Privacy

I'm finishing up preparations for a lecture on confidentiality and privacy for my Ethics in the ER course Wednesday, and came up with what I think is a great hook for discussion about a topic that is usually greeted as dry by many in the medical field. Here goes:

Who remembers their online HIPAA training course? If your experience is like mine, the topics of privacy and confidentiality seem like boring topics. This week on the blog, several of you posted very interesting accounts of dilemmas concerning confidentiality. If you didn't get a chance to read them yet, I'd encourage you to do so. So perhaps privacy isn't as dry as I first thought? Let's say you're not convinced by your classmates' challenges.

I'll step back a bit. Our medico-legal system may reinforce privacy as a topic learned by rote and repetition, but it gets a lot more interesting when you consider that this issue is at the core of the arguably most controversial Supreme Court ruling in the last half century. Can anyone guess what I'm talking about?

Roe v Wade was decided not based on statutes governing assault, or autonomy, or even Aquinas' principle of double effect. You couldn't guess that from the expressions, “right to choose” or "right to life."The case was decided on matters of privacy. Roe v Wade held that a woman's decision of an abortion falls well within privacy afforded by the 14th Amendment and the Bill of Rights. And since abortions these days are almost always in a medical setting, it's easy to see how the privacy from the state bleeds into the confidentiality afforded by patient-physician relationship.

If you are in the course and happened to find this post early, consider yourself a planted answer if no one responds to my question!

Virtual Mentor

In the process of preparing for my Ethics in the ER course, I've encountered a number of resources that folks interested in medical ethics may find useful. Every so often, I'll review and link them here. The first feature is Virtual Mentor. This is an online open-source journal published by the American Medical Association as a resource for teaching medical ethics. The content is decided by a panel of resident physicians and medical students with interests in ethics. The outcome is a forum for important conversations about current topics in health care. This month's issue, for example, addresses homelessness.

Each month, the journal posts editorials, literature reviews, policy positions, and my favorite section: case analyses. In general, the articles are interesting and accessible. Contributions are short to medium length, are written by qualified authors, and most of the time include varied viewpoints. The journal exists on a platform that is easy to use with .pdfs of every article and has some extra features like a podcast and a quiz from every issue. I understand that the entire journal will soon be listed in Pubmed. VM also compiles an excellent library of case studies and analyses from each of its issues. If you ever are curious about a particular issue in medical ethics, I recommend you consult this case index first.

Disclosure: I am an issue editor for Virtual Mentor's 2009/2010 year and am looking forward to assembling an issue related to emergency medicine ethics.

Ethics in the ER

This recent Wednesday was the first meeting of the Ethics in the ER course that I am co teaching with Harborview ER doc Stephanie Cooper. Our goals are to expose medical students to how the complex medical decisions made in the emergency department often demand a quick assessment and resolution of ethical dilemmas. The ER (especially in urban hospitals) is one place where physicians will rely on ethical principles every day.

So we've put together a course that features 20 minutes of lecture, 30 minutes of instuctor-led case reasoning, and an hour of student group reasoning. As the class moves forward, we will increasingly role play the fast pace neeed in the ER.

Since I'm a blogger, we're using a blog to enhance learning. If you want to follow along, feel free to stop by and read the students' posts. I'll be posting thinking exercises and links to relevant stories over there every week. There is also a course website, where you can peruse our reading list and syllabus. We're hoping to publish some of our motivations and experiences with this venture, as we are unaware of other efforts along these lines...

Take This Class

Click for a larger image. Email me with questions.

Big News!

One of the things that has been keeping me from posting new entries here is a little project I've been working on for the past 4 or 5 months. Today, I received an email from the chair of UW's Medical History and Ethics department that opened with,

We are happy to endorse the plan for an ER Ethics course as you outline it, and look forward to providing it as an MHE offering.

Whoop Whoop!

I mean, "My, what a fine outcome. I cannot wait to see this effort come to full fruition." Or something.

