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Archive for the ‘bioethics’ Category

Am I press?

Having been a journalist in a former life, I try to keep my nose in the game by subscribing to press release services. It’s an interesting way to see the news cycle and journalists’ judgement in action, since reportage from many media outlets can be recycled or augmented press releases.

For the science beat, that means EurekAlert, which is how I got hold of this little gem:

It is about a study to be released in PLoS Medicine which argues we just don’t know if circumcision will hinder HIV transmission rates in the United States. Boiled down, Africa and America are two very different places with very different disease vectors, which means public health data from the former won’t yield predictions about the later.

I got all that from the press release. I haven’t read the paper, which has the following citation:

The reason I haven’t read the paper, and can’t give you juicy quotes (theirs) followed up with bloated analysis (mine)? The press release links to:

PRESS-ONLY PREVIEW OF THE ARTICLE

The all-caps aren’t mine, but they have sufficient emphasis that I gather a hands-off approach is encouraged if you aren’t a journalist.

This brings me to ask the big question which crosses the mind of a serious blogger at least once: Do I count as press?

I could put on my freelancing hat and say, ‘Yes, I am.’ I could even send off an email and ask permission. But that’s just avoiding the bigger question of when a blogger counts as a journalist and is entitled to the same treatment.

My intuition is that anyone who picks up a pen can be a journalist for the purposes of any given story. Amateur or professional, it matters not a whit as long as you behave responsibly. That’s why excluding bloggers from press galleries should rankle everyone – even graduates of journalism school.

I suspect Canadian courts would see it the same way, since they don’t elevate the rights of journalists over those of citizens. Here are two statements to that effect:

Journalists have no more right to information, or to disclosure or even to access to information than the ordinary citizen. Freedom of the press as a concept does not confer any special status on media people. MacLeod v. de Chastelain, [1991] 1 F.C. 114 (F.C.T.D.).

Canadian courts have stated emphatically that the press enjoys no privilege of free speech greater than enjoyed by a private individual and that the liberty of the press is no greater than the liberty of every subject. Coates v. The Citizen (1988), 44 C.C.L.T. 286 (N.S.S.C.). [ed: the irony of the newspaper’s name should not escape us]

Even so, I’ll wait to read the article. Unless the story merits confrontation, a journalist should be polite and err on the side of caution.

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Following the broadcast of The Big Donor Show, which caused much wringing of hands amongst bioethicists and others (including myself), it seems more Dutch are donating organs.

Well done, humanity. It takes a spectacular lie to get us to save lives.

Despite my cynicism, this is good news. More people will live because people donated their organs – whatever the cause.

I still draw the line at rock concerts saving the word, though.

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Before entering law, I wondered what to do with a graduate degree in philosophy. This was at a time when the job market for academic philosophers was not good, and some enterprising students with advanced degrees created businesses involving philosophical consultations for individuals and businesses.

Shades of Monty Python…

Humour aside, there were legitimate worries philosophy counseling occasionally crossed over into territory better dealt with by psychiatrists and lawyers. Absent that training, and a stronger stomach for continental philosophy, I wasn’t about to hang my shingle.

Much more interesting was the way ethics consulting was taking hold in medical hospitals and research centers. This shifted the burden from institutional ethics committees composed of doctors, to clinical ethicists with specialized training in the discipline. It promised the practical application of moral philosophy to real world problems, guided by this injunction:

…the ethics industry needs to be rooted in clinical practice and not in armchair moral philosophy.

Nowhere is that more clear than in a pediatric oncology ward.

It has been over two decades since the introduction of clinical ethics consultations, and the legal implications still remain unclear. However, there has been some discussion of liability in legal and bioethics scholarship. For example:

His conclusion: “don’t give recommendations”.

To which I respond, without recommendations, why bother with an ethics consult? Just saying, “Here’s the ethical map, read it for yourself” only amounts to pointing in the direction of the bioethics section of the library (Dewey Decimal #170). It also promotes a professional moral relativism that confuses patients, and doesn’t say much for the moral convictions of clinical ethicists.

