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Archive for the ‘bioethics’ Category

Your loved one has had a heart attack, and is unconscious. An ambulance rushes to your home, and the technician had a choice: start with CPR, or zap the patient with electrified paddles right away.

How would you feel if, at that moment, the EMT flipped a coin to decide treatment?

This type of scenario raises red flags for bioethicists. Add to it that the randomized choice of care is part of a research trial, and it’s not difficult to see the medical intervention as a sinister assault on a vulnerable patient.

There are two big concerns with experimental trials that take place without the consent of critical care patients. One is practical: we don’t want to use experimental therapies that end up being less successful than present treatments. The other is principled: we don’t want to force treatments upon patients. Combined, the objection becomes more vivid: we don’t want to compel patients to risk bad medicine.

If we poke about, there’s another gut reaction lurking in the background. Even if the patient has given informed consent, we don’t like research strategies where patients are just a way to get something else done – a means to an end. It promotes risks we dare not tolerate, and offends the view that we should be treated first and foremost as precious individuals who have interests deserving of protection and care. (A neo-Kantian would toss in the idea of ‘human dignity’, but I’ll give that a pass.)

With this in mind, I’d normally side with the majority of bioethicists; informed consent is a good thing, even though it may have less of a presence in modern medicine than some philosophers might think it should.

However, I’ll depart from George Annas and others quoted in the Washington Post’s item, Critical Care Without Consent. My reasoning is simple, and has nothing to do with the benefits that might come from the study. Instead, it has to do with medical ignorance under conditions where, in at least some cases, informed consent doesn’t matter much.

The controversial research trials by the Resuscitation Outcomes Consortium involve treatments for which there are now only arbitrary choices. This means that right now, there is no such thing as informed consent. Doctors and emergency medical technicians are already flipping coinsand if they weren’t, patients would be doing it for them. When we don’t know what to so, it makes sense to organize and record the many arbitrary choices that are already being made, and learn what we can.

Previous posts on medical decision-making and informed consent:

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What should we make of dinosaur publishers leading the charge against dangerous drugs?

On Monday, GlaxoSmithKline received some bad news about Avandia, its drug for diabetes patients. According to a study in the New England Journal of Medicine, Avandia – Rosiglitazone Maleate – increases the risk of heart attack.

Here’s the report, although readers without medical training may find it impenetrable:

For a measure of the confusion that results from this type of disclosure, see Dr. Charles’ coverage at Unanswered Questions About Avandia & More on Avandia. [Update: see also this Washington Post article, presented as a FAQ.]

This may remind readers of the medical, financial and legal panic following indications that Cox-2 Inhibitors prescribed to arthritis sufferers had serious side effects. The most popular of the Cox-2 drugs were Celebrex (sold by Pfizer) and Vioxx (sold by Merck). Responding to panicking patients, doctors, regulators, and investors, the FDA and Health Canada were quick to issue warnings.

The Vioxx scandal was a natural result of a general failure to regulate drug safety, and there were widespread calls for closer and more reliable monitoring – both before and after their approval for sale by government agencies. The targets for regulatory reform don’t tax common-sense:

  1. the merits of post-market surveillance, including provisional licensing.
  2. the dangers of early pre-market licensing, and
  3. the unhealthy demand created for untried prescription medications by direct-to-consumer advertising.

An editorial from the journal of the Canadian Medical Association nicely summed up the problem, and advocated a sweeping regulatory solution:

The FDA and Health Canada have demonstrated their structural inability to do ongoing safety monitoring of new drugs and devices, and industry is far too conflicted to be able to carry out this important task. We need new national agencies to monitor drug safety independently from the approvals process. Only then can physicians and patients be assured an unbiased safety assessment of the drugs they are prescribing and taking.

Two years later, and very little has changed at either agency. Despite tentative forays in the US Congress, and ‘critical path‘ talks at the FDA, no legislation has been passed which would respond to the problem. In Canada, discussions about progressive licensing have yet to assume regulatory force, and there are indications the situation will become worse, not better.

The most significant development has come from member journals of the International Committee of Medical Journal Editors (ICMJE), who issued a statement declaring they will only publish trials previously registered with ClinicalTrials.gov, a database hosted by the National Institutes of Health.

