested when they feel that their healthcare provider is discreet and trustworthy. No matter the reason for a patient’s visit, a healthcare provider should always inquire about the patient’s STD status and encourage testing as appropriate.

Patient Privacy and Electronic Health Records

Privacy issues don’t only crop up in matters related to STD and STI testing. Today, the majority of medical facilities are eschewing paper medical records in favor of digital data collection in electronic health records (EHRs). Many EHR systems store data in the cloud.

EHRs are supposed to improve treatment and cut costs. But more research is needed to verify the accuracy of these claims.

What we do know about EHRs is that large corporations are leading the way towards a complete digital takeover of medical records.

Related content: EHRs Can Advance Good Medicine If Doctors Are Aware of the Risks

Both Apple and Google already have a hand in the digital health record world. Apple’s iOS 11.3 includes a personal health record feature, and Google Cloud has partnered with several medical facilities to put patient data all in one place.

Ethical issues related to digitization of patient data

The digitization of patient data comes with ethical questions. Both patients and healthcare providers alike question the security of EHRs.

1996’s Health Insurance Portability and Accountability Act (HIPAA) included a provision ensuring the confidentiality and security of protected health information.  However, HIPAA has not been updated for the modern era. Today, the security of EHRs is a job for healthcare facilities themselves.

Related Content: Evolution of the Hippocratic Oath and Medical Ethics

The Healthcare Industry’s Financial Incentives

Healthcare is big business in America. However, many healthcare providers believe that financial incentives are negatively impacting patient quality of care. Many believe that the very foundation of the medical industry is at risk due to the monetization of healthcare.

In the current medical landscape, the cost of treatment and/or medication is prohibitive for many.

According to the Centers for Medicare and Medicaid Services, in 2017, U.S. healthcare spending reached $3.5 trillion. That number translates to more than $10,000 per person. Myriad individuals find that their healthcare costs exceed their budget.

The cost of a cancer drug used to treat chronic myeloid leukemia is unattainably high for many patients according to a 2015 study. The authors of the study concluded that the high cost of life-saving drugs may even be immoral:

“Charging high prices for medicine needed to keep someone alive is profiteering. It is akin to jacking up the prices of essential goods after a natural disaster.”

Ethical Considerations in the Field of Nursing

The American Medical Association (AMA) introduced the inaugural Code of Medical Ethics in 1847. In it, the AMA laid out the following ethical principles, to be practiced by all healthcare professionals, from surgeons to nurses:

  • Autonomy
  • Beneficence
  • Nonmaleficence
  • Justice

Patient autonomy

Patient autonomy is the idea that those seeking treatment can choose to accept or decline a healthcare professional’s recommendations. And today, considering the often prohibitive cost of care, patients may decline treatment more than any other time in history.

These facts mean that the idea of justice, or a patient’s right to an equal and/or fair distribution of resources, may no longer have a place in modern medicine. Thus, the role of nursing professionals is more complex than ever.

Good communication between nurses and patients is imperative so that healthcare providers can fully grasp a client’s situation. For example, if a patient refuses treatment, his or her nurse should work to understand the reasons behind the decision.

If the patient is concerned about the cost of treatment, a nurse or healthcare provider may be able to offer a solution that better fits into a patient’s budget. Conversely, if a patient is refusing treatment due to fear, a nurse can help ease their patient’s mind.

Related Article:  The Ethical Strain on U.S. Medical Care

Final Thoughts

Today’s health care ethics challenges are myriad, from patient confidentiality to data and record privacy. Healthcare providers, including social workers and nurses, should familiarize themselves with modern medical ethics issues in order to ease patients’ anxiety.

The Code of Medical Ethics remains as relevant as ever, despite the digitization of healthcare records and the often-prohibitive cost of care.

Treating the whole patient today is a complex endeavor, and digital health records may help streamline the treatment process.

Healthcare professionals have a duty to give patients all relevant information regarding their treatment. They must also always “do no harm,” as the Code of Medical Ethics advocates.

Clinical trials are a big part of medical research and have lead to some amazing breakthroughs in the way we treat everything from diabetes to cancer. One common type of trial is known as a “double-blind” clinical trial. During this type of trial, half of the participants receive a placebo instead of the medication being tested. No one, even the doctors administering the drug, knows who is receiving the placebo and who is receiving the actual medication.

