Monday, September 27, 2010

Embrace your Autonomy (Marin IJ)

Earlier this season on AMC’s popular drama Mad Men (a series set in the 1960s), a character named Anna is diagnosed with terminal cancer. When viewers see her, the disease has invaded and fractured her leg and, we’re told, she has only a few months left to live. Anna, however, is blissfully unaware of her condition – she believes that in a few weeks she will be dancing again. How can an independent middle-aged woman be diagnosed with cancer and not be aware of it? In this instance, it’s because her sister and doctors have agreed that it is in Anna’s best interest not to know.

When series lead Don Draper learns of the situation, he is, at first, furious. “I'm here now,“ he tells Anna’s sister, “she's going to see some real doctors, and she's not going to live in the dark."

"You have no say in the affairs of this family," the sister replies. "You're just a man in a room with a checkbook." Ultimately, Draper decides to honor her request to "do the decent thing" and leave before he reveals the diagnosis.

Pretty shocking, isn’t it? Could you envision this “decent thing” happening to you? I should hope not. Most readers would agree that it is intrinsically wrong for a physician or family member to decide what personal health information is “good” for an independent adult to know. But, just fifty years ago, withholding health information was standard practice. What has changed? Respect for patient autonomy.

Patient autonomy is one of the four core principles of medical ethics – famously articulated by Justice Benjamin Cardozo in 1914. “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” But, as accurately portrayed in Mad Men, this basic principle was not widely accepted until the last half century. Before then, there existed a quaint and persuasive notion that doctors were best equipped to make decisions about what information was healthy for their patients and what was not – just as a parent would do with diet choices for a young child. The transformation from a paternalistic, “we know what is best” approach to an autonomous approach was spurred not just by the words of Justice Cardozo, but also by revelations about unethical medical studies (including the “research” atrocities committed in Nazi Germany and the infamous Tuskegee (Alabama) syphilis studies in which infected African-Americans were neither told their diagnosis nor offered treatment.) These abuses made the critical weakness of paternalistic medicine – the potential for abuse in the name of another’s best interests – unmistakable and unacceptable. Nowadays, a competent patient cannot receive a medical intervention or participate in a research trial without autonomously giving “informed consent.”

So, what do you, as a patient or a potential patient, need to know about protecting your autonomy and giving informed consent? Well, let’s consider an example; a common operation like an appendectomy. Before your surgeons can proceed, they must explain to you the procedure’s risks (bleeding/infection), benefits (avoiding appendix rupture), and alternatives (wait-and-see approach). Then, they will have you sign a document to prove that you have been informed and given your consent. What they won’t necessarily do is ensure that you have understood all the details. Studies have demonstrated that, in general, patients’ understanding of consent information is spotty at best – a survey of people involved in a clinical trial of a cholesterol-lowering medication found that only 31% could name the main side effect of the treatment. How informed is your consent if you don’t know what side effects to look out for?

The burden of understanding your medical care does, I’m afraid, fall primarily on you, the patient. And a critical component of this understanding is considering what information is of particular importance to you. The legal standard for disclosure of information is based on what a “reasonable” patient would want to know. But I suggest that your personal standard be your response to a friend’s query, “What the heck is it they want to do to you?” When it comes to an appendectomy, there may not be much variance in how people respond. That may not, however, be the case for other medical tests or interventions.

What about a blood test that could determine if you’re at risk for developing dementia at a young age? This type of test doesn’t exist, but if it did, would you take it? How important would its accuracy be to you and what percentage of “false positives” could you live with? Of course you’d want to know if there were risks involved. But also consider the ramifications of being told that your productive life will be cut short by twenty or so years. Making a choice about whether to know that or not is a very personal calculation. Is this information you would want to know, or is this a case where ignorance is bliss? In this day and age, your doctors cannot withhold a diagnosis of cancer from you, but they may someday be able to offer you a test that predicts your risk of cancer. How much would you want to know? Even if you are young and healthy, it’s never too early to think about what you’d do – or want done. Medical ethics can be sticky, informed consent can seem esoteric, but it’s your consent regarding your health. Embrace your autonomy.

Wednesday, September 22, 2010

Is Smelling Like a Fish Still Worth It? (Marin IJ)

Fish oil has become a popular dietary supplement – one endorsed by cardiologists, Consumer Reports and this column. It contains marine omega-3 fatty acids, known to biochemists as docosahexanoic acid (DHA) and eicosapentaenoic acid (EPA) that are thought to have beneficial anti-inflammatory and anti-clotting properties. But over the last six months, the safety and effectiveness of fish oil has been questioned, leading some to wonder… has the era of fishy burps come to an end? Could it be that the purported benefits of mackerel are actually baloney?