For further reading, with some literature about institutional review boards, see:

  • Marjorie Ellen Zettler. Law and Ethics in Medicine: Trials and Tribulations of the IRB Member. University of Toronto Medical Journal. 80:3 (May 2003) 200.
  • Daniel L. Icenogle. IRBs, Conflict and Liability: Will We See IRBs in Court? Or is it when? Clin Med Res. 2003 January; 1(1): 63–68.
  • Anderlik MR, Elster N. Lawsuits against IRBs: accountability or incongruity? J Law Med Ethics. 2001 Summer;29(2):220-8.
  • Noah BA. Bioethical malpractice: risk and responsibilities in human research. J Health Care Law Policy. 2004;7(2):175-241.
  • Rich BA. Introduction: bioethics in court. J Law Med Ethics. 2005 Summer;33(2):194-7.
  • Forster HP. Legal trends in bioethics. J Clin Ethics. 2000 Winter;11(4):373-82.
  • DuVal G. Liability of ethics consultants: a case analysis. Camb Q Healthc Ethics. 1997 Summer;6(3):269-81.
  • Spielman B. Invoking the law in ethics consultation. Camb Q Healthc Ethics. 1993 Fall;2(4):457-67.

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All 134 chapters of Neuropsychopharmacology: The Fifth Generation of Progress have been made available for download. Two of them concern legal and ethical issues:

The American College of Neuropsychopharmacology also includes in their archive of publications Psychopharmacology – The Fourth Generation of Progress. It has a piece by Lisa S. Parker and Elizabeth Gettig on Ethical Issues in Genetic Screening and Testing, Gene Therapy, and Scientific Conduct.

Kudos to the College and the authors for giving open access to this tremendous resource.

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Via the Neuroethics and Law blog, we have this story:

A Dutch broadcaster will air a show this week in which a terminally ill woman selects a recipient for her kidneys from three contestants, despite government calls for the programme to be scrapped…

She will make her choice based on the contestants’ history, profile and conversations with their families and friends. Viewers will be able to send text messages advising her during the 80-minute show.

“The chance for a kidney for the contestants is 33 percent. This is much higher than that for people on a waiting list. You would expect it to be better but it is worse,” the daily cited BNN Chairman Laurens Drillich as saying.

My first reaction: anger at the shows producers.

Then, my philosophical training kicked in. I wondered…

  1. Is the utilitarian reasoning of the network’s chairperson correct?
  2. What reasoning processes will the terminally ill donor make, and what factors will she consider? Does a single man with no children stand a chance against a married woman with children?
  3. The three candidates have doubtless been screened to make for ‘good television’. They might not be the people at the top of the waiting list. Is jumping the queue immoral? Is it unethical to select on the basis of something other than medical need? How do the screeners justify their choices?
  4. What decision-making processes will the audience make? Will they be emotionally swayed by sob stories? Will they focus on the relative beauty of the ‘contestants’? Their wealth, race, religion or home town? What allegiances will be relied upon, and be considered morally relevant?
  5. What kind of post-decision counseling will be given to those who lose?
  6. Will the terminally donor receive ethics counseling during the decision making, and psychological counseling afterwards when she realizes she has condemned two people to die – just like her?
  7. Would it be ethical for an ethics counselor to participate in this? Conversely, do people trained in ethics have an obligation to call in and offer advice?
  8. Is it ethical for the doctors and hospitals to be involved? Does the medical licensing authority have an obligation to step in and stop the spectacle? How did this survive an ethics review board?
  9. What does the donor get out of this, and does it matter?
  10. Would it make a difference if the donor was not terminally ill?
  11. The Dutch have a new system of public healthcare. Who is picking up the tab for the procedure – the network? Does it matter?
  12. How is the donor’s decision enforced? Is it a contractual arrangement? Could the doctors legally ignore the donor’s wishes? Ethically?
  13. Is all of this this excused if it raises awareness of the problem faced by people needing donor organs, and causes more people to donate?
  14. Why was I so filled with outrage, and why is that anger now muted by thinking about the ethical issues?

Chris and I have poked at the idea of the psychology involved in every-day moral decisions. This is most certainly not one of them.

My sympathies go to the families involved, to those with kidney disease awaiting a transplant, and to the production crews who have to document this tragedy.

Update: CBC News coverage of the story has a partial answer to my 12th question. The decision can’t be enforced.

“A spokeswoman for BNN said that could be no guarantees the donation would actually be made, “but the intention is” Lisa’s donation would be carried out before she died.

That’s because her wish to donate to a particular candidate “wouldn’t be valid anymore after her death” under Dutch donation rules, Marieke Saly said. If Lisa does donate one kidney while living, the other kidney may still be awarded to someone else on a national donation waiting list under the country’s organ allotment system.”

Update: This BBC story suggests the network chairperson anticipated the controversy, when he said,

we are acting in a shocking way to bring attention to this problem.

Update: Kelly Hills at Bioethics.net raises some of the concerns I’ve expressed above:

Are you pretty enough, sexy enough, compelling enough to be picked out of a flood of applicants to receive the chance of care? Will your story win the hearts, minds, and most importantly, votes of the viewing public?

Update: And finally, it is revealed this is just a hoax.

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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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