Do Today’s Medical Ethics Prevent New Breakthroughs?
It is doubtful whether, if current ethical standards, such as those governing informed consent, had existed in the past, medicine would have made much progress. The idea that patients had to consent to experimental treatment did not occur to Edward Jenner, the discoverer of vaccination, for example. He just went ahead anyway. As for the discoverers of anaesthesia, their lack of experimental precaution would nowadays have landed them in gaol.
Circumstances alter cases, however. The thread by which human life hangs has become distinctly thicker in the last century, and therefore the premature loss of life seems anomalous. The more life we have, the more precious it seems to us, or at any rate the worse the loss of it.
Medical ethics, then, have of necessity changed with the times. A recent editorial in the New England Journal of Medicine discusses the ethical problems of studying the safety of new drugs once they have been licensed for use and marketed.
Because of doubts about the cardiovascular safety of a new drug, rosiglitzaone, used to lower the blood sugar in Type II diabetes, the Food and Drug Administration ordered that a trial comparing its side-effects with those of a similar drug, pioglitazone, should be conducted. Critics of the FDA argued that enough was already known about the harms of the drug to withdraw its license or at least limit its use; but the FDA thought otherwise.
Such a trial gave rise to an ethical problem: what to tell the patients taking part in it? The problem was that those patients ascribed to the drug suspected of being more dangerous were not expected to derive any benefit from it; at best, the drug would prove as safe as the control drug, and therefore fail to do them harm. But who would agree to take part in such a trial if informed that to do so could only do him harm, not good? The fact that he was thereby helping to answer an important pharmaceutical question, and thus adding to the public health, would hardly console his widow, or him. Yet the FDA needed a definitive answer, for to ban a drug on a mere suspicion, when a company had invested billions of dollars in its development, would appear arbitrary.
The editorial mentions a practice of the pharmaceutical companies that appears to me natural (that is to say in accordance with human nature) but dishonest. The companies commission several, or many, controlled trials of their new drugs, but when it comes to publishing the results have hitherto been allowed to publish only those that are favorable to their products.
It is massively dishonest, it is scientifically invalid, and even worse is their (lack of) reporting of side effects during tests, they (intentionally) manage to lose the significant ones in the noise of random and placebo effects.
And yet, what can they do? The process is already difficult and expensive, and this is just what you are complaining about in the title. More rigorous, accurate science would multiply the cost and risk yet again. Here’s what I am afraid is the bottom line, human capabilities in science, simply do not allow for “better” process.
I’ve been watching the flow of the “biotech” cures for the auto-immune conditions over the past fifteen years, among others. Some good ones made it through, as did some bad ones, and the available ones all cost $10k++ a year, though I presume the actual manufacture cost is probably trivial, the rest is recovering the development costs for the drug itself and for the nine failed efforts. After watching this up close, no sane person would argue for looser controls, yet cost does not allow anyone to argue for tighter controls.
Um, what was the question, again?
” The process is already difficult and expensive, and this is just what you are complaining about in the title. More rigorous, accurate science would multiply the cost and risk yet again.”
Another aspect of this is the time involved in doing all this testing. Someone could discover a cure for, say, Type 2 Diabetes or AIDS or cancer today that seems 100% effective and has no apparent side effects whatever. But a great many people would continue to die of the disease for many years to come because it takes not just millions or billions of dollars to do the testing of the drug, it takes many YEARS to complete all the tests and have them evaluated.
How would you like to be a person suffering (and maybe dying) from a disease, hear about an amazing cure, and know that it will take 15 or 20 years before the bureaucrats will allow it to be used? How would you feel about being the researcher who made the discovery and know that it won’t help anyone for many years to come?
I understand that the objective here is safety but I can’t help but wonder if the testing requirements for new medications are not excessive. Pharmacology is not my field so I’d be very interested in hearing from someone in the field: is the testing important and meaningful and effective in finding safety problems? Or are they really just an exercise in governments being seen to do good by caring for citizens while enforcing excessive and pointless tests that don’t find safety problems?
Also, do experts in the field see ways to streamline the testing to get the same comfort level with safety but obtain it in dramatically less time?
Take a gander at lunatics like atheist “super genius” Richard Dawkins and his ilk who think it should be OK to kill toddlers (since they’re really not any more human than a fetus).
Will future generations look for cures for anything that ails a fetus or newborn? Why bother? If they’re defective, just kill ‘em and try again.
But of course the problem isn’t the ethics–it’s the government, the tort bar, and the national loss of common sense.
Exactly
The cost of new medications and treatments would become lower if society was more willing to except uncertainty and the possibility of “new thalidomides” that go with it.
It would require a fundamental re-think of the legal environment surrounding medicine to bring it about however.
Having said that, those at death’s door would be willing to role the dice if