The bottom line is that back in March, I was in the emergency department admitting a patient to the medicine floor when I ran into an emergency attending who I knew as a sophomore medical student back in what they call the day. We knew each other to be writers, so we caught up about each others' activities. She told me about a cool medical humanities 'zine she was writing a proposal for (since funded!). I told her about my gig at The Differential. And she mentioned an idea for teaching an ethics class based on cases from the ER.

Schreech!!! My mind and body did a double take.

I don't exactly recall what condition the patient I was admitting had, so will take some narrative privilege (and play the statistics) to report that I thought: "the guy with hepatic encephalopathy can wait a few more minutes." In truth, it was 3AM, we had already examined him and written orders and I was checking lab results in the fishbowl (which we call the central command center of the ER) before getting a couple hours of sleep. As usual, sleep takes the back seat.

The bottom line is that sleep was sacrificed for this project more than once. The opportunity to apply what has always been an extra-curricular (or at best co-curricular) interest in ethics to my chosen profession was amazing. As the chips lie today, this winter I'll be co-teaching (with the emergency medicine attending) a class to first through fourth year medical students called "Ethics in the ER." The curriculum is discussion oriented, is based on numerous actual cases, will employ a blog/discussion board and require a small amount of reading from medical humanities and ethics sources.

I think the curriculum we're developing is a unique approach in medical ethics education, and are excited about testing it and reporting our experiences for others to learn from and improve. I am also looking forward to a few more energized late nights turning theory into practice.

Blogging Codes of Ethics

Over the last year, I have grown into the moniker of "blogger." There are many out there who still speak disparagingly of blogs and bloggers. (They are likely not reading this post!) But now that major media outlets all have their own blogs, it is less clear to me that blogging is a fringe activity. In the past month, I have started to think more critically about the blogger's roles of furthering knowledge, sparking conversation and providing venues for personal growth. This was first apparent to me when I started posting about patient encounters. Patient privacy and the law each have something to say about disclosing information related to patients, and bloggers must respect both. That is why I subscribe to the Healthcare Blogger Code of Ethics. Starting today, you will see a new logo in my sidebar referring to that decision.

As blogging becomes more prevalent, and as certain bloggers achieve more prominence, I think it is important for us to address the responsibilities we have as writers and interpretors. My blog is not strictly a science blog; lately it has taken more of a healthcare blog. There are also plenty of entries that hit a little closer to home than some of my readers care for. In the end, in all of my posts, I strive to balance interesting with informative.

I'm still not sure of the precise relationship between blogger and journalist. One of my friends from high school is successful at both. Perhaps more than personal blogging, science and health bloggers are journalists. The blogger's roles as informer are dependent on the same principle as science: truthfulness. The interpretation part of blogging is where truthiness becomes more prominent. Opinions and interpretation occur more in blogs than in the newspaper (aside from the op-ed page), and it is certainly not difficult to see the differences between discussion sections of scientific papers and the lengthy diatribes we bloggers occasionally partake in. Keep in mind that these two are only points along the same spectrum.

Is there a code of conduct that can be constructed for science bloggers? In response to discussions organized by Dr. Free-Ride at the 2008 Science Blogging Conference, she has built a Science Blogging Ethics Wiki where ideas for a code of conduct (including whether there needs to be one) can be bounced around. Three of the main sections of the code that have emerged so far include:

1. Responsibilities to readers
2. Responsibilities to other bloggers
3. Responsibilities to sources

Periodically, I'll be pitching in over there with my ideas. I hope you will, too.

