There are specific types of sampling for clinical trials or any research, and they are random, systematic, stratified, clustered, and convenience sampling, and the sampling type may result in older patients being excluded. There are other types of sampling, but these are the more usual. Convenience sampling is one where it is probably easiest to get the sample size required.

Of course, each clinical trial will also, in addition to their sampling method, have rule-in and rule-out criteria eligibility. Here, the principal investigator makes decisions based on factors they wish to control, such as a history of alcoholism, familial sudden death syndrome, or other medical conditions. Age can be an important concern and serve as a “rule-out.”

Of course, institutional review boards bear responsibility here, too. Questioning by board members regarding the reason for not including older patients is mandatory.

Every patient has the potential to bolster our knowledge and research base if we see past our bias. And what would a specific bias be in these cases? Are we selecting in only those who have many decades of life left and tossing aside those with possibly one decade of life left to them? How much is a decade of life worth these days?

The Ethos of Medical Ethics

Clinical research trials are essential for any headways to be made in the many wars medical science is currently engaged in worldwide for various diseases. It would stand to reason that these research trials would be comprised of individuals of all ages, ethnicities, and gender groups to ensure that we are utilizing a representative sample to come to valid results. But that doesn’t seem to be the case with two groups, particularly older adults and Black individuals.

Regarding Black individuals, we know a long history has contributed to a reluctance to engage in clinical trials. No one needs to tell us about the horrific trials in the South with Black men who thought they were being treated for a sexually transmitted disease (syphilis) when, in fact, they were being followed to catalog the progression of the disease and their deaths. They never received the medicine that would have cured them, penicillin.

Despite mandates by the federal government to ensure the inclusion of women and minorities in all federally funded research, African Americans continue to participate less frequently than Whites. Lower participation rates among African Americans have been reported across various study types (e.g., controlled clinical treatment trials, intervention trials, as well as studies on various disease conditions, including AIDS, Alzheimer’s disease, prostate cancer, and other malignancies, stroke, and cardiovascular disease).

Medical history must always keep that in the record books and understand the impact it has had on generations of Blacks. There are other examples of equally unethical research or experiments on this group.

Now, we face another difficulty or impediment, and that is in the area of age disparities in some clinical trials, but cancer is of utmost importance.

Cancer and the Aged Patient

Statistical census data released annually by major research entities indicate that 10% of those over the age of 65 have some form of cancer. The latest census figures for the United States suggest that there are over 65 million people in this age group, both male and female. Logically, this indicates almost seven million in that group have cancer.

Worldwide the World Health Organization indicates that each year 10 million people die from cancer worldwide, or one in six. In the US, in the 60–70-year-old group, cancer is the second most common cause of death.

The FDA has noted an underrepresentation of older adults in cancer-treatment trials. The National Cancer Institute’s data show decreasing enrollment in trials both FDA and SEER with advancing age. At ages 75 and greater, only 9% of research samples were in this age group. At 65, it was 36%.

By 2030, it is estimated that 70% of people over 65 will have some form of cancer. If that isn’t a compelling reason to begin enrolling this population into cancer clinical trials, I have to question the trials.

Arrogance and Ignorance in Research

I have to question the rationale for the trials, who is underwriting the trials, the background of the principal investigator in terms of ageism potential, and how significant the trials would be in a rapidly aging world. We cannot deny that the silver tsunami is upon us and will require billions of dollars of care for these patients.

If we do nothing or little to provide innovative, new treatments garnered from new research, we will find ourselves trying to swim without any floaties to support us.

One research paper indicated that if we fail to include this population in cancer clinical trials, there will be a lack of generalizability that can lead to challenges in treatment decisions for OA (older adults) and concerns regarding health inequity. Do older adults receive equal medical treatment today? I question that.

The editors indicated that trial structure, design, physician perspective, and patient or caregiver perspectives must be carefully evaluated and included as required. They call for actionable recommendations to address the challenges these types of cancer trials face, which may have been ignored in the past.

There is no room for ageism in clinical research, and when found, it must be addressed as strongly as possible because lives are on the line. To do less is extreme arrogance and ignorance in the face of what is coming down the road. No gods are working in medicine, and everyone must adhere to the strictest ethical guidelines possible and care for those who may have, either on purpose or thoughtlessly, fallen through the safety net.

Yes, I have heard chiefs of service refer to older patients as PIAs (no, it’s not Prolonged Infantile Apnea), a term which should have been erased from medicine many decades ago but is still held close in the minds of those who live in the past.

The post No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias appeared first on Medika Life.

A 50-year-old, moderately obese patient walks into a medium-sized medical practice in New York and asks to see a doctor. He’s been having nagging chest pains and is concerned, naturally so, about a heart attack. He never reaches the inner sanctum of a consulting room or gets to see a doctor. He is refused access to the clinic, despite a heated argument with the receptionist, as he is unvaccinated against Covid-19.

The receptionists have clear orders from the practice managers. Without conclusive proof of vaccination against Covid, patients are to be denied access to a doctor.

The patient makes his way back to the parking lot but never makes it home. Sitting in his hot car in the lot, trying to catch his breath, that chest pain returns and he suffers a fatal heart attack.

Scenario 2

A patient, let’s call her Gail, suffering from Covid symptoms and respiratory distress is taken to a hospital in a small town in Texas. There is a wave of Covid sweeping the town and only one bed remains open in ICU. Gail and another Covid patient wait on gurneys in the entrance hall, desperate to be admitted. Nurses evaluate the two individually and discover Gail has not been vaccinated, despite being over 60, obese, and suffering from a heart condition.

The other patient, also in respiratory distress, has been vaccinated. Hospital guidelines are clear and the nurses respond accordingly. Survival rates are far higher for vaccinated Covid patients. Gail is told she will need to return home and the bed is allocated to the vaccinated patient. The odds of him recovering are stacked in his favor, the outlook for Gail is poor. She dies at her home, 48 hours later.

The complexities of care

I’ve provided you with these two fictitious, yet practical examples of how care may be denied to Covid patients based solely on their Covid vaccination status. The reasons for the examples are twofold. Firstly to highlight the possible consequences of decisions made to withhold care and secondly, to highlight the complexities and nuances of the topic.

What if, in scenario 1, the patient had experienced his heart attack in the waiting room rather than in his vehicle? Would the medical staff simply have stood by idly and watched the patient die or would they have administered care, in contravention of their own policy? I tend to think the latter and most doctors would support this view.

There is a vast difference between emergent care and someone simply shopping for a doctor.

When, for example, ICU beds in hospitals are in short supply, unofficial triage protocols dictate that care be prioritized for those who display the greatest potential for survival. Sadly for the unvaccinated, their survival rates for severe Covid are terrible when compared to the vaccinated.

Most of us assume doctors are oath-bound and ethically obliged to provide care to any and all patients, but the truth is, as always, a little more complex than that.

In August of this year, the debate went public when an Alabama family doctor posted a sign on his office door that stated, as of October 1, he “will no longer see patients that are not vaccinated against COVID-19.” The doctor then sent letters to his current patients saying, “I cannot and will not force anyone to take the vaccine, but I also cannot continue to watch my patients suffer and die from an eminently preventable disease…

The topic of refusing care has become so contentious in pandemic afflicted America that in September the American Medical Association (AMA) intervened, issuing a strongly worded statement on the matter.

In general…a physician should not refuse a patient simply because the individual is not vaccinated or declines to be vaccinated. The commitment to care for those who are sick or injured carries with it a duty to treat in other circumstances as well, including public health crises when a physician may face “greater than usual risks to [their] own safety, health or life…” Nor may a physician ethically turn a patient away based solely on the individual’s infectious disease status, or for any reason that would constitute discrimination against a class or category of patients.

Oaths, Duties, and Guidelines

The AMA statement was however qualified by the inclusion of the following extenuating conditions that the Association suggested may be considered when assigning care.

• It may be ethical for a physician to refuse to treat an unvaccinated patient if accepting him or her “would pose a significant risk to other patients in the practice”.
• If meeting the individual’s medical needs would ‘seriously compromise’ the physician’s ability to provide the care needed by their other patients.”

The American Medical Association Code of Ethics further muddies the water, creating contradictions when it comes to guidelines regulating the provision of care. Section VI of its code reads,

“A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.”

So that part encourages the physician’s right to choose. Then, in section IX of the code, it says the following,

“A physician shall support access to medical care for all people.” [emphasis added]

So which one is it, and how do individual doctors decide which sections are applicable, given the ambiguity? Another recent opinion by the AMA states that,

“Physicians may not decline to accept a patient for reasons that would constitute discrimination against a class or category of patients.”

Again, it’s not a hugely specific statement and fails to provide a definition for either class or category. Is the AMA Code referring specifically to race, gender, sexual orientation, and similar demographic features? Could one argue that the unvaccinated constitute a class or category?