Soon after, the ICMJE adopted recommendations of the World Health Organization, in part to counter Big Pharma’s attempts to circumvent their requirements.

This is a story with enough alarm and money involved that it has gained significant attention. But unlike the Vioxx ‘fallout’ story in 2004, this story is made new by an extra twist. Major newspapers are framing it as a triumph for open access to information.

Each of these focus on how Nissen and Wolski used information culled from GlaxoSmithKline’s own public database, the Clinical Trial Register.

This story works. It has a personalized David and Goliath theme that invites schadenfreude when a large drug company is caught by its own data.

I worry, though, that this will create confidence in informal drug monitoring that relies on whistle-blowing by objective and motivated researchers and medical journals.

It’s already happening.

Joe Weisenthal at Techdirt, floats the idea that medical journals could replace the FDA.

Looking down the road, one could envision a system whereby it’s the FDA’s job to ensure that drug companies properly report safety and efficacy data, while third parties (think highly specialized versions of Consumer Reports) make judgments on a drug. Then, instead of having blanket pronouncements on whether a drug can be sold or not, it would be up to doctors to weigh all the risks and decide what’s best for their patients on an individual basis.

This a dangerous and naive view of informed medical choice. Front-line physicians don’t have the time, resources or skill to mount strict, comprehensive and authoritative analysis of drugs. GlaxoSmithKline’s Rosiglitazone Studies are no good to your family doctor. Moreover, doctors are swayed by drug marketing and browbeaten by patient advocating specific treatments.

Even worse, we can’t rely on uncoordinated third-party research specialists to study all of the effects of medicines that go to market, and we can’t rely on peer-reviewed journals to publish only good results.

Open access to the data is a good idea, but it is not enough. Public health cannot take place voluntarily or in a legal vacuum. We need regulation to enforce that open access, we need regulation to uncover harmful effects and screen for snake-oil ‘alternative therapies’, and we need regulation to free doctors and patients from biased sales pitches.

Absent this, informed choice about medical treatment is a myth.

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Following a paper published in Fertility and Sterility, the New York Times weighs in with this: As Demand for Donor Eggs Soars, High Prices Stir Ethical Concern.

The surprise for me was how Hastings Center ethicist Josephine Johnston characterized the problem: she thinks the lure of a big payment can cloud informed consent.

The real issue is whether the money can cloud someone’s judgment… We hear about egg donors being paid enormous amounts of money, $50,000 or $60,000… How much is that person actually giving informed consent about the medical procedure and really listening and thinking as it’s being described and its risks are explained?

Informed consent can’t happen when a lot of money is involved? Johnston’s assumption needs empirical evidence to back it up. Is it true that women are so tempted by money they become incapable of making an informed decision?

Informed consent is a legal concept, so its meaning varies by jurisdiction. However, at its core it involves the subject of a medical intervention only agreeing to the procedure after considering its purpose, risks, benefits and uncertainties – and the availability of alternatives.

It’s something you’ll almost never see in medical dramas like House, where doctors  – not patients – make the decisions.

There are occasions when people are believed to be incapable of providing or withholding informed consent. This happens when patients are unable to make judgements about their care, either because of immaturity, cognitive infirmity or duress.

Since youth and mental health are not at issue, perhaps Johnston is thinking about duress. But since when is a profit incentive equivalent to duress? Where are the women held to ransom by student loans, who feel bad about selling eggs but do it anyways?

While it may be common for us to think that decisions we would not make signal an inability to make informed judgements, the question of a patient’s capacity to consent should have nothing to do with whether or not we think the decision is a good one.

A principled approach also recognizes the type of procedure should make no difference at all to the measurement of a person’s capacity to give informed consent. This just means that if a person is capable of giving informed consent for one medical procedure, they are capable of doing so for any. The stakes don’t matter. A woman who can give informed consent for a vaccination can give or withhold informed consent for a kidney donation, sex change, blood transfusion, or for-profit fertility treatment.

Also, why shouldn’t people consider facts external to the medical merits of a procedure? How does this threaten informed consent? Consider the following examples:

  1. When a person worries that they might lose their job if they don’t undergo a procedure, does this mean they lose the capacity to make informed consent?
  2. When a person is worried they might lose weeks of work if they undergo a procedure, does this mean they lose the capacity to withhold informed consent and refuse treatment?