Movie Review: I am Legend

I'm no film connoisseur, but I am a scientist and physician. Well, almost a physician. So it is from a biomedical perspective that I present my review of I am Legend, starring Will Smith. This is the first film I have seen on opening weekend in as long as I can remember, and the first I've seen in a theater since Arctic Tale. This article won't be a true spoiler, but I will address several critical plot elements. Stop reading if you don't want to ruin the surprises. First, it was nice to see the movie without knowing any of the story. (Will Smith got me in the theater.) Other reviews point out Smith's excellent acting, the weak CGI monsters and how much the story strays from the original novel by Richard Matheson. And Popular Mechanics assesses the verity of the 'junk science' built into the plot. I take a broader view. In sum, I was pleasantly surprised that not only was science important to this film, but it was the co-star. Enough with the preamble! Here's the review:

How many times have you seen a cocky scientist on TV extolling the unlimited cures science has to offer society? If you lived in California a few years ago, you probably met professor Irv Weissman and others promising that stem cells will cure diseases. (They were actually just hinting at it, but does that really matter now that CA is well on its way to funding $3 billion of stem cell science?) I am Legend opens with a smug blond scientist admitting on local TV that yes, she has cured cancer. Note #1: Scientists, if you want to get visibility for science, you need to get on the local news! Evidently, this scientist has built a virus that prevents either tumorgenesis or malignancy. Fortunately, the film did not get into that detail, because I would have something significant to critique! What is notable is that the plot plays on the public's lingering fear of gene therapy. And of course, the worst nightmare comes true. The virus mutates into a lethal strain that results in symptoms part rabies, part ebola, part bird flu. The virus first requires physical contact for transmission, but soon aerosolizes and crosses species boundaries. I am skeptical that viral evolution could actually occur as quickly as in the film, but perhaps such a trait is what enabled one virus to cure every type of cancer in the first place.

Speaking of curing cancer, our mad scientist (who had a vaguely European accent), indicated that of 10,009 clinical trials, 10,009 people were cancer free. This is likely a consistency flaw instigated by the script writers, since later, Will Smith's character tests his "compound 6" and calls one experiment a clinical trial. Note #2: A clinical trial includes hundreds, if not thousands of patients. This was a little mistake, but could misrepresent the process of evaluating safety and efficacy to the millions of people in the theater this weekend. By the way, this flaw was my infectious disease researcher wife's biggest beef with the film.

Speaking of infectious disease, we need to talk about immunity. If 1% or the world's population was immune to the film's virus, Manhattan should have been left with 15,000 people. It took 70 minutes or so for an explanation of why Will Smith's character was the only human remaining. It turns out that 30% of those who survived turned into zombies. These (poorly animated) zombies ended up killing the rest of the people. How likely is it that a virus could cause a devolution (or evolution) of humans into zombies? Greg Bear offers a pretty believable mechanism in Darwin's Radio. If this little viral beastie was a certain type of retrovirus, aggressive zombies could be the next step in evolution, and this could even occur in one generation. I am guessing that this is the part of the film that the audience is supposed to suspend its belief about...

What about the basement laboratory? Smith's character used a fancy eyeglass-mounted video camera to record his experiments on various compounds to reverse the virus's symptoms in sewer rats. The writers got some things right here. Only "compound #6" worked; this was one of twenty he tried in this series, in what we assume was a long string of trials. This brings us to Note #3: Only a small fraction of science experiments 'work.' Of note is that only one rat was tested with #6 before moving to human trials! I guess this paucity of pre-clinical data can be excused when civilization is at stake. While we are on the topic of animal experiments, the presentation of animal research in this film was well done. The rabid rats were clearly animated, so no beef could be made about living conditions for real rats (and the fact that they were injuring themselves on the cages). The cages, by the way, were appropriate for animal size and were not overcrowded. Smith's character didn't need to get IACUC approval for his work, but he was mostly in compliance for many rules about animal care. Some notable lapses: no dedicated facility, interventions that were terminal, minimal personal protective equipment.