This past March, a group of plaintiffs, including the Mateel Environmental Justice Foundation, filed suit against five manufacturers of fish oil supplements – contending that the products contain levels of polychlorinated biphenyl (PCB) that are above California’s “safe harbor” limit. PCBs (for those, like me, who have a hard time keeping their environmental toxins straight) are industrial chemicals that take an extremely long time to degrade in the environment. Although they used to be widely used, PCBs are now banned. They’ve been linked to cancer (in rats) and to a number of other health conditions. The plaintiffs based their complaint on tests they’d performed themselves – by puncturing fish oil capsules and studying their contents. Their suit alleges wide ranges in PCB concentrations – with some products being well above the reportable level (90 nanograms a day). "The people buying these fish oil supplements,” attorney (and plaintiff) David Roe said “are not being told the PCBs are there." This legal announcement, and the accompanying press coverage, scared the fish oil right on out of some folks.

Then, just last month, The New England Journal of Medicine published the results of a Dutch study (the Alpha Omega Trial) that followed patients who’d previously had heart attacks and who were taking omega-3s (in the form of margarine fortified with marine and/or plant fatty acids). The study subjects (all on standard heart medications such as aspirin) were given small tubs of margarine – with or without different formulations of omega-3 fatty acids – and their intake was tracked by measuring the amount of unused margarine at 12-week intervals. The study followed nearly 5,000 patients for forty months and found no difference in “major cardiovascular events” (such as repeat heart attack or stroke) or in death rates between those who were and those who were not taking omega-3s of any type.

For fish oil advocates, this seems discouraging. And, if you factor in environmental concerns about over-fishing, perhaps it is time to re-consider fish oil. But wait, before you toss out those omega-3 soft gels and discontinue fresh fish Friday dinners, consider some additional perspective.

First, regarding PCBs, there are several reasons not to get too freaked out.

1) No one really knows how dangerous PCBs truly are. Numerous studies have failed to link PCBs to cancer in humans (rats are a different story). And while there is no good data on what a safe level of PCB exposure is, the California reporting limit is far below federal levels.

2) Previous, more comprehensive, studies of fish oil supplements have found limited contamination with heavy metals or PCBs. This is not to say that there aren’t outliers, but the vast majority of fish oil supplements likely contain less PCB than fresh fish or meat.

3) The brands with high PCB levels named in the recent lawsuit are predominantly cod and shark liver oil products. The liver, as you probably know, processes chemicals, meaning that oil from the liver is more likely to contain detectable levels of PCB. Perhaps, and I stress perhaps, it is better to avoid fish liver products.

In my opinion, recall the maxim “the dose makes the poison” and don’t be majorly concerned about PCB toxicity in your fish oil. But, what if, as the Alpha Omega Trial suggests, marine omega-3s offer no beneficial health effects? Well, that would be a different story. There are several reasons, however, to doubt this conclusion;

1) The Alpha Omega Trial, despite being a well-designed prospective study, has some weaknesses. These include the forty-month follow-up time – which does not give us a good sense of long-term events. Second, this study focused on a group of patients already on state-of-the-art cardiac treatment. Third, there is the choice of omega-3 delivery. Dr. Alan S. Go, a senior cardiovascular researcher at Kaiser-Permanente, told me “The choice of putting these agents into margarine was rather curious, especially given that the trans fatty acids in margarine are cardiotoxic and perhaps could have blocked any potential beneficial effects.”

2) Multiple previous studies have suggested an array of protective effects from omega-3s – particularly marine omega-3s. These benefits are not restricted to those people who have already had a heart attack – and it may be those at risk are more likely to benefit.

Where then, does this leave us? Well, as is often said in science, further study is necessary. But, Dr. Go and others are still on board the omega-3 boat; “the overall preponderance of evidence supports the efficacy of marine omega-3 fatty acids for reducing cardiovascular events and arrhythmic events - in selected populations - and the benefits of eating more fish with higher omega-3 levels likely outweigh the risks from contaminants (at least currently)."

This doesn’t mean I recommend fishy omega-3s for everyone, but those at risk should consider them (either via diet or supplements). If in doubt, talk to your doctor. I, for one, am not giving up Kirkland Signature soft gels just yet. Given my family history of heart problems and hypertension, I am willing to risk a few nanograms of PCB for a potentially healthier heart; I just hope my wife is willing to risk the olfactory offense of an occasional fishy burp.