The Hippocratic oath, taken by all doctors, doesn’t help much to clarify things either, as it doesn’t specifically address the issue or provide a direct answer to the question. What Hippocrates does offer is a more generalized statement that many interpret to mean care for anyone.

“Into as many houses as I may enter, I will go for the benefit of the ill…”

Physician Steven H. Miles, the author of the classic The Hippocratic Oath and the Ethics of Medicine, notes that “…people from all walks of life sought out and paid Greek physicians for health care. Cobblers, vine tenders, shepherds…soldiers, potters, prostitutes…[and] slaves…”. It would therefore appear that Hippocrates was in favor of providing unconditional care to any and all.

The ‘doctors are just human beings’ aspect

It’s a part we often overlook and yet, it plays a huge role in this debate. Your provider is a person just like you, subject to all the emotions you experience. Emotions like anger, frustration, and recently, for many doctors, pandemic-induced exhaustion, are dealt with on a daily basis.

Most medical practitioners perceive the vaccines as their only effective tool to curb and control the spread of Covid-19 and they, unlike you, have to deal directly with the deaths of those who refuse it. They watch unvaccinated people die from severe Covid, over and over again. It’s like Groundhog Day for viruses.

They see their other patients refused beds in ICU and dying from non-Covid related emergencies simply because the unvaccinated are occupying the ICU beds. Many doctors see you, the unvaccinated, as having blood on your hands.

In short, these doctors are fed up, frustrated, and at the end of their tethers.

If, the doctors argue, you aren’t willing to do this one simple thing to protect yourself, why should they bother to help you and potentially expose their other at-risk patients to potential death? It’s an argument that ignores certain key issues surrounding vaccines, but it is a more than natural human reaction to our current situation and a key factor in the provision of care that cannot be ignored.

So where does that leave the unvaccinated?

Legally, your doctor can not be forced to provide you with care. There is no service offered anywhere, in any industry, that is not provided subject to certain terms, and medicine and health are no exception. Morality and ethics aside, any medical professional can choose to decline care and cite any number of reasons for it.

Add morals and ethics to the mix however and the situation changes. Doctors and caregivers who place their patient’s needs at the heart of their practice will be far less inclined to withhold treatment for their patients, irrespective of the patient’s vaccination status. As with HIV in its early days, some doctors will allow fears for their personal safety and human bias to affect their decision to provide care.

If you are unvaccinated, you will find certain providers, clinics, and practices less than receptive to accepting you as a patient. Luckily for you, a little shopping around will soon enable you to find a doctor who is more than happy to provide you with care. If the doctors place their faith in the vaccines, as most do, what risk then do you pose to them?

If however, you turn up unvaccinated at an overcrowded hospital in search of a bed and a vacant respirator in ICU, you’re probably going to be right out of luck.

The post If You’re Unvaccinated for Covid Can Your Doctor Refuse to Treat You? appeared first on Medika Life.

As June’s Pride Month comes to a close, Ohio Governor Mike Dewine signed an anti-LGBTQ bill into law allowing medical professionals to refuse to treat any patient over moral or religious beliefs. The religious objection provision did not come up in Congress for a stand-alone vote. Instead, the legislation was buried inside of the 2,438-page budget bill which passed last week.

Based on the wording of the law, Ohio health providers and insurance companies have “the freedom to decline to perform, participate in, or pay for any health care service which violates the practitioner’s, institution’s, or payer’s conscience as informed by the moral, ethical, or religious beliefs.”

Women’s health advocates and the LGBTQ community are sounding the alarm. The sweepingly broad language opens the doors to discriminatory practices by health providers and insurance companies who fail to remember that the patient always comes first. 

The wording of the law goes way beyond issues of sexuality and gender. The law permits any healthcare provider to deny any medical services based on religious or moral objections.

The law is not limited to abortion services, contraceptive coverage, transgender care, or HIV medications. The legislation allows the individual provider to make a determinative choice of who they want to treat. 

The Federal EMTALA Act prohibits the US Health system from turning its backs on any patient in need of emergency care stating, “EMTALA requires Medicare-participating hospitals with emergency departments to screen and treat the emergency medical conditions of patients in a non-discriminatory manner to anyone, regardless of their ability to pay, insurance status, national origin, race, creed or color.

Ohio Governor Dewine’s bill provides a workaround for providers who wish to deny care to a patient based on moral or religious objections. The Ohio law states providers are “responsible for providing all appropriate health care services, other than the particular health care service that conflicts with the medical practitioner’s beliefs or convictions until another medical practitioner or facility is available.”

In Ohio, doctors and nurses, who refuse to treat a patient, must provide emergency care until they can transfer the patient to another provider or hospital willing to treat them.

Data from the Kaiser Family Foundation show that most Americans, regardless of their political party, do not support discriminatory healthcare policies. Republicans, Democrats, and Independents agree the US Health system should not refuse to treat patients based on their life choices. 

Governor DeWine and the Ohio legislature failed to recognize one of the most important healthcare provider aspects. 

Patient care is about the patient. Not the provider.

The Ohio law fails to acknowledge one of the most challenging aspects of medical care. Doctors, nurses, and other healthcare providers work hard to avoid value judgments when providing care. We work to see all patients as worthy. We try to avoid bias. 

Healthcare workers treat patients. We do not judge who they are or what choices they made to need our service. Doctors and nurses do not treat the patients we like and turn away those who are not aligned with our morals and values. 

Good doctors and nurses do not pick and choose. We separate ourselves from value judgments to treat the patient in front of us. No matter who they are.

Medical care is about placing value on each person’s life. Although challenging, health providers try to avoid considering patient culpability when treating people. Our personal feelings must be checked at the door. 

We treat the person in front of us. 

Pulmonologists do not refuse to treat or blame a chain smoker for getting lung cancer. Trauma surgeons treat drunk driving victims and the perpetrators equally. We do not refuse care to gang members who get shot or deny Covid-19 treatments to those who refuse to wear masks. 

In Obstetrics and Gynecology, we provide care to pregnant women who use illegal drugs and prescribe PrEP therapy to those with multiple unprotected sexual partners. We don’t insert personal bias or value judgments into patient care. We try very hard to do exactly the opposite.

A health provider’s job is to counsel patients and empower them with knowledge. We discuss the health risks of their life choices. 

We do not deny care to those who live their lives in ways differently than we do, even if we find a patient’s life choices morally offensive. 

The post Ohio Sneaks LGBTQ Discrimination Law Into Budget Bill appeared first on Medika Life.

These intellectual property laws include copyright, trademark, patents, and trade secrets. However, although written with the best of intentions, a struggle is now being waged for and against these patent laws concerning vaccines. How the parties will decide will determine who lives and who dies. It’s no longer a matter of sitting patiently as the final give-and-take is completed. Time is of the essence.

The question, of course, is whether or not there should be some suspension of the law for the benefit of millions who will die if not given a vaccine. In the midst of all of this, we see vaccine highjacking, internet hacking for formulas, and scams offering “vaccines” over the internet.

The result of patent protection, as we await the opinions and the legalese, is death with little question.

Reading the various articles, we cannot forget the classic psychology experiment regarding the man who needed medication for his wife that he couldn’t afford. Laurence Kolberg provided in the classic Heinz dilemma:

A woman was on her deathbed. There was one drug that the doctors thought might save her. It was a form of radium that a druggist in the same town had recently discovered. The drug was expensive to make, but the druggist was charging ten times what the drug cost him to produce. He paid $200 for the radium and charged $2,000 for a small dose of the drug. The sick woman’s husband, Heinz, went to everyone he knew to borrow the money, but he could only get together about $1,000 which is half of what it cost. He told the druggist that his wife was dying and asked him to sell it cheaper or let him pay later. But the druggist said: “No, I discovered the drug and I’m going to make money from it.” So Heinz got desperate and broke into the man’s laboratory to steal the drug for his wife. Should Heinz have broken into the laboratory to steal the drug for his wife? Why or why not?

People in the millions around the world are dying for lack of the vaccine for Covid-19. The United States is said to have millions of doses of the Astra-Zeneca vaccine stockpiled but unreleased.

Thirty million vaccine doses sit in a plant in Ohio awaiting the finish-and-fill process. Tens of millions of doses are in a factory in Baltimore. Fear of unavailability may be holding these precious 40 million doses within the United States.

But now, patent protection is rearing its head. The true intent of the law wasn’t to prevent its distribution but to ensure “a property right that can be licensed, sold, mortgaged or assigned.”

The Vaccine Patent-Protection Arguments

The question remains whether or not it is essential to suspend any intellectual property rights that relate to Covid-19 vaccines. The nexus of this question may be a life-or-death decision for those countries or individuals who cannot afford the vaccine.