The treatment of the bench science was appropriate. There were no unneeded CSI-styled eye-candy closeups of pipetting or tube shaking. (You know the shot: when one of the attractive lab techs flicks an Eppendorf tube up in front of his/her face instead of using the vortexer.) This workshop looked like a well stocked lab crossed with an intensive care unit. There were QPCR machines, vital signs monitors (just like those at the UW hospital!), and med supply carts along with an appropriate amount of clutter. Conveniently for the plot, there were also bullet-proof glass doors. Except for the dim lighting, this looked like a great place to do science.

In my opinion, the ethical land mine in this film was not the fact that some crazy scientist unleashed a deadly virus - that occurred off screen. I worried about the ethical use of human subjects. Smith's character has a wall packed with photos of zombies that he unsuccessfully cured of their zombieism. The viewer is asked to overlook the fact that these zombies have the potential to be fully human. At one point in the film, Smith's character reports that these creatures have lost all semblance of human nature. This is a fine trick to make it okay for experimenting on them. (That is how some scientists justify animal research.) However, the observant audience member will note that the zombies have clear emotional responses to stimuli, exhibit abstract planning and operate in a social manner. One (the chief zombie) even seems to show an attachment to the zombie subject Smith's character is trying to cure. Note #4: If a cure occurs only after sacrificing hundreds of zombie-humans, is the research ethical? Is exterminating the zombie way of life genocide?

Finally, over the course of the film, the protagonist shifts from a Christian to an atheist to an agnostic. First, he prays with his family before all Hell breaks loose. Later, he reasons that God would never permit such a catastrophe, therefore does not exist. The final resolution depends on a near-death and perhaps spiritual experience in which Smith's character adopts a perspective that things 'happen for a reason.' I did not appreciate (nor would my atheist readers) how his suicidal ideation occurred in the post-religion period, while the noble savior surfaced after reconsidering a religious perspective. Apart from that flaw, I was pleased that this portrayal of a scientist encompassed religious, agnostic and atheist perspectives, therefore illuminating Note #5: Science can be done by individuals from diverse belief spectra.

In the end, my wife and I agreed that this was an entertaining movie and worth the $8 after a day of studying. The plot was creative enough to get me thinking about some interesting research ethics and science in society issues. Hopefully it got some others thinking as well.

Witnessing Evil?

On November 28 a young man named Dennis Lindberg died in Seattle's Children's hospital. He died because he refused treatment for leukemia. I have personally met many individuals close to this case. I work in Skagit County, WA - the same county where Judge John Meyer made his well publicized ruling. Last week, A Jehovah's Witness who happened to have a deep vein thrombosis taught me about the Winesses' perspectives about blood. His wife shared that she was in the same congregation as this young man. The attending hematologist for this procedure gave lectures about leukemia when I was a medical student at Children's Hospital in Seattle. My wife worked with him for a new diagnosis of leukemia that presented in a kid that came to the Children's ER. I have taken courses with and from some of the professional ethicists on staff at Children's. I would not choose the same path for myself of a child in the same situation, but when you see the story from so many angles, it's harder to be so critical of the outcome.

On top of the complexity already inherent in this case, there are a few distortions, inaccuracies and partial truths about this story gaining traction in the blogosphere - particularly in the atheist community. This post is meant to bring to light some of those lapses in intellectual honesty. We all complain about how science is too-often misused by politicians; when dealing with an issue as controversial at this one, the least we can do is present all of the facts.

Here are some points that if you rely on blogger news, you may not have encountered:

(1) Jehovah's Witnesses were founded in 1872. Any reference to the faith being founded on Bronze Age or Dark Ages thinking is inaccurate hyperbole. The religion is based on 19th Century pre-modern medical thinking.

