In Consenting to Treatment, What Does a Patient Need From a Doctor? Trust? What Else?

By Gordon Bugbee

Patient dignity and self-determination demand consent before treatment. The more consequential or irreversible the treatment, the more informed and explicit the consent should be. But consent, practically and psychologically, rests on trust. (Not necessarily the trustworthiness of the clinician, but how much the patient trusts the physician.)

In the case of major surgery or other consequential, invasive procedure, the surgical consent, affirmed in the moments prior to anesthesia, is at the end of a chain of consents and releases, each of which is predicated on a patient’s trust in the clinician making the request.

The trust a patient places in the surgeon, oncologist or other physician is itself the culmination of a series of trust relationships starting with the patient’s primary care physician (or ER doctor in an emergency). Successive trust relationships, with specialists or a surgeon, are built on and are partly a transfer of trust from one clinician to the next. Institutional affiliation, endorsements by collateral providers, and reputation may also play a role.

The Community Ethics Committee has been wrestling with issues related to informed consent in the context of concurrent surgery (in which the principal surgeon is engaged in operating on two different patients within the same time frame). The CEC's report is expected to be published here this fall. 

This brought us to a wider discussion of consent in general and most recently to a consideration of the underlying relationships. (We were led to this in part by “An entrustment model of consent for surgical treatment of life-threatening illness: Perspective of patients requiring esophagectomy,’ by Martin F. McKneally and Douglas K.Martin; Journal of Thoracic and Cardiovascular Surgery, August 2000.)

Here is a list of some of the dimensions or facets that seem to characterize that relationship as seen from a patient’s perspective, in no particular order.

I (patient) trust you (provider). That means I assume:

• That you are well trained and competent to undertake the treatment proposed
• That you will try your best to take good care of me
• That you are honest with me (‘whole truth and nothing but the truth’) about the benefits and risks of the proposed treatment (or at least with yourself if I am unwilling or unable to hear those things)
• That you are aware of and respect your own limits
• That you will have adequate rest and nutrition before beginning any complicated or taxing procedure
• That you will not allow distractions to compromise my care (or will refer me to another competent and trustworthy provider who can focus on my care)
• That you have confidence in your own abilities and training
• That you will ask for help or refer me to other more appropriate providers when it is in my best interests
• That in any conflict between what’s best for you (or the institution) and what’s best for me, you will place my interests first
• That your treatment recommendations are driven by clinical considerations not your financial or professional interests
• That you will not entrust any part of a procedure or my care to anyone you are not convinced is competent and trustworthy
• That you will align your tolerance for risk with mine. That is to say, if I am willing to undergo a risky, unorthodox or experimental treatment, you will not refuse to provide that treatment (within the bounds of responsible medical practice) to protect your reputation or peace of mind. Conversely, if I am unwilling to undertake a particular course because of the uncertainty of the outcome, you will not apply undue pressure or seek to overturn my decision to satisfy research goals or your personal preferences.
• That you remember, no matter how routine a procedure is for you, it is a big deal for me
• That alleviating my suffering is at least as important to you as treating any illness I may have.
• That you know that I am more than the sum of my medical circumstances.
• That you know that the capacities and experiences that you value most may not be the same for me.
• That my values and preferences may be different from yours and that you will learn and respect any differences.
• That you will not presume to make consequential decisions for me without consulting me (or those who know me best)

This list is no doubt incomplete, and perhaps we all have a slightly different list of presumptions. The more constitutionally pessimistic or experientially jaded among us may think many of these assumptions are hopelessly naive. However, they are, I think, what many of us hope are true when we sign those complicated forms in a haze of anxiety, desperation, anticipation, and analgesics.

Gordon Bugbee is a member of the Boston-based Community Ethics Committee.

'Bioethics Club'

Who has a keener sense of injustice than the high school student? School teachers know that at this critical time of emotional and intellectual growth, students are often ready to ‘dig in’ to dauntingly complex ethical topics, including those surrounding medicine and health care.

This past year, Aliza Bloostein and Michelle Ryder, two seniors from The Rivers School, a small co-ed independent day school in the Boston suburb of Weston, participated in a pilot ‘Bioethics Club’ program.  The students met weekly with me (a Rivers teacher and Community Ethics Committee member)  to discuss ethical questions arising from such topics as transplantation, vaccination, and medical experimentation. Both busy high school students, neither Aliza nor Michelle was able to fit another course into their packed school schedules, but a weekly club, with a stimulating dose of preparatory reading each week, helped them explore in depth some of the social and moral questions arising from science courses and their science internship experiences. 

With the help of Community Ethics Committee mentors Carol Powers and Paul McLean, Aliza narrowed her research focus to a particular area of personal interest, physicians’ duties to non-compliant patients, while Michelle dived into the wave of current literature on CRISPR gene editing technology. At the end of their year in ‘Bioethics Club’, the students proudly presented their work at the April  meeting of the CEC, receiving warm applause and detailed feedback. Aliza’s and Michelle’s research papers can be found here:

http://www.medicalethicsandme.org/p/student-projects.html

In a separate interdisciplinary course on ethics, other Rivers School students have produced projects designed to engage the wider community in ethical reflection about issues in health care such as concussions, transplantation, opiates, and care for the dying. Some of these student projects can be found here:

http://www.medicalethicsandme.org/p/blog-page.html

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We at the Community Ethics Committee hope you find the work of these engaged, creative students as thought provoking as we all did!