The poor, those in distant areas, or who are of an unseen underclass, may be the victims of this lack of altruism in the service of protection of property rights.

A precedent for providing free vaccines was set in 1955 by Dr. Jonas Salk, the polio vaccine developer. Once the vaccine was available, Salk indicated he would seek no patent for it.

When asked why Salk wouldn’t seek patent protection for his discovery and who owned the rights to it, he is said to have replied, “Well, the people I would say. There is no patent. Could you patent the sun?”

A similar instance for providing his vaccine was shown regarding Israel. Salk made available all of his information and his laboratory for an Israeli scientist, Natan Goldblum. Goldblum then took the information and set up a laboratory to manufacture the vaccine in Israel. In 1957, Israel provided vaccines for youngsters there.

In the early 2000s, a treatment for AIDS was distributed free in developing countries, although pharmaceutical companies wished to make it available at market price. Public pressure, as well as government efforts, resulted in its free distribution.

Covid-19 Vaccines’ Quandary

The forces pro and con regarding vaccine availability are now being heard around the world. Some call for the People’s Vaccine approach, similar to what Salk intended, but others hold for pharmaceutical firms’ intellectual rights and patent protection.

Oxfam believes, “To end this pandemic, we need a People’s Vaccine: a patent-free, mass produced, and fairly distributed vaccine available free of charge to everyone, rich and poor alike.” Their belief is that intellectual property concerns prevent the free distribution of vaccines which could, inevitably, lift the pandemic scourge.

The contrary view is whether or not vaccines and their patents should be allowed to depart from any pre-existing laws or rules related to intellectual property rights. Countries such as India and South Africa ask the World Health Organization to waive these rights to help protect their people.

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement is the center of the struggle related to patented technologies related to the production of the Covid-19 vaccine. It is to this body that the suffering countries are appealing for a waiver relative to Covid-19.

It is seen as a struggle between the rich and the poor. Although there have been pledges to offer the vaccine at cost by some companies, prices have varied wildly, going from $2 to $40 per dose.

In light of the current crisis, some ask for a review and potential revision of patents as they relate to vaccines. Pharmaceutical firms do not share this view and see it as a potential conundrum for their continued financial health. Patents have been involved in legal struggles before as in the case of Henrietta Lacks and the development of HeLa, a licensed method for medical research.

What is at issue appears to be the qualification of compulsory licensing to manufacture vaccines.

The components of the TRIPS agreement do have a provision for what is called compulsory licensing for production within a country for its own use.

The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences, and to determine what constitutes a national emergency.

Initial efforts to obtain a license for production during an emergency having failed, a company can then apply for compulsory licensing.

The bottom line is that unless we have more millions vaccinated worldwide, the virus will continue to replicate in new variants less susceptible to current vaccines. Worldwide travel will serve as a vehicle of virus transmission.Death tolls will mount, economies will weaken, and the world will suffer as a whole; no country will be spared.

The post Vaccine Patents Come with Ethical Dilemmas Bringing Life or Death appeared first on Medika Life.

We treat the patient in front of us. No matter who they are.

The Arkansas legislature decided to toss this principle tenet of healthcare out the window. 

Doctors and nurses in Arkansas can now refuse to treat patients based on moral or religious objections. Arkansas Governor Asa Hutchinson signed, The Medical Ethics and Diversity Act, SB 289, into law on March 26th.

The law states its purpose is “to protect all medical practitioners, healthcare institutions, and healthcare payers from discrimination, punishment, or retaliation as a result of any instance of conscientious medical objection.”

Health providers’ moral objections are the focus of the new Arkansas law, but the law does not protect patients from discriminatory practices from a healthcare provider. Instead, Governor Asa Hutchinson relies on federal law “that prohibits discrimination on the basis of race, sex, gender, and national origin.”

The Arkansas Medical Ethics and Diversity Act, SB 289, does not include language protecting against discrimination based on sexual orientation or gender identity. 

Most media reports have framed the law as blatantly anti-LGBTQ legislation. The Human Rights Campaign fought against the bill because it allows doctors to refuse care for transgender and LGBTQ patients. Arkansas health providers can now legally refuse services to anyone based on a moral objection as long as it is not an emergency or violate federal EMTALA guidelines.

But the wording of the law goes way beyond issues of sexuality and gender. The law permits any healthcare provider to deny any medical services based on religious or moral objections.

ACLU of Arkansas Executive Director Holly Dickson pointed out the risks stating, “making it easier to deny people health care isn’t just wrong, it’s dangerous.” 

The Arkansas law fails to acknowledge one of the most challenging aspects of medical care. Doctors, nurses, and other healthcare providers work hard to avoid value judgments when providing care. We work to see all patients as worthy and try to avoid bias. 

Medical care is about placing value on each person’s life. Although challenging, health providers try to avoid considering patient culpability when treating people. Our personal feelings must be checked at the door. We treat the person in front of us. 

Pulmonologists do not refuse to treat or blame a chain smoker for getting lung cancer. Trauma surgeons treat drunk driving victims and the perpetrators equally. We do not refuse care to gang members who get shot or deny Covid-19 treatments to those who refuse to wear a mask. 

In Obstetrics and Gynecology, we provide care to pregnant women who use illegal drugs and prescribe PrEP therapy to those with multiple unprotected sexual partners. We don’t insert personal bias or value judgments into patient care. We try very hard to do exactly the opposite.

Our job is to counsel patients on the risks of their life choices. We do not deny care to those who live their lives in ways differently than we do even if we find certain choices morally offensive. 

Patient care is about the patient. Not the provider.

Multiple medical organizations are speaking out. So far, the Arkansas law is opposed by the American Academy of Pediatrics, the American Psychiatric Association, the American Psychological Association, the American Medical Association, the National Association of Social Workers, the University of Arkansas for Medical Sciences, and the American College of Emergency Physicians. Other organizations are likely to oppose the law as well. 

This statement by the Arkansas Chapter of the National Association of Social Workers summarizes the general consensus saying, “no patient should ever be obstructed from receiving legal healthcare based solely on a provider’s personal values.”

Arkansas legislators and Governor Hutchinson must know this law will be challenged in court. Let’s hope the court remembers when it comes to patient care, the patient always comes first. 

The post The Anti-LGBTQ Arkansas Health Law is Dangerous for All of Us appeared first on Medika Life.

We can build software to do, quite literally, anything. The sky and the extent of our creative processes are literally the only limits. Facial recognition software is a great example. It has made spectacular advances in the last five years and not even a mask can help you evade its ever-present gaze. Unlimited budgets presented by eager backers from the NSA and almost every other intelligence and law enforcement agency on the planet have fostered and ensured a focused industry dedicated to the pursuit of perfecting the human version of “Where’s Wally”.

It may interest you to know that a deep learning company Megvii, in association with Huawei, has developed A.I. that can, with a reasonable degree of accuracy, determine the ethnicity of an Asian face. This machine learning model described in a recent paper successfully predicted Chinese Uyghur, Tibetan, and Korean ethnicity. Impressive you might say, and particularly helpful in a dystopian world where the Chinese allegedly seek to identify certain segments of their population.

Quite a few A.I. projects have focused recently on identifying race, gender, age, and facial features simply from the sound of your voice. The systems then generate a face they construct based on what the software has identified in your voice. These tools have created an ethical minefield made all the more complex by the inclusion of the gender debate and clearly defined sexes, parameters not addressed by the developers.

There is nowhere on the planet that you can escape the reach of A.I. It has infiltrated our lives, lives in our pocket via our smartphones, runs our cars, our homes, and is now making choices for us. It’s been doing that for a while. Think of the route Siri worked out for you this morning to avoid traffic. It’s a simple, but effective example of the impact of A.I. 

Did you decide how you reached your place of work or did A.I. deliver you, safe and gridlock free, to the office? Who just stocked your refrigerator, you or Alexa? Any music tracks you haven’t heard in a while from your music library? You do realize there’s nothing random about the random playlist option? A.I. doesn’t do random.

Ethics in Science

Medicine‘s raison d’etre’ is the care of human life. For this reason, and this reason alone, a carefully considered set of ethics developed alongside the profession, keeping everyone safe and ensuring medicine placed a premium on the value of human life. For generations, this ethical system of checks and balances has protected both the patient and the provider. That time is at an end and it is not only A.I. that reflects this change in the field of medicine.

Encroachment and overlapping technologies from other fields of science and commerce have become commonplace in modern medicine. Technologies with the potential and ability to revolutionize and reshape the healthcare profession are introduced to a shell-shocked medical industry on an almost daily basis. 

The scale of deployment of new technology is dizzying and unparalleled and we are simply not prepared for it. Not ethically, not morally, and not as a society.