(2) The treatment denied by the judge was not the stem cell transplant. It was a blood transfusion. Why is this distinction important? Stem cell transplants are the single most expensive procedure in medicine (hundreds of thousands of dollars just to do the procedure). We do them (and many health insurers cover them) because they work, but not all patients facing leukemia choose to be transplanted. Some cannot afford it. Some do not want to go through the pain of the procedure. Others (like this patient) have different reasons. If after providing all of the information, the patient does not consent to a procedure, the medical establishment usually respects this decision. Keep in mind that the legal decision here was related to the blood transfusion which could keep the patient alive for several days, not the stem cell transplant, which has 70% survival at 5 years as reported in the media. It's not as simple as a 750 word article would have you believe. (The Seattle PI printed a good story overall.) The Cheerful Oncologist offers a refreshing perspective on this issue.

(3) There has been some criticism of the words "mature minor." Some say it is a contradiction. The terminology comes directly from Washington State law. Health care providers are very familiar with the term; mature minor is most often applied to pregnant teenagers and to teens who need psychiatric services. The right to make autonomous, confidential (parent-free) medical decisions about reproduction (including abortion) and mental health issues is routinely conferred to 14-year-olds. It has not been previously applied to patients with blood diseases. Joana Ramos outlines some of the issues in a white paper she authored:

Doctrine of the Mature Minor
In most states of the US, 16 is the minimum age for donating blood with parental consent. In a variety of instances, teens are able to consent to, or refuse, medical treatments including surgery. It is customary that 14 is the age of consent for confidential reproductive health services, including elective abortions; substance abuse treatment and counseling; and for consent or refusal of mental health services, even when parents feel that a child’s life may be in danger(1).

The legal concept of the mature minor is well established in case law nationwide(2). It governs such topics the age of consent to engage in sexual activity, to marry, and to make independent and confidential decisions about medical care. The following list of rights extended to teens serves as a good illustration of this concept. Many of these rights involve activities that carry varying amounts of risk, may have both psychological and physical health consequences, and may be neither beneficial nor life-saving. While the laws vary in each state, teens commonly have the right to:

• make decisions as to one’s own guardian or custodial parent at 12
• travel and to purchase a ticket to travel by public conveyance anywhere in the US at age 13 without parental permission
• be employed at 16, but to engage in agricultural work at age 12, in other occupations at 14, with certain jobs being exempt from any age limits
• obtain a license and drive a motor vehicle at age 16
• have one’s body pierced at age 16 without parental consent
• enlist in the military at age 17, with parental consent
• petition the court to become an emancipated minor with cause
• make decisions on behalf of a child parented by one’s self at any age

References:
1. Stenger, RL. ( 1999-2001) “Exclusive or Concurrent Competence to Make Medical Decisions for Adolescents in the United States and United Kingdom”, Journal of Law and Health, 14(2):209-41.
2. Forman, DL. (1998) Every Parent’s Guide to the Law. (pp. 87-154) New York: Harcourt Brace.

The legal precedent in this case is that the 14-year-old was conferred mature minor status for a condition that was not reproductive or psychiatric. In his criticisms of this case, Orac makes the right concession to adult Jehovah's Witnesses regarding decisions about transfusion. He believes a grey area to apply between age 15 and 17. Based on the above examples, I think the range should be 14-17.

(4) Some have written this to be an ignorant backwards, if not abusive decision. To those who think this, I would invite you to seek out a Jehovah's Witness. Ask him about blood. If you don't learn from that individual, every congregation has several experts and health advisers. I bet you will learn things about bloodless surgeries (a few of which are at least as successful as traditional approaches) and artificial blood that you had know idea about.

(5) The newspapers included a fact about this case that most bloggers have left out. The patient's biological parents (who filed the injunction to force the blood transfusion) had a long history of drug abuse. They were in and out of jail, but had been in recovery only recently. They flew to Seattle days before the court hearing and the patient's death. If their son was dying of leukemia, why were they not in Seattle in the weeks and months before this incident?

The bottom line here is that this case is complex. At its center is a 14-year-old's autonomy. Closely related to that is the freedom of religion. The same individuals who value the separation of church and state have called for that wall's dismantling via a court of law. In the end, the judge looked at this young man's ability to make life and death decisions. My suspicion is that Dennis Lindberg was better prepared to make this decision than you or I.