While it can be an effective method for removing the variable of researcher bias, it does raise an interesting ethical question. Are there ethical concerns with providing a placebo for a cancer patient, for example, who might be participating in a study as a last-ditch effort to survive?

 

Why use placebos in clinical trials?

Placebos have been used in clinical trials for nearly as long as there have been clinical trials. The introduction of a placebo, or sugar pill, as they’re colloquially known, is used to measure any placebo effect variable within the results of the trial.

The placebo effect is observed when a patient has a positive result from taking a placebo. In essence, the patient’s belief in the treatment creates a result. This result might be due to the patient’s perception, but there is nonetheless a measurable change in the patient’s health’s or well-being.

As a side result, the use of a placebo can also be used to eliminate or reduce research bias. Researchers might be more willing to select trial participants with a terminal diagnosis, for example, if a double-blind scenario isn’t being used. These terminal patients might be looking to find a miracle in a new experimental drug. These selections could encourage bias in the results of the trial.

Related Content: Five Reasons Why You Should Participate in Clinical Trials

Ethical concerns for placebo use

There are multiple schools of thought when it comes to the ethics of placebo use in clinical trials. Placebos make sense for drugs and treatments in their first clinical phase. During Phase I, the optimum dosage is determined and any major side effects present themselves. This stage of the trial is almost always conducted with healthy adult volunteers, and the placebo provided to half of these volunteers provides a source of valid scientific information.

In later phases of the trial, the question of ethics becomes an issue. Many researchers feel it is unethical to withhold a treatment that has had its efficacy proven during earlier trial phases just to collect additional scientific evidence. Withholding such treatment is the antithesis of the physician’s oath to do no harm.

This argument puts commercial pharmaceutical companies at a disadvantage, mainly because they are under significant pressure to prove their new treatment is somehow better than any existing treatments. Existing treatments, on the other hand, have only had to prove themselves more effective than a placebo.

Some professionals feel it is unethical to conduct trials without the use of placebos, arguing drug trials are not a black-and-white industry. There are many shades of gray that have to be considered—up to and including the fact that a double-blind trial isn’t always able to establish drug efficacy.

 

Greater risks than ethics

Additionally, though this has little impact on ethics, studies completed without a placebo group might not have all the information they need to safely prescribe and market a drug. A trial conducted to study the risk of myocardial infarction associated with the use of a drug known as rofecoxib utilized two groups:

  • One group taking just the drug
  • One taking the drug along with a non-steroidal anti-inflammatory drug like naproxen

With no placebo group, it was impossible to tell if the use of rofecoxib increased the risk of myocardial infarction or if naproxen decreased it. As a result, the drug was eventually pulled from the market because of a high risk of sudden cardiac death after another 3-year study was conducted.

 

What about ‘Right to Try’ laws?

Right to Try laws have been passed in 33 states, as of the time of this writing. These laws allow terminally ill patients to bypass the FDA’s “Compassionate Use” application process and receive treatment utilizing experimental drugs that have passed Phase I of their clinical trials. Compassionate use applications can take months or years to be approved, and many terminally ill patients just don’t have that kind of time to wait.

Unfortunately, these Right to Try laws could have a negative effect on clinical trials. Patients may be more likely to utilize the Right to Try option rather than signing up for a clinical trial. Under the law, patients will be guaranteed treatment with the experimental drug, while patients who sign up for a trial might only have a 50% chance to actually be treated with the drug.

The Right to Try laws are often the last chance a terminally ill patient has, and should be continued for compassion’s sake if no other reason. That said, their effects on participation in clinical trials should be taken into account.

 

Finding the balance between ethics and science

There are a growing number of medical professionals who consider the use of placebos unethical, especially when the efficacy of the treatment has already been proven. The most likely course of action will be to find a balance between the ethics and the science of the situation, and anyone who’s ever worked on an ethically gray topic knows how difficult that can be.

It’s hard to say whether we should compromise the use of placebos because of these ethical considerations when the same placebos may end up providing information that could protect or save lives once the drug completes its clinical trials.