Medicine can not rely on other fields of science or third-party agents to respect its code of ethics. Nonrelated fields, like the study and development of artificial intelligence, have until recently, only touched on the moral and ethical implications of their work in passing. New committees and bodies are gradually emerging from within these industries to address societal ethics and safety, but they remain in their infancy as they grapple with the larger debates centering on societal values.

Unlike medicine, scientific projects and papers generated by the computational sciences arent held up to rigid ethical scrutiny and it is easy to understand why. Until very recently, A.I. ethics only occupied the domain of philosophical discourse. Technology’s rapid rise caught everyone by surprise, including the technologists.

Take the example of the challenge of building a face simply from a voice sample. Any decent self-respecting coder is going to jump at the opportunity to develop it. The thrill of the challenge aside, the potential applications for systems like this are legion, and that’s exactly where the rub comes in.

Technology or A.I. is neither self-aware nor prescient. It can, currently, only perform tasks we ascribe it and A.I. does not provide flawless solutions. A.I. makes mistakes, simply because it is, for now, and the foreseeable future, reliant on human coding, on our biases, and the flawed models we provide it with. 

We are fallible and therefore A.I. is fallible. It is the one key hurdle A.I. may never overcome. To create itself, it requires systems. Systems we develop, reflecting our biases and flawed ethics. 

Recognizing the Limits of Technology

Humans are unethical and immoral creatures. We are all guilty of crossing lines we recognize and choose to ignore, from small daily transgressions to world-altering genocide. Our world is habituated by areas of gray, shades of right and wrong that we blend on a continual basis, most often for the benefit of self. Technology, in particular, A.I. is a tool, an extension of our interpretation of this world, and as always, the tool is not inherently evil. Its fate or intent rests in the hand that wields it.

This is why the field of ethics matters in medicine. It is also why the medical industry cannot rely on outside models to dictate the safety and implementation of its patient-centered view of the world. This is both irresponsible and naive and a failure to address immerging technology now will result in a dystopian future for medicine, possibly within the decade.

Tools do not, and cannot make decisions on our behalf or the behalf of the patient. They exist merely to serve both provider and patient alike.

Urgent rules of engagement are required that emanate from within medicine, rules that dictate the reach and limit of Artificial Intelligence in human-based care settings.

Let’s examine that statement in relation to care settings through the use of a simple example. We’ll return to our facial recognition software and the potential for this software to interpret intent and emotion. Assume it’s deployed into casualty wards across the country to improve patient assessment. The software analyses patient’s faces, picking up signs it interprets as distress, and places patients awaiting care into a queue, based on its assessment of their distress.

I can almost guarantee you that a system similar to this is currently under development. Software used by the DOD to analyze faces for perceived threats would be an excellent starting point and it would make sense to incorporate this into a diagnostic system to prioritize triage. 

The problem arises when we empower A.I. with the ability to make its own decisions, rather than using its output to make our own decisions. When A.I. decides who gets to see the surgeon next, we have a problem. That is unacceptable.

The true purpose of A.I. is to supplement the human brain, to allow for millions of variables we cannot process, to consider everything, and to increase or expand the options for human-based choice. The ways in which we choose to implement these digital gifts in the practice of healthcare are where the issues arise.

Redefining Medical Ethics for a Technological Future

A.I. exists to augment, not dictate. This one simple rule should form the basis for a new arm of medical ethics, one that engages specifically with technology. At the heart of this supplemental code of ethics, as ever, are the patients, their safety, their health, and their access to care.

It isn’t simply the care patients receive, but their access to it, and the spider of technology has spun an all-encompassing digital web that envelops all of modern healthcare. A.I. is everywhere. It controls data and mines patient information on behalf of third parties, health insurers, drug developers, and federal agencies. 

Each A.I. system functions independently and is subject to the biases and preferences hardcoded by developers, instructed accordingly in their pursuits and design.

Patients are punished in a myriad of ways. Refusal to care, higher insurance premiums, medications prescribed based on algorithms rather than clinical evidence, flawed diagnoses, the list is endless. A.I.-based diagnoses of scans, for instance, pick up early signs of disease not visible to the trained human eye, leading to preemptive treatment for conditions that may or may not, eventuate over time. 

Evaluative software is another example, as it analyses provider efficiency. Do you think for an instant that healthcare chains, hospitals, and large clinics deploy this software for the benefit of the patient? Results and rankings are based on profit and efficiency, not patient-oriented outcomes. This is the inevitable cost of developing health care solutions in commercial isolation.

The issue is broad, complex, and impacts all aspects of healthcare. Telehealth is another perfect example. What do we know of the companies that offer remote platforms for mental health care providers? Has it occurred to the proponents of these systems that unbeknown to you or your patient, the A.I. running the system is under instruction?

It is more than likely analyzing voice patterns and facial signals to decide what the most appropriate services would be to offer to both you and your patient the next time either of you opens a browser? 

You aren’t alone in that virtual consultation. There is a third party present and it’s called A.I. To assume otherwise is to be naive.

Who checks? Who validates the software we have so willingly accepted into the lives of providers and patients as being beyond reproach? It’s time to wake up from our self-indulgent siesta, before commercial interests completely replace the inefficient and naive humans that inhabit healthcare. A.I. won’t be to blame, it is simply a tool in the hands of unethical forces who would have their way with the highly profitable platform of healthcare.

It is up to the industry to look out for itself and now would be a really good time to start. The clock has been running for a while. A.I. was never, and never will be the enemy. It is an essential and integral part of healthcare’s future. We simply need to manage it responsibly, for the sake of our patients.

The post The Ethics of A.I. in Healthcare Must Be Urgently Addressed appeared first on Medika Life.

The study obtained consent for exposure to a pathogen with a 12-week delay in curative treatment. Details that are withheld are relevant to human subject concerns in current COVID-19 vaccination research.

The article published in Annals of Internal Medicine sparked a brief, but intense expression of outrage on social media from infectious disease experts, clinical trialists, and ethicists.

Little sign of this controversy is preserved in the biomedical literature. What was said by experts on social media about the ethics of studying infectious diseases in this unusual study should be available in a systematic search of the literature. Especially with the urgency of determining the efficacy and safety of vaccines for COVID-19 with healthy research participants.

Sensitive to the controversy this article had elicited, the official Twitter account of the journal tweeted

Apparently, there were few on Twitter who took advantage of this offer who succeeded in getting a letter published.

What was said by experts on social media about the ethics of studying infectious diseases in this unusual study should be available in a systematic search of the literature. Especially with the urgency of determining the efficacy and safety of vaccines for COVID-19 with healthy research participants.

Our published letter to the editor has largely gone unnoticed because of an exceptionally stubborn journal paywall, combined with delays and glitches in the indexing of letters to the editor. I could not find this letter in recent searches of the journal website or through Google Scholar.

My best friend and colleague University of Pennsylvania Professor of Medical Ethics & Health Jon Merz, MBA, JD, Ph.D., had made polite, persistent, but ultimately futile attempts to get the details of what was told to the two students and what assurances were given in securing their informed consent.

Jon wrote emails to the first author, senior author, and Research Evaluation Board of the Leiden University Medical Centre, Leiden, The Netherlands.

After some exchange of niceties, the response seemed to be an emphatic “Echt, niet!”

The article’s senior author noticed that Jon was an ethicist and presumed that Jon might want to publish on this issue. She reserved the right to protect her team to be the first to publish what was done to ensure informed consent. The team was collaborating with ethicists at Leiden University and she suggested that they would be publishing details.

The senior author also noted that her research staff had not given serious consideration to self-experimentation involving deliberately infecting themselves.

She ended further correspondence with:

Given the ethical debate around controlled human infection studies, we believe that it is important to take the utmost care in informed consent procedures, guidance of our volunteers and the public opinion.

Subsequent publications from this group have not revealed what was told to these students, not even in advisement about how to manage risks to normal volunteers in COVID-19 vaccine research.

Actually, a strong case can be made for cohort-specific informed consent, which involves disclosing specific risks to prospective subjects with particular personal characteristics.

The Head of the REB replied that she preferred that Jon obtain information and consent forms from the senior author of the study. She did not respond to further inquiries.

Our letter

The journal did not require us to sign over the copyright of the letter, so here it is in its entirety:

We read with interest the short report by Roestenberg and colleagues about the experimental infection of 2 graduate students with male cercariae of Schistosoma mansoni.1 The overarching hypothesis of this study is quite provocative. Results would be potentially clinically relevant, except data from only 2 of the originally proposed 17 subjects proposed in the trial registration were reported.2 Information in the trial registration indicates that recruitment is no longer occurring.

