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December 8th, 2008
08:55 AM ET
A question of consentBy Caleb Hellerman I’ve been working on a project called “Another Day: Cheating Death” that you’ll hear more about in 2009. It’s about medical innovations, especially in the realm of emergency medicine. When it comes to emergencies, doctors face a dilemma: how do you test a new treatment? Take cardiac arrest: for decades, emergency responders have given victims a shot of epinephrine – adrenaline – to help re-start the heart. But there’s a new study, from Norway, which says the drug actually doesn’t make a difference. How do they know? The only way you can: by testing it. About half the patients, who suffered out-of-hospital cardiac arrest over the five-year study period, got a shot of epinephrine along with CPR and defibrillation. The other half got no epinephrine. None of the patients gave consent to be part of the study. They couldn’t; they were unconscious, and resuscitation efforts had to start right away. The study was approved by an independent oversight board – but when Norwegian reporters found out about this in January, there was a scandal. The doctors were accused of withholding lifesaving treatment. The study had to be cut short, although by that point, it was nearly finished, anyway. Dr. Kjetil Sunde, one of the lead authors, is still upset. He told me, “People only think you’re a good practitioner if you give a lot of drugs. If you just cure him with traditional doctor’s wisdom, they think you’re bad.” It makes me uneasy to think I might not get the “standard of care” in such a crucial situation. At the same time, how else are we going to find a better way of doing things? Would you be upset if you found a hospital had tested a new emergency treatment on you or a loved one, without getting consent? Editor’s Note: Medical news is a popular but sensitive subject rooted in science. We receive many comments on this blog each day; not all are posted. Our hope is that much will be learned from the sharing of useful information and personal experiences based on the medical and health topics of the blog. We encourage you to focus your comments on those medical and health topics and we appreciate your input. Thank you for your participation. |
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You also didn't give consent for the CPR or other emergency treatment. Also, how do you define "standard-of-care"? Tradition does not consist of SoC.
I conduct research in a research 1 university in the US. I am finishing my Ph.D. and do so under the direction of my advising professor. We are bound by strict protocols that would not allow the research explained above to go forward. Our subjects must be able to give informed consent period. This is a very sensitive group. I would wonder how this type of research would receive funding and how its institutional review board (or European equivalent) would let any of this go forward from day one. I cannot do research and then ask for permission later; my plan must be articulated clearly from the beginning with all questions about consent answered prior to receiving IRB approval.
If the experimental treatment was the only chance to save my life, I'd say, "go for it." Just wake me when it's over.
Along the same lines, most of these "new" drugs that come out on the market are really using the general population as guinea pigs in extended studies. Once it reaches a certain level of "safety", it's out there.
After all, how does one really know what the long term effects are (I'm talking years) otherwise?
How does one really know what the effects are on children born to parents who were taking the drug unless you start putting the pieces together over multiple generations?
And it is impossible to predict the potential interactions with other newer drugs unless you give it out to people who are already taking the other drugs.
As for emergency treatments, there really is no other way than to use real patients to test the effectiveness of the new treatment.
The real problem isn't that these treatments are "new" in themselves, it's that the general public mistakenly believes that the so-called 'standard of care' is the only acceptable "GOLD"-standard of care.
It's called medical PRACTICE, not medical PERFECT.
They should allow people to give advanced consent similar to organ donation. If someone is willing to participate in a trial of this nature then they could be flagged as ok to include. It would severly limit the available patients for the study, but it would safeguard both the public and the physicians against such ethical dilemmas.
The difficulties with advanced consent are, unfortunately, many.
1. Very few people have the paperwork on their bodies when they're brought into the ED.
2. Even with organ donation, family members can and do overrule the driver's license organ donation permission.
3. Given the low numbers of people who give advanced consent and who still meet the criteria, studies like the one in Norway would take decades to get to a statistically significant number of participants.
It's a thorny ethical question. But the only way to obtain evidence of whether resuscitation efforts work is to test them out. After all, CPR and advanced cardiac life support standards have changed at least a half-dozen times since I began taking first aid training- all based on best evidence collected from the poor souls who needed them. At some point, you have to revert back to the "implied consent" that is assumed when you find an unresponsive person.
Withholding epinephrine? Come on. Test it on rats first, or petri dishes. Or maybe, they could have first asked a panel of older doctors to be the living guinea pigs, if they'd actually thought the stuff was so "useless". I bet there wouldn't have been many takers!!
I am a bit upset with doctors that are deciding to remove themselves from some forms of care for moral or personal or ethical reasons. Why did they become doctors? I believe doctors that don't want to provide the full slate of care to their patients, they should be shunned by their peers and the public. I would think if they make their living in hospitals that are helped by taxpayer dollars, we the people deserve the care we ask for and want. Become priests and not doctors if you have a problem with providing the care that customers want, that goes for pharmicists as well. So the slippery slope goes....Judy or Joe, the counter clerk at Kroger, decides she or he has a moral problem with condoms, cigarettes or alcohol...It is not their job to pass moral judgement. Every clerk is there to ring up what we want to buy and give it to us. When does the nonsense end. I bet if Judy or Joe did this morality play a few too many times their employer would let them go.
I am not opposed to people advocating for whatever they choose outside of work. When you have a job that serves the public.....guess what, you serve the public. And the public isn't always going to have the same views as their doctor. They (the doctors) aren't there to be a roadblock to the healtcare we would like to receive. That is why they call them providers.
Thanks Sanjay for listening to my rant,
Sncerely,
Brian Kline
I'm upset when doctors push treatments/tests on me and guilt me into thinking I have to consent! If I discovered doctors had tested a treatment on me WITHOUT my consent, I'd be livid.
It's interesting how we're now hearing health care workers push for their right to refuse to administer certain treatments/procedures, yet they're practically programmed from the get-go to get patients to undergo all kinds of sketchy and perhaps unnecessary testing in order to generate profit.
As a result of the complete lack of regard for the autonomy and humanity of patients and the over-involvement of lawyers and insurance companies in health care decision-making, I've sworn off doctors, hospitals, check-ups, tests, etc., for the rest of my life.
No thanks. My body is my body and I have the right to refuse any violation of my person as I see fit. I'd rather die on my own terms, thank you very much.
It may surprise sone that the FDA DOES allow "emergency research" to be conducted with an "exception to informed consent." However, there are very strict guidelines governing how these studies are approved and subsequently conducted. Individual EU countries also have specific guidelines governing "emergency research" and "waiver of consent." The Norway study was actually undertaken under the [then] current country laws.