Video: Volunteers speaking for voiceless patients

The Value of Oversight in a Century of Promise & 'Cures'

This post, by CEC member Paul McLean, originally appeared on WBUR's CommonHealth blog.

The blood-thinner heparin is not a 21st-century cure. It was discovered 100 years ago by a scientist looking for something else entirely, and is one of the oldest drugs still in regular use.

After my daughter was diagnosed with a potentially fatal blood disorder, heparin played a key daily role in her treatment. We’d wash our hands meticulously, lay out gloves and antiseptic wipes, saline flushes for the access lines to her fragile immune system, and finally the sealed heparin syringe.

For many months, we went through boxes of heparin and never questioned its safety. Never had reason to.

But in 2008, after my daughter was officially declared cured and we’d used heparin for the last time, contamination in the supply from China killed 19 Americans and harmed many others. Writing that sentence still gives me the chills. My daughter survived thanks to medicine, but it also could have killed her.

So you can understand why, as the 21st Century Cures Act sailed to passage, I experienced both excitement and dread.

That heparin contamination was in part due to lax oversight of the drug supply chain. It reminds me why I do not want to see the work of the Food and Drug Administration compromised by overeager drug companies taking advantage of the hopes of desperate patients, and taking shortcuts on safety.

The “giant piñata” of a bill, as science blogger Derek Lowe aptly described the 21st Century Cures Act, is destined to explode in unexpected ways.

I can’t predict whether it will prove to be mainly a bounty of new treatments, a bouquet of hope for patients, or a lollipop for Martin Shkreli, the hated face of pharma profiteering.

As a medical ethicist, I’m most concerned about this potential fallout: that the FDA will be seen as a barrier rather than a protector, and become too quick with the rubber stamp; and that the DNA of the National Institutes of Health will be edited into a form that diminishes basic science.

And as a father, a husband and a patient myself, I’m most concerned that one day, I’ll ask my doctor, “Is this new drug safe? Is it going to work?” And he’ll shrug.

The act undoubtedly will help with the addiction crisis, improve treatment of the mentally ill, and perhaps move research toward a cure for Alzheimer’s and other brain diseases. That is why it has been championed by the American Psychological Association, the American Society for Human Genetics and the American Society for Clinical Oncology among many others, not to mention President Obama.

But in highlighting the act’s benefits, many of the bill’s backers downplayed its potential harms. Particularly when it comes to the FDA, and the bill’s acceleration of the approval process for new drugs and medical devices.

Is the FDA, in fact, a barrier or a protector? I hadn’t thought to frame the question quite that way until reading about another recent news event. At Standing Rock, in the days before the Dakota Access oil pipeline’s setback, some of people gathered there expressed consternation over the media’s frequent description of Native Americans and their supporters as “protesters.” You see, they perceive themselves as "water protectors."

The 21st Century Cures Act sees the FDA as a barrier to drug makers, blocking the companies' pipeline to patients. What I see is that the agency has long served as a protector — and one thing it has protected is trust in the doctor-patient relationship.

Drugs don’t get approved until proven safe and effective — so doctors know they're unlikely to harm a patient and likely to do some good. Doctors need that confidence in the FDA, but it could be put at serious risk by the act's acceleration of the drug-approval process.

Fueling the bill’s attack on the FDA was an unfounded suspicion that the agency keeps readily available treatments and cures from desperate patients. On the contrary, the FDA has responded meaningfully to the urgency of patients and advocacy groups by creating more avenues for expanded access to experimental treatments.

Still, the 21st Century Cures Act portrays the FDA as too tight, too restrictive. Some backers of the bill portrayed safe and effective treatments as the enemies of compassion. But I worry that choosing that type of compassion over caution can cause harm, both immediate and long-term — to patients and to science alike.

My own bias in assessing the bill can be traced to a cure whose credit belongs largely to the previous century. My daughter had severe aplastic anemia, a failure of the bone marrow that leaves a person defenseless against disease.

There was really nothing doctors could do about it until the second half of the 20th century, when scientists — painfully, methodically — gained understanding of the need for compatible tissues, how to keep certain T cells at bay with aggressive treatment, how to get chemo and radiation doses right, and how to make the donor blood supply safe.

Cyclosporine, which suppresses the immune system, changed everything. In 1983, more than a decade after its discovery in Norwegian soil fungus, it was determined to be safe and effective — by the FDA.

Now, aplastic anemia is often curable, as it was for my daughter. Cyclosporine helped her body make peace with her donor’s stem cells. She benefited not only from emergent knowledge of her rare disease but from myriad clinical trials into other diseases that increased knowledge relevant to her illness.

So when I hear about the billions that the 21st Century Cures Act invests in the “Cancer Moonshot," I know cancer patients won’t be the only beneficiaries. A broader common good will be served, even as individual patients are given new hope and sometimes cured.

But my daughter’s cure was grounded in real scientific knowledge, which randomized clinical trials are uniquely able to provide. And though the 21st Century Cares Act includes $4.8 billion for new research at the NIH, that’s press-release money. The real funding will be determined by Congress over the next decade.

Sen. Elizabeth Warren of Massachusetts, who opposed the bill, warned of its potential systemic harms: “Medical breakthroughs come from increasing investments in basic research,” she said. “Right now, Congress is choking off investments in the NIH.”

My annual physical is coming up. In the past, discussing prescription drugs with my doctor, I’ve never felt the need to ask, “Is this drug safe?” I may need to start. I hope he never answers with a shrug.