Graduate Ethics Education

This weekend, I'll be heading to Lexington, Kentucky to represent the University of Washington at the National Conference on Graduate Student Leadership. I'm giving a talk about how ethics education should and can be better incorporated into graduate school. I have 8 minutes... Naturally, I'll be speaking a bit about the Forum on Science Ethics and Policy, but I'll also lay out a case for why providing formal and informal training in ethical reasoning makes for better graduate students.

I had hoped to take my new EEE PC, but it seems as though UPS got confused and shipped it to Ontario, California instead of Seattle. I've already weaned myself down to checking email once a day. I think I can cut the cord for a whole weekend...

Ethics of Medical Training Vol. 1

You're a patient at your local university hospital. Chances are good whatever is wrong with you is complex enough that you have traveled further than most people do when they go to the doctor. But then again, maybe you live just down the street! In any case, you come to the UXMC for the reputation, for the expertise, and to get an answer for what is wrong. It's your first visit. You've filled in the forms, the nurse has taken your vitals, and you're sitting in the cold, fluorescent bulb-lit exam room waiting to be seen, and who is the first to walk in? A twenty-something wearing a poorly-fit white coat grasping a clipboard like a security blanket. "Who is this?" you wonder, and "why does he look so nervous?"

Congratulations. You have just experienced a critical component of the graduate medical education complex. Shifting uncomfortably in front of you is the first rung of the ladder known as the medical hierarchy. Immediately you think, "How is this spring chicken going to heal me when all of the other docs were puzzled?" The answer is a little complex.

Hopefully the medical student in front of you is a little more comfortable than the way I've described him. Unless it's the month of July (when all of the residents and medical students are new), the student has already interacted with hundreds of patients, so he shouldn't have problems conducting an interview. At the foundation of your observation is a critical tension at the base of medical education and professional ethics: How are we to balance what is in the best interest of the patient with what is in the best interest of society? A byline of this tension is the medical student's concern about evaluation. While we students should be focusing on doing the right thing for the patient, many of us also want to do the right thing for our grades. That usually means thinking inside the box and being conservative with answers. Such thinking is not, however what doctors usually order at tertiary medical centers, and it's not what you need to solve your problem.

Fortunately, the medical hierarchy comes to the rescue. The residents, fellows and attending physicians who are actually liable for patient care benefit from the constant discussion, questioning and brainstorming (all lumped into that unfortunate term, 'pimping') that a teaching environment affords. You benefit from the system that brings you the medical student.

On a lighter note, keep in mind that medical students usually only take care of 2-3 patients at a time in the hospital. This means that they have more time to sit in your room and ask questions, catch overlooked relevant physical exam findings and pore over books (paper or electronic) to learn about your condition. And if you are a kid, maybe the student will take you over to the playroom to use the finger paints!

In many ways, you are the best teacher for medical students (especially those tired of sitting in class). Thanks for working with the medical student. Society thanks you, too.

Ombudsman

Tomorrow I meet with the University of Washington's ombudsman. Don't worry, it's nothing serious, and is of my own prerogative. If it is appropriate, I will certainly post more specifics in the future.

Just out of curiosity, does anyone out there have any experience interacting with ombudsmen?

Universities have come to rely on this person as a resource for personal conflict mediation and for processing claims of scientific misconduct (neither is the reason I am meeting with her). One prominent use of ombudsmen is the James Sherely tenure dispute at MIT. I also bet that legislation like the Whistleblower Protection Enhancement Act (HR 985) probably comes to bear on this office. The nature of ombudsmen's work is usually confidential, so it will be interesting to learn more about what the office does.

I figure that at the least, I will come away from our meeting with a better sense of how the ombudsman can factor into the academic structure. And maybe by the end of this I will be able to pronounce ombudsman without twisting my tongue.

This Just in From Kansas...