No reason is given for writing up the paper with such a small subsample of what was proposed. One is left wondering whether recruitment failed because of the risks and burdens of a study requiring exposure to a pathogen and a 12-week delay in curative treatment. No information is provided about recruitment strategies, target subject population, or information disclosed in the consent form. Was an incentive offered and was it consistent with the risks and burdens of the study? We requested the consent form from the senior author and the IRB, but our request was refused.

Despite recruiting only two subjects, there were six authors and a larger coHSI clinical trials team of 20. We wonder why no members of the team experimented on themselves. The Nuremberg Code provides some guidance for dangerous experiments that hold out no prospect of therapeutic benefit: “5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury could occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.”3 While death or long-term injury from this experiment was unlikely, the principle behind this provision of the Code has a persuasive rationale.

If an experiment is too dangerous or imposes too high a risk and burden, only those who are most informed and free of undue pressures and coercion should be experimental subjects — namely, the investigators. No researcher (or IRB member) should ask others to do anything that they themselves would not do. If recruitment failure was due to the inability to find enough unaligned people willing to undertake such an experiment, we find it ironic and telling that none of the investigators would step into the breach for the good of their science.

We hope the investigators will be open and transparent about their recruitment and consent methods, as others may face similar barriers in trying to replicate and extend their important work.

The authors’ reply

We thank the authors for their interest in our research and sharing their ethical deliberations. Recruitment for this trial has been completed as proposed (n=17) and final trial visits for the last group of volunteers are currently taking place as planned. We aim to provide a full report of the trial results as soon as possible and anticipate final data collection in April 2019. Volunteers were financially compensated for their time and travel expenses according to accepted Dutch standards for medical research with healthy volunteers.

We have performed a thorough review of our informed consent procedures, volunteer expectations, risk assessments and motivation. The results of this study will also be made publicly available. Given the importance of the clinical findings of the first participants in this study to the medical community, we have been specifically requested to publish the clinical details of these initial cases as soon as possible and not await the end of the trial. We apologize for any concerns we might have caused with regards to failed recruitment or early termination and will keep you updated on trial publications.

Note that this reply seems to promise that the results of the larger study will be published. It did not say whether these publications would include the details of the protection of human subjects, including this study’s procedure for ensuring informed consent.

It is very odd to publish results obtained from the first two research participants when a larger study is in progress. This article could be seen as premature and inappropriate because any effects may prove false positives with the accumulation of more data. The authors want to attract attention to their preliminary results, but risk the likelihood of promising results getting more attention than the not-so-promising, but more valid results they will have later.

Responsible researchers do not publish preliminary results from an ongoing study without a very good reason. That is Best Research Practices 101.

Particularly since this group is taking the extraordinary step of publishing results obtained from the first two of a planned larger study, the medical and scientific community have the right to know how consent was obtained and if there were any participants who declined participation once they were fully informed.

If the results of this study are so important that they must be shared at this preliminary stage — after collecting data from only two subjects — then so are the procedures by which the results were produced, including informed consent.

There are unaddressed ethical concerns about this study. What were prospective participants told about possible adverse events, including the risk of death? How much were participants compensated in recognition of this risk? Are there special issues in these participants being students at the research team’s university and their perhaps feeling pressured to give consent?

Our suggestion that the investigators consider doing this research experimentally expose themselves — not someone else — to the pathogen has strong precedent.

A systematic review identified 465 documented instances of medical self-experimentation, including by researchers who went on to receive the Nobel Prize.

Walter Reed’s Yellow Fever Commission in Cuba in 1900 allowed mosquitoes suspected of carrying the deadly disease to bite Commission members, but Reed excused himself from having to do so. One member of the commission developed yellow fever and suffered lifelong chronic ill health. Another member died from the disease.

A classic paper in the New England Journal of Medicinethat is regularly assigned reading in medical ethics classes discussesAuto-Experimentation — An Unappreciated Tradition in Medical Science.

The paper notes

Obermeier, in his efforts to find a cure for cholera that then was epidemic in Berlin, allegedly injected blood from a patient with cholera into himself, and died.

Swiss chemist Albert Hofmann accidentally poisoned himself with LSD and then began purposely auto-experimenting with lower dosages to discover its psychedelic effects.

The NEJM article poses an important ethical question for the Leiden research team:

Investigators cannot serve as subjects in all scientific experiments. But the widespread practice of auto-experimentation raises a fundamental question about the philosophy of research: Is it ethical to subject another person to an experiment if the researcher did not do the experiment on himself first?

What are Katayama syndrome and schistosomiasis?

According to Lancet Infectious Disease, Katayama syndrome

Is an early clinical manifestation of schistosomiasis that occurs several weeks post-infection with Schistosoma spp (trematode) worms…Katayama syndrome appears between 14–84 days after non-immune individuals are exposed to first schistosome infection or heavy reinfection. Disease onset appears to be related to migrating schistosomula and egg deposition with individuals typically presenting with nocturnal fever, cough, myalgia, headache, and abdominal tenderness.

According to the World Health Organization (WHO), schistosomiasis:

Is an acute and chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma. Estimates show that at least 229 million people required preventive treatment in 2018. Preventive treatment, which should be repeated over a number of years, will reduce and prevent morbidity….

Transmission occurs when people suffering from schistosomiasis contaminate freshwater sources with their excreta containing parasite eggs, which hatch in water…

Chronic schistosomiasis may affect people’s ability to work and in some cases can result in death. The number of deaths due to schistosomiasis is difficult to estimate because of hidden pathologies such as liver and kidney failure, bladder cancer and ectopic pregnancies due to female genital schistosomiasis.

Are psychology graduate and medical students members of vulnerable populations?

Regulations vary by country, but in the U.S., federal rules require that institutions overseeing research conducted with human subjects take special precautions to ensure that consent is obtained is fully informed, voluntary, and without coercion. The concern is heightened when individuals are in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.

U.S. regulations especially cite children, economically deprived persons, and prisoners as vulnerable populations. Students and employees of an institution are not explicitly mentioned.

Yet, researchers can expect that in the review of applications to experiment with students, consideration will be given to how consent is obtained without coercion and how students and employees can decline participation or withdraw from research without fear of reprisals.

Special issues with Leiden University psychology graduate students

The Dutch academic environment is highly competitive. Career advancement is dependent on the demonstration of research productivity, as quantified by the number of authorships on peer-reviewed publications.

Dutch Ph.D. theses consist of a collection of peer-reviewed publications with interspersed commentary. Co-authorships on research conducted by graduate students figure heavily in the hiring, promotion, and tenure of junior and senior faculty.

The publications listed on the curriculum vitae of many department and laboratory heads in the Netherlands consist mostly and sometimes almost entirely of authors stemming from Ph.D. student research.

Dutch psychology students face particular challenges in being able to recruit patients for Ph.D. research from medical hospitals and clinics staffed and controlled by other disciplines. Most of us who have done research in those setting find that authorships can be expected for anyone willing to authorize access to medical patients. These academic administrators are responsible for securing publications for their own colleagues, staff, and Ph.D. students and can be expected to look after them.

I have had to acquire a new data set at another Dutch medical center for a completed manuscript reporting results based on secondary psychometric analyses of self-report measures.

The head of the clinic had given permission for use to some data from a study completed long ago in the clinic, before her time. But she did not respond to repeated emails offering authorship for a minimal of effort sufficient to comply with journal guidelines for determining authorships.

We asked at the last minute before the manuscript was uploaded for her to provide permission to name her in an acknowledgment. The clinic head insisted that she be able to recruit her two new postdocs to read and make comments on the paper. The three of them should then become authors or else the manuscript could not be submitted. We got a new data set elsewhere to reanalyze. As customary, we again offered an opportunity to the source to become an author, but we received a note thanking us but declining.

Decision-making about authorships in Dutch medical settings often involves some compromise between international ethical standards for awarding authorships and the need to maintain collegial relationships with those in control.

In recent years, Leiden University has had a number of scandals about research integrity, gift authorships, and denial of credit for student and early career persons’ contribution to research in the Schools of Education and Psychology.

This past year, the Netherlands Board on Research Integrity (LOWI) concluded that a former professor of psychology at Leiden University was guilty of breaching several rules of scientific integrity. This conclusion was based on the findings of the Academic Integrity Committee (CWI) of Leiden University:

The CWI identified four violations of scientific integrity: (1) blood sample testing without the legally required permission of the Medical Ethics Review Committee, (2) irregularities with publications, (3) repeatedly selectively omitting research results without reporting or explaining this, and (4) submitting grant applications with incorrect (incomplete and manipulated) research data.

Transparency in research ethics during the pandemic

Achieving control over the world COVID-19 pandemic depends on unprecedented international cooperation and the sharing of data obtained from diverse settings and the ethics and informed consent with which these data were obtained.

These were always Best Research Practices and now, more than ever is the time to enforce them.