A Contested Illness (Marin IJ)

Some years ago, a sinewy chap sought my help for an aggravating condition. This young man was convinced that microscopic bugs were crawling over and under his skin. You can imagine how horrible this creeping sensation would be and it had driven this guy to a frenzy of restlessness. His arms and legs were covered with excoriated sores and fingernail-induced streaks of scarlet. I inspected him from head to toe and couldn’t find evidence of insects or parasites. Then, as I silently puzzled the situation, he handed me a smudged envelope and asked me to carefully look inside. I removed a half dozen pieces of scotch tape, each holding a spattering of blackish specks. These specks, he declared, were the bugs that were tormenting him. I was doubtful, but nonetheless took a close look under a microscope. And while I didn't see signs of movement or anatomic structure, I wasn’t sure what the specks were or where they’d come from. After several minutes of debate, during which my patient wanted answers and I challenged his theory but failed to offer an alternative explanation, I noticed something. His fingernails were crusty. Along the nail bed and under the nail tips I noticed a blackish substance that looked like..."Are you a painter?" I asked him. Well, indeed he was, and it seemed clear to me that he was mistaking paint chips for parasites. But, he remained dubious. I thought he probably had a psychiatric condition called "delusional parasitosis;" he was certain that he had a treatable infestation.

Years later, I wonder whether this patient and I were meeting at the intersection of a contested illness known (to some) as Morgellons syndrome. You may have heard of Morgellons before; it received some media attention around the time that the Centers for Disease Control and Prevention (CDC) announced they were partnering with Kaiser Permanente to study the syndrome. But more on that later. First, what exactly is a “contested illness”?

To define “contested illness,” let’s start with the concept of “medicalization” – the process by which aspects of the human situation are described and treated as medical conditions or illnesses. For example, bad breath is diagnosed as “halitosis”, and excessive sweating transforms into “hyperhidrosis.” Writes Dr. H. Gilbert Welch in an LA Times editorial: “Everyday experiences get turned into diseases, the definitions of what (and who) is normal get narrowed…we doctors feel increasingly compelled to look hard for things to be wrong in those who feel well.” Lately, the medicalization of society has been driven forward by several dynamics. These include the insatiable market and marketing of personal health and beauty products, and the Internet-enabled organizing capability of condition-specific support groups. When advocacy groups (arguing that they are suffering from a treatable medical condition) collide with skeptics within conventional medical institutions, the result is a “contested illness” such as Morgellons.

Nearly ten years ago, biologist Mary Leitao’s s two-year-old son developed a strange skin condition. He scratched at himself incessantly, creating sores that, upon close inspection, contained bundles of multi-colored fibers. The physicians Leitao consulted were either baffled or skeptical. Frustrated, Leitao set out to educate herself and, in the process, discovered that her son’s symptoms had been described before, as far back as the 1500s. In fact, she found a name for the problem in Thomas Browne's A Letter to a Friend (1690). The letter described a "distemper of children... called the Morgellons, wherein they critically break out with harsh hairs on their backs." Determined to help her son and others like him, Leitao created the Morgellons Research Foundation and its website to disseminate information about the condition. She was surprised when thousands of strangers with similar symptoms contacted her. Pretty soon, Mary Leitao’s frustration had transformed into an advocacy movement. But, experts in dermatology and psychiatry were not convinced – the overwhelming opinion from the medical community was that Morgellons was a variant of delusional parasitosis – a well-described psychiatric condition. According to dermatologist Norman Levine (quoted by Brian Fair in his recent article in Sociology of Health & Illness), “[Morgellons] is not a mysterious disease…If you polled 10,000 dermatologists, everyone would agree [that Morgellons is Delusional Parasitosis].”

As Morgellons became more contested, the CDC, at the behest of some members of Congress, got involved. The CDC chose a middle ground in nomenclature – calling the condition “unexplained dermopathy,” and partnered with Kaiser Permanente to enroll and study patients suffering from “…symptoms including crawling, biting and stinging sensations; granules, threads or black speck-like materials on or beneath the skin; and/or skin lesions…”

And so here we are, several years later, waiting for the results and a peer-reviewed publication. The CDC website states that data collection for the study (which included skin samples from affected patients) is complete and under review by an expert panel. A press officer at the CDC confirmed this status (an inquiry to the Morgellons Research Foundation was not answered).

Whatever the CDC reports, in my opinion the Morgellons story illuminates two distinct points. First, patients’ symptoms should always be taken seriously and symptomatic treatment offered if available. In the case of Morgellons-type symptoms, this means a thorough exam to look for an explanation and (at a minimum) recommendations to alleviate symptoms (such as hydrocolloid dressings, low-dose steroid creams and anti-itching medications). Second, the medicalization of the human condition contributes to the development of contested illnesses and this is not healthy. Is Morgellons the medicalization of a psychiatric condition or is it an unexplained illness? We don’t know. But while it is clear that those with an “unexplained dermopathy” do not feel well, it is also very unclear whether modern medicine is capable of a definitive solution to their problem.

Whatever the answer to the mystery of Morgellons, the dynamics that have made it a contested illness are not going away. I have a feeling that those dynamics will be bugging us for some time.

**Dr. Ballard is not a part of the Kaiser Permanente team involved with Morgellons research.