Did you think that the new school board elected last year in Kansas would solve the political dilemmas in that state about evolution and creation? If so, you should reconsider your ideas about the appropriateness of elected officers defining education standards. The political pendulum will always swing, but the recent pass has opened a new can of worms. This time, defenders of evolution must deal with topics that has plagued this debate for a century: the problems of eugenics and social Darwinism.

First, a brief timeline from Kansas:

August '99: Kansas state school board de-emphasizes evolution in science standards.
August '00: Two conservative board members booted.
February '01: Evolution teaching restored.
August '02: Board split 5-5 on evolution.
August '04: Conservative resurgence led by Kathy Martin: Creationism 6, Evolution 4
February '05: Announcement that evolution will be reconsidered.
November '05: Science standards criticizing evolution approved.
August '06: Pro-evolution members regain majority.
February '07: Standards including evolution adopted.

So what's the fuss about?

Well, it turns out that not only is the new school board removing the creationist and intelligent design (ID) material from the science standards, they are removing references to the two most egregious examples of scientific misconduct from the twentieth century. It happens that in November 2005, the standards that inserted ID in the science curriculum, also for the first time included accounts of the Tuskegee syphilis study and Nazi human experimentation. My guess is that these were thrown in as tools to discount everyday science as immoral. In fact, it is the pseudoscience of eugenics that should be criticized! Now ID proponents, including Seattle's Discovery Institute, are using this example of 'censorship' to point out that science education is being improperly sanitized.

So I guess we need to talk about what students actually learn about science in school... Every science student is introduced to the scientific method, but most scientists (and every philosopher of science) who read a high school textbook will agree that the accounts of the history of science are sanitized. It's not really until upper level college courses that budding young experimentalists learn that science is not exactly tidy. Experiments rarely work the way you think they will, and the discoveries that are so succinctly accounted in the textbooks were preceded by years of failure. That does not even touch on the fact that ethics and the responsible conduct of science are hardly ever taught on through the graduate levels. So is it a step in the right direction to include these crimes of human experimentation at the high school level?

I have to agree with these ID proponents that introducing students to horrors conducted in the name of science is acceptable. The examples of Nazi science and Tuskegee belong in science education within the context of learning about the practice of science. A condition of including these accounts should be a proper discussion of the Nuremberg Code and the Belmont Report as efforts to reach consensus on the limits of scientific experimentation.

As a final side note, I have yet to see an account accessible to the public that distinguishes evolutionary biology from social Darwinism and eugenics. Does anyone know of one?

Blinded Controlled Studies

What happens if a blinded investigator discovers something startling while reviewing the information from a clinical trial? Part of enrolling in a research study is that the subject waives his or her access to personalized care. But how do we draw the line?

This morning, I attended a scientific talk that presented data from a clinical study involving MRI imaging of carotid arteries at risk for plaque rupture and embolus formation. (Those events often lead to stroke.) In one case, an individual initially had no evidence of vascular disease, but three years later, showed a considerably more complex lesion in the vessel. The plaque had ruptured and the lipid core was continuous with the blood flow. Theoretically this is a severe risk for morbidity, but the patient had no symptoms. Just for reference, if that type of lesion was found in an autopsy, the cause of death would be immediately settled.

I was surprised to hear that this patient and his surgeon were kept blinded about the condition. Thanks to the research ethics class I am currently taking, I wondered why the patient was not told. (The notoriously cantankerous professor that hosts the seminar did the favor of asking the question I was wondering about!) The speaker replied that no one has any scientific evidence that a lesion like this actually correlates to stroke. Since this MRI technique is new, and it is the first time that such lesions are measurable in vivo, there could be a large number of folks walking around with this type of problem without experiencing a problem. The study is still going on. Do we have to wait for these folks to die?

I wonder if this 60 year old man just happened to be the pilot on my flight home for New Year's, or the guy that drives my bus, or someone's grandpa...