Academic institutions are expected to share data as well as basic details of their methodology to allow their research to be replicated. Especially in the midst of a pandemic, researchers should be forthcoming and disclose fully the details of how they informed health volunteers about the risks of unprotected exposures to pathogens in their research and how truly voluntary consent was obtained.

We did not anticipate that pandemic would soon be upon us when our letter was published in Annals of Internal Medicine. But we saw no reason why these authors from LUMC should not answer a reasonable question about how they protected human subjects.

Dear Professor Meta Roestenberg of Leiden University Medical Centre,

Could you please inform the scientific community about how you persuaded two students to put their health at risk in your study by getting exposed to pathogens?

Kind regards

Jim

References

1. 1.Langenberg MCC, Hoogerwerf MA, Janse JJ, van Lieshout L, Corstjens PLAM, et al. Katayama Syndrome without Schistosoma mansoni eggs. Ann Intern Med 2019; Jan. 8. doi:10.7326/L18–0438.
2. 2. Roestenberg M. Single-sex controlled human Schistosomiasis infection: safety and dose-finding. https://clinicaltrials.gov/ct2/show/NCT02755324 (accessed January 20, 2019).
3. 3. Nuremberg Code. United States v. Karl Brandt et al, 6 Fed Rules Decisions 305 (1949).

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Have you just unwittingly provided one of the billions of DNA samples currently being collected across the globe? If you’ve been tested for Covid then the answer is a definitive yes. The Covid-19 test allows laboratories the opportunity to extract your DNA from the sample you’ve provided. The purpose of this article is not to prove that this is being done, but rather to question why no one has sounded the alarm bells. They should be ringing themselves off the wall and yet, the silence is deafening.

The premise is simple. The opportunity has presented itself. Two of the largest groups intimately involved with fighting the pandemic are government and large pharmaceutical conglomerates. If we have learned anything in the last few months it is that neither are to be trusted and both lack the ethical backbone to resist the temptation.

Why would they want your DNA? The list is as endless and the motivations as diverse as the samples themselves. DNA data is arguably one of the primary currencies of our brave new world. Corporations and governments that control this data can control you and I and quite literally, the world.

The purpose of this article is not spread wholesale panic but to raise awareness. The media and the scientific community have been completely remiss in highlighting this issue.

The value of your DNA

The US government holds a database of unsolved crimes with DNA samples as their only evidence. Somewhere out there, in cities across America, wanted felons are wandering into clinics to get tested for Covid. Do you think this once in a lifetime opportunity is going to pass by unnoticed? Can you imagine the potential savings months down the line to law enforcement? Future criminals have just left their name, address, and DNA at a testing center near you. Homeland Security must be rubbing their hands in glee.

Recently, in 2019, a US state judge forced a public genealogy site, GEDmatch, to allow police to search its entire database of DNA profiles. A detective wanted to find distant relatives of a serial rapist in hopes that their family trees could help him home in on a suspect — even though most of the 1.3 million people who shared their DNA data with the site had not agreed to such a search.

From a monetary viewpoint, access to a collection of DNA on a global or country wide scale would fundamentally shift power bases. It’s not a statement made lightly. Data – and your DNA is essentially data waiting to be interpreted – is our new currency and we now possess the computational power to make sense of it. We can now abuse it as never before.

Mortgages, college applications, work, access to healthcare and more will be determined by the content of your chromosomes. It is already happening across the US and other countries.

Companies can, for instance, refuse you insurance or load your premiums based on genetic markers in your DNA. It’s a simple but very clear example of how your DNA can be used against you. This already happens, as referenced further below in this article.

Your life will almost undoubtedly be dictated by your DNA in the not too distant future as more and more genetic markers are identified. Mortgages, college applications, work, and access to healthcare will be determined by the content of your chromosomes. Get tagged with a gene that indicates alcoholism and good luck getting that mortgage. Your risk profile just went north.

Test positive at birth for a genetic marker that indicates an increased risk of psychotic behavior and your future in politics is almost certainly guaranteed. A joke of sorts but you understand the real-world implications. They are terrifying and they aren’t the subject of science fiction. They are now a scientific fact and the subject of very concerned discussion in the halls of legal academia.

These concerns have led to the creation of LawSeq. A website has been set up with a searchable database of US laws that govern your genetic data. Just to be clear, currently, in the US, your genetic anonymity is almost never guaranteed.

Until recently, the issues we’d faced interpreting or identifying shared traits or markers from DNA samples was an insufficient data set and the means with which to analyze said data. Covid has just solved the first issue and quantum computing and vastly improved computational power are rapidly overcoming the second.

The pandemic has given governments across the globe the opportunity to harvest our DNA on a scale hitherto unimaginable. Never before have so many people handed over their DNA so willingly, apparently blissfully unaware of the potential for abuse. Not a single question has been raised about it. Not by the press and not by the public. Why? The paranoia and panic surrounding the pandemic may be partly to blame. It’s the perfect cover at a pivotal moment in the world.

The Covid-19 test is the ultimate DNA harvesting tool. It comes with a name, an address and is given without the need for coercion. In fact, people have been lining up for it, with hundreds of thousands being tested daily across the US.

Whilst the purpose behind getting the test isn’t primarily about your DNA, but trying rather to identify traces of the Coronavirus in your system, this opportunity will not be lost on those who make their living from our DNA or those who stand to profit from it. The temptation to peek into how DNA is impacting positive and negative tests will be overwhelming.

Legally, where do you stand?

Great question and not an easy one to answer. It depends, to a large degree, on where you live. If it happens to be Iceland, you couldn’t care less. Almost every single individual in Iceland has turned over their DNA voluntarily as part of their Genome project.

It is an admirable undertaking with sound medical goals and a desire to better understand how our genes affect our health and susceptibility to diseases. It also been done with the utmost transparency and the willing engagement of the Icelandic people.

Move across the frozen seas in the direction of America and things change. They change dramatically. There is no transparency, no oversight and a plethora of financially and politically motivated individuals just waiting to screw you over, and in case you didn’t realize, your DNA is ripe for the picking.

You do, in theory, own the right to your DNA in the US. It’s the reason a court order is required to make you hand it over should you be unwilling and the court determines it is in the public interest. There are however a number of huge loopholes in the law. The problem with the current system comes down to the fact that genetic data can have multiple uses beyond its original one.

Say you participate in a research study or clinical trial that generates DNA data. A federal law protecting human subjects, called the US Common Rule, mandates that you be informed of how your data might be shared prior to signing a consent document. In 2016, Congress passed the 21st Century Cures Act, which also provides any federal research subjects with a certificate of confidentiality.

This restricts the researchers collecting your genetic data from releasing it to law enforcement or other government agencies. And if that information were to somehow be illegally obtained, through a hack or some other breach, it would be inadmissible in court.

Great, but say you want to add that genetic information to your electronic health record, so it’s available to your doctor. Now it becomes a piece of personal health data, governed by the Health Insurance Portability and Accountability Act (HIPAA).

Under HIPAA, your genetic data can’t be given to your school or employer, but law enforcement agencies are entitled to access it without a warrant if you’re the victim or suspect of a criminal investigation.

Your insurance provider can also access it. That’s why, in 2008, Congress passed the Genetic Nondiscrimination Act, or GINA, which prevents health insurers from denying coverage or jacking up prices based on someone’s genetic predisposition to various health conditions. (They can still do that if your genes make you actively sick – GINA becomes basically useless once you show symptoms.)

GINA also doesn’t apply to long-term-care insurance, life insurance, or disability insurance, though it does ban employers from using it to decide who gets hired, fired, promoted, or given a raise.

Business and government want your genetic data. They will ensure they get hold of it, one way or another

It is however going to get worse. Much worse, as this recent article from Wired points out.

OF ALL THE provisions of the Affordable Care Act – “Obamacare,” if you’re on a first-name basis – the one that seemed the most uncontroversially humane was the guarantee that insurance companies could not use so-called preexisting conditions to deny coverage. If you had a chronic illness or had recovered from something and lost your insurance, or if you quit or got fired, you could still get onto a plan.

But the odds say that sick people stay sick or get sicker, and insurance companies don’t make a profit by paying out. By voting to repeal the ACA and replace it with … well, with something, not totally clear what, the Republican-led House of Representatives seems to have nuked the preexisting condition guarantee. The new bill, which passed in a close 217–213 vote, allows insurance companies to charge sick people more. According to one nonpartisan analysis, it allocates enough money to cover those higher rates for just 5 percent of people with preexisting conditions.

Think it can’t get worse? The ACA specifically protected against discrimination for preexisting conditions that showed up through genetic tests. You might not be sick yet – in technical terms, the illness has not manifested – but if you, for example, test positive for one of the pathogenic variants (a less X-Manly term than “mutation”) in the BRCA gene that predisposes you to breast cancer, you could still get covered. If the House bill becomes law, that protection vanishes.