Keeping in mind the second example, consider how nobody would question a woman’s capacity to consent if a she decided to not donate her eggs because it cost her too much time and money.

How can it be that women lose the capacity to make or withhold informed consent when they think about monetary advantages, but keep their ability to decide when they think about monetary disadvantages?

The lesson we should take away from this is simple: the capacity to give or withhold informed consent doesn’t go away when a person has access to extra information about incentives and disincentives.

If there are good objections to the sale of human eggs, they don’t have anything to do with informed consent.

(Hat tip to Pure Pedantry for mention of the NYT article. However, he is wrong about the law in Canada and the UK. In both jurisdictions, egg sales are illegal. In Canada, it is a serious criminal offense to buy human eggs. In the UK, while egg sales are illegal, donation with some compensation is permitted.)

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Today, two articles from the Washington Post tell us how economists and doctors are using behavioural psychology to make the world a better place.

The first involves the use of intuitions in making public policy – while my own research interest concerns the involvement of moral intuition in political and legal decision-making, scholars of behavioural law and economics are fascinated by intuitive calculations of costs, benefits, risks and distributive fairness – among other things which challenge the assumption of rational economic actors.

Paul Rubin says evolutionary psychology can tell us when politics goes off the rails due to errors in ‘folk economics’ – which he defines elsewhere to be “the intuitive economics of untrained persons.”

Public policy pays surprisingly little attention to evolutionary psychology. Yet there are many human intuitions and behaviors that influence contemporary policy issues — sometimes in ways that are no longer useful or perhaps even harmful to humans flourishing. These intuitions are sometimes referred to as “folk economics,” and one area in which they often emerge is the international economy. [emphasis added] …

As products of evolution, humans cannot help but be born with certain biases. But we are not condemned to this evolutionary programming; we can identify the biases and recognize when they lead us astray in the modern world.

I don’t know why it should be surprising that public policy ignores evolutionary psychology, but I do agree that we are better off when we know intuitions are misleading us. How this can be practically applied to winning policy arguments remains an open question. Telling someone they are being misled by their evolutionary origins is bad rhetorical strategy – particularly if your opponent doesn’t think much of evolution in the first place.

The second article is a piece on the usefulness of body language training to doctors. The sell: presenting appropriate cues helps create a rapport with a patient, builds trust and fosters communication, therefore aiding diagnosis and saving time.

The two stories offer very different ideas about why we should learn about the implicit reasons for our behaviour:

  1. An economist hopes education about the evolutionary source of bias will strip away irrationality in discourse. Opting out from aspects of our human nature allows us to excise cognitive disadvantages.
  2. Doctors are being taught techniques to benevolently manipulate patients. Opting in to aspects of our human nature allows us to take advantage of behavioural cues.

I’ll go out on a limb and guess that opt-out strategies are less successful than opt-in strategies. It’s easier to take advantage of human nature than it is to escape it.

Sometimes, we might not even know when the implicit causes for our behaviour are good for us, and whether we should opt-in or opt-out. For an example of this, take a look at a recent study which invites the question: Is it a good thing when researchers implicit ethical values guide scientific studies?

The authors argue value judgements are unavoidable and essential to good epidemiological research.

Scientific training should prepare scientists to engage in ethical reasoning not only because it will make them more responsible human beings, but also because it will make them better scientists.

It makes sense that if there are epistemic benefits to having research methodologies guided by implicit ethical judgements, we should opt-in. It remains to be seen, however, whether there are genuine scientific advantages to implicit ethical judgements. The authors acknowledge this when they mix their opt-in conclusion with an opt-out qualification, and say researchers’ implicit ethical judgements need to be exposed to critical assessment. Either way you spin it, though, ethics training for medical researchers is a good thing.

For more discussion of that paper, see the commentary:

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The National Human Genome Research Institute has an excellent compilation of legislative information related to the passage of the Genetic Information Nondiscrimination Act (GINA 2007). It includes webcasts of testimony, a useful chronology, and links to the Library of Congress archive of legislative information – THOMAS – which uses an interface that Canada’s Library of Parliament would do well to emulate.

The full title: A bill to prohibit discrimination on the basis of genetic information with respect to health insurance and employment.

The merits of the legislation aside, am I the only one that thinks ‘nondiscrimination’ is a clunker of a word?

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