The tip of the iceberg

Business and government want your genetic data. They will ensure they get hold of it, one way or another, either in collusion with each other or independently. Their reasons for wanting the data are not to better serve you. Never ever make that mistake.

The information contained in your DNA will be used for social engineering. It is already happening right under our noses. Your DNA will used to “stream” you for careers, health and life insurance premiums, access to services and, depending on the lengths we take it to, possibly even prison, if they ever identify markers associated with criminal behavior.

New biological genetically-based weapons are no doubt already under discussion in the Oval Office. Imagine being able to target a gene unique to a certain population or demographic. It’s a can of worms we can’t close in the hands of individuals we cannot trust and the pandemic has offered them the keys to Aladdin’s cave. We need to ensure they aren’t using them.

So what do we do?

The opportunity to exploit Covid-19 testing clearly exists, but is it happening? There is no hard evidence to confirm it, but sufficient reason to assume it is being done covertly. Under a Trump-led regime that is actively legislating to enable free commercial access to your DNA, why would they intentionally choose to overlook this free goldmine of data?

Can we stop it? Probably not, is the short answer and that of course raises the question of where that leaves you an I? Do we simply accept the inevitability of a society regulated by genes rather than free choice? Or do we raise our hands in united outrage and demand changes? Wholesale changes, to our rights, our freedoms, and our privacy.

A simple legal undertaking by all testing facilities not to perform any tests beyond the scope of the original purpose of a test would be a start. An undertaking to destroy all sample materials provided in a responsible and timely manner and not to share, or allow access to, any of the materials or identifying information provided by the patient. Massive penalties and the prospect of prison would enforce these undertakings.

Were you asked to sign anything when you underwent your Covid-19 test? How long was the document and what information did it require? What was in the fine print and did you read it?

Anyone with access to these testing documents is welcome to email copies or photos of the documents to us. This open invitation extends to the testing laboratories should they wish to actively address the concerns raised above and perhaps highlight how they deal with these issues currently. Submissions can be made anonymously to privacy@medika.life and all submissions will be considered confidential.

You can also reach out to your local government at the state level. Social media in this instance becomes our best friend. Publically highlighting an issue often ensures it is addressed in a transparent and accountable manner and also serves to draw the attention of a noticeably absent media.

The post Is Your Covid Test Being Used to Covertly Harvest Your DNA? appeared first on Medika Life.

A therapist or, more appropriately, a psychotherapist, in this case, is a word we never associate with evil. The word evil is reserved for use in the religious realm as is the concept of the Devil (see Elaine Pagels’ “The Origin of Satin” or Bart Ehrman’s “God’s Problem”).

With the popularization of therapy, possibly related to its extolling by the wealthy and famous and availability of health insurance, change has come. Psychiatrists even considered whether or not if “evil” exists in anyone. Were there evil people (like Jeffrey Dahmer, John Wayne Gacy, and Dennis Rader) or were they exhibiting a form of mental illness or a personality disorder?

The question is no mean feat of theory consideration but one that has medical and legal implications. Does evil exist, or are we reverting to a less enlightened age where religion explained all for us in our wish to have answers?

Psychotherapy is dependent on introspection but if evil exists in some persons, is this concept relevant? An evil drive pushing toward acts concomitant with it wouldn’t seem open to change by careful inspection of one’s psyche.

If someone, with a predilection toward skirting the rules of ethics related to psychotherapy, were to be in a position of power, what would they do? Could they harm us in some way? If so, what would the harm be?

We need only to read some of the newspaper reports of questionable or unethical behavior of famous therapists such as Freud. What did Freud do? For one thing, he pressured patients to contribute to his own therapy association. Then, too, Freud considered his patients “riff raff” and convinced a man that he was a homosexual, urged him to divorce his wife and marry another of his patients.

Urging his patients to rid themselves of their neuroses, Freud failed to heal himself from the serious anxiety that stopped him from facing patients (he sat in a chair at the head of his famous couch), and his enuresis.

What about the equally famous Albert Ellis, the father of Rational Emotive Behavioral Therapy, who “Like Kinsey, Ellis is not the monogamous type. He has admitted to having sex with patients, though only after treatment had ended.”

Depending on state licensing laws, therapists may have a relationship with a former patient under certain circumstances. Some states this is never condoned, others say it’s fine two years after therapy ended. All licensing authorities, too, have a code of ethics by which licensees must abide.

Anyone engaged in the mental health field as psychiatrists, psychologists, social workers or counselors of any stripe need to do it be truthful to themselves and their patients. But there are those who are in the field for reasons which, if revealed, would lead to professional sanctions.

Famous or infamous?

The question of evil in a psychiatric setting would seem to have been settled by an editorial in one of the psychiatry journals.

As the editorial indicated, “Psychiatrists are medically trained in the scientific method, not in the diagnosis and treatment of evil.… (This) is the province of the philosopher and theologian and… Introducing the concept of evil into forensic psychiatry hopelessly complicates an already difficult task.”

The editorial writer indicated that evil is an exclusively human quality, and one not observed in animals. He was attempting to address one psychiatrist’s formulation of a “Depravity Scale,” which was to standardize measures of evil to provide some guidance for other psychiatrists.

In the context of this article, I am not attempting to categorize evil as anything other than a therapist’s wishes to optimize power, prestige, individual desires, or money. I do not believe they are genuinely evil, but some are not what I would see as sterling characters. Most try their utmost to deserve the trust their clients’ place in them.

However, some of the most famous names in mental health have been accused or have committed the most egregious actions. For some, it was a casual concern with their academic preparation (Erik Erickson); for others, it is ethical violations, sexual deviancy, murder case involvement, or drug use. Some engaged in unethical research. All of them are human with feet of clay.

The media is rife with the more sensational stories of therapists who have engaged in non-professional behavior. For example, they have slept with their patients, borrowed money, were involved in business relationships, controlled their patients’ lives as in the case of one famous music star, and generally allowed themselves to freewheel their lives as they wished. Of course, none of this is acceptable and violates ethical guidelines for all of the mental health professions.

Psychotherapists are supposed to help us deal with the difficulties in our lives, but that’s not always the case. Too many therapists are unqualified to practice as they do, are not licensed, got degrees from unaccredited schools, lack the training required, or are in it for the money.

Freud detailed his own love of money in his letters where he referred to it as “laughing gas.” Others may have more nefarious reasons for hanging out their shingle.

According to Dr. Jeffrey Masson, Freud denied the sexual abuse of children. ‘’The silence demanded of the child by the person who violated her (or him) is perpetuated and enforced by the very person to whom she has come for help,’’

The shingle designating a professional may also be deceptive as it indicates the person is “Doctor…” Does that mean MD, Ph.D., or what? And what type of Ph.D. did they receive? Honesty in this profession, as in others, is not a strong suit for all. How do you tell who to avoid? No one provides guidelines.

The knaves with degrees

Some therapists are so taken with their alleged ability to perform “semi-miracles” in their patients’ lives that they have stated things which are more than unacceptable. For example, one therapist who, in violation of ethics, encouraged group members to socialize and date. I know of this having heard it from others.

This licensed individual also told one of the patients that if she discontinued therapy with her, the patient would commit suicide within one year. The patient went on to work with another therapist.

In a few years, she earned her master’s degree and then went on to study for a doctorate in psychology. Thoughts of suicide never entered her mind. The therapist remained in practice and, seemingly, no charges were filed. The patient wanted to walk away and forget about it entirely.

A psychologist, who had a young man referred to her, began to engage in what she called therapeutic sex with the young man. The sessions went on for almost a year. After each sexual encounter in her office, he gave her a check for $150 and scheduled their next session. One of my professors told our class, “I have never heard of a therapeutic erection” when he heard about this.

The unethical behavior continued until he worked up the courage to discuss it with his parents. They reported the woman to her licensing board, and the board suspended her license.

One of the problems with suspension is that these individuals often return to practice in the future. During the period of supervision, they do nothing untoward, but afterward, we have to wonder. The system, in general, relies on the patient pool and the public to report.

Active violators of ethics or who engage in illegal activities are not sought out by investigators because there are so few who are hired to perform this work. Many states have only two people to look at all the licensed persons within that state.

This ongoing surveillance does not include those in the medical profession since they perform their own investigations, but, here too, it is left to someone to report. Often these persons are not reported for a variety of reasons which may include intimidation, blackmail, or threats of being cut off from treatment or being sued.

Steps to protect yourself

A short guide to assist in therapist selection is needed. Here is a list of suggested questions to ask and places to find help should you need it.

1. Do not depend on ads for therapists. Big ads mean that a person is willing to pay for these displays. They will expect to recoup the funds in therapy fees. Ads=no assurance of anything.

2. No one can guarantee you anything. It is against ethical guidelines for psychologists to provide any assurance of results or a guarantee.

3. Ask all the questions where you need answers. Don’t permit anyone to intimidate you. You are paying for a service, and you are a customer no matter whether they call you a patient or a client.

4. Some questions: What degree do they have and in what discipline? A school administration doctorate is not a doctorate in psychology. A doctorate or a Ph.D. needs explanation. Do not skip over this one. Where did they go to school, and where did they do their internship? Plaques on the wall are meaningless. Too many wall decorations can be bought.

5. What license do they have? Being “certified” is not equivalent to being licensed.

6. What is their theoretical orientation? Have them explain it to you. Take notes. Google anything you don’t understand if they tell you something unusual.

7. What is the treatment plan, and what is the timeframe for your therapy?

8. In what do they specialize? Examples: medical illness, anxiety, stress reduction, family therapy, cognitive-behavioral techniques, etc. Is a specialist someone who treats anyone who comes through the door? No, they’re not. We are not dealing with a Chinese restaurant menu here.

9. To which professional organizations do they belong? Google that one, too.

10. What is their cancellation policy? Insurance cannot be billed for missed sessions.

11. Check online with their licensing board to see if there are any actions pending currently or past violations. Also, check for lawsuits online.

If you need more assistance in deciding whether to report a therapeutic transgression or not, where do you go? The usual course would be to your state’s licensing board.

An internet search for “(state) licensing board for (psychologists, psychiatrists, social worker, counselors)” should return the result you seek. At this time, there is no national licensing board for the professions.

AI is getting in on the act

As in so many things, technology is being brought into the realm of therapy, but is it free of the problems we’ve seen in artificial intelligence (AI)? Large data sets are not devoid of major issues of bias, miscalculation, and assumptions.

The construction of an AI algorithm that would help to select a good candidate as your therapist remains problematic. Some data sets are heavily loaded in terms of bias. Hidden bias includes ageism, sexism, and racism.

For persons with specific wishes, such as someone of a similar ethnic background or religion or any other particular, the program may select only those individuals. At the same time, it will exclude individuals who might be better suited in terms of forming a therapeutic relationship.

The therapeutic relationship

The therapeutic relationship is the basis of all successful therapies. It is here that you must be most attuned to how you feel when you are in the company of that person. Of course, this assumes that you will have a screening or initial consult after you have made a selection for a therapist.

Would selecting a therapist based on shared demographic features result in a good match? The belief may be that this individual has shared life experiences which would make them more apt to understand the individual’s life experiences.

Often, a person who seeks a therapist with a similar racial or ethnic background as a preferred provider may delay therapy while waiting for a “match.” But an analysis that looked at individuals matched in terms of background and those who weren’t matched indicated the treatment outcomes were similar. Therefore, the therapist doesn’t have to share a collective life experience, ethnicity, or other background feature. But AI might skew the results in that direction.

The selection of a therapist is of utmost importance because they are dealing with your life and assisting you to make needed changes. As you would with any significant decision, check carefully, be satisfied, and never hesitate to question. It is your life.

The post Beware the Strike of an “Evil” Therapist appeared first on Medika Life.

How can a physician trained in dermatology, pediatrics, obstetrics, podiatry, or orthopedic surgery suddenly be pulled into life-saving, gut-wrenching work as an emergency medicine physician? What prepared them for this, and how can they perform adequately when no one has a few minutes to prepare them for the next emergency patient who needs ventilation? How do they handle the dreadful death toll of this virus? What about their medical ethical mandates when triage is indicated?

The practice of medicine for many of these out-of-specialty physicians will be and is dramatically different during the present and future pandemics. Once working in private offices, group practices, or standing in state-of-the-art operating rooms, these physicians will find themselves propelled from 20th-century medicine into new standards of 21st-century medicine within months. New-normal medicine will be uncharted territory and will tax many of their beliefs about healthcare.

Work may, at times, be in field hospitals set up by the military or in settings that formally were used for other purposes, including hotels, convention centers, factories, warehouses, tents, and even ships. Their former, somewhat predictable, daily routine will no longer be the routine that continues. How will it affect them?

Suicide Statistics Provide a Small Window

The consequences are far-reaching not only for the physicians but for their families and their fortunes. Physicians are not immune to emotion, and we know that by the statistics that lay out, in an eye-opening fashion, the suicide data relative to physicians.

“Suicide is the second most common cause of death for 10-to 34-year-olds in the United States. The average age of matriculating medical students in 2017–2018 was 24. Thus, it should come as no surprise that medical students, residents, and attendings — like other Americans — are affected by suicide and mental illness.” An estimated 300 physicians commit suicide each year, but that statistic is old and doesn’t factor in a pandemic with all of its increased stress and potential burnout in addition to PTSD (post-traumatic stress disorder).

Out of Specialty Work

Graduating medical students take the Hippocratic Oath, which sets their career course in terms of ethics and morals. The newly-minted physicians expect to undergo grueling years of advanced training. Each specialty has been carefully evaluated for their interest and their skill-level.

Personalities, too, were included in the search for their future career goals. Once the COVID-19 hit, the best-laid plans of new docs went awry in directions no one could predict.

Not all physicians are “people” people but now their choices would be limited by a pandemic. Some would have preferred the solitude of a lab or the absolute authority of the operating room rather than the M.A.S.H environments into which they were thrown.

Challenging is one of the words most often used by physicians and nurses who were placed into unfamiliar circumstances where they needed to refresh or learn new medical protocols. The main concern, now for all, was how to protect themselves and their families, once they were off shift. They knew they were dealing with an incredibly deadly, contagious virus, and it clung to clothing, cardboard, metal, and several other materials and hours if not days.

The virus was also resistant to heat, presenting an additional difficulty in labs and treatment rooms. It wasn’t easily killed or removed.

Even the protective materials that were to be used required special procedures for removal. An additional concern was whether or not there would be adequate masks and gowns on the next shift. If the work didn’t demand yeoman-like skills, the anxiety of not having PPEs (Personal Effective Equipment) available heightened the stress.

Whoever thought needed supplies or machines wouldn’t be there when needed for treatment or to save a life? It was out of the realm in which they had trained.

Ethical Concerns Arise

The difficulty which presented itself was whether or not to refuse reassignment to an ED (emergency department) or chance catching the virus while working in the ED. Did physicians come to their work as a “calling” or a profession that made difficult ethical choices a part of the bargain?

Some in healthcare would refuse to work if PPEs weren’t in adequate supply. Was ethics involved at all here? Is it mandatory that physicians and other healthcare workers put themselves in situations of extreme risk and death to satisfy their oath to serve? What does a physician do in situations of scarcity where staff or equipment is at a premium?

One article has addressed this situation in a forward-thinking manner. “Educators should begin to teach “scarcity thinking” in medical schools, residencies, and other training situations, with a focus on practical guidance for contingency planning and a deep understanding of the ethical principles of implementing crisis standards of care.” We can put this under “lessons learned” during a pandemic.

Is working in an area in which the MD is not a specialist an ethical issue? A medical license does not indicate a need to be a specialist and often states the person is qualified to practice medicine and surgery. But a license is poor protection.

The duty to treat has come up against new ethical issues outside areas of specialization. And the situation is not contained in one area of the country or the world or to one specialty. “We’re hearing a lot of anxieties from specialists who don’t know what the right thing to do is for their patients,” said Dr. Megan Ranney, an emergency physician in Rhode Island. “Dermatologists, ophthalmologists, we’re even hearing from dentists.”

As a result of the difficulty of the pandemic, “U.S. medical professionals on the front line of the coronavirus pandemic are lobbying policymakers for protection from potential malpractice lawsuits as hospital triage care and physicians take on roles outside their specialties.”

For any physician or healthcare professional, COVID-19 difficulties can be daunting. In the case of physicians wishing to volunteer or to come out of retirement, the American Medical Association has provided a series of guides.

For employed physicians, the AMA has another bit of assistance in “a guide that concisely covers key strategic, legal, and contractual considerations. The information is not to be construed as legal or financial advice, but it is meant to help physicians understand their rights and the opportunities available to them.”

In the greater scheme of things, a physician, NP (nurse practitioner), PA (physician’s assistant), or another licensed medical professional has to weigh the moral/ethical issues as well as the legal ones. Guides may provide some valuable information, but the law isn’t always so clear-cut on many matters, and medicine is one of them.

The swirl of a pandemic created in 2020 will change all of us and the world in which we live, the hospitals in which we work and the labs where advances are made to name a few. Many other changes may come as surprises or welcomed advances but that’s not for us to know today. We await a better tomorrow after this dark night in which we now find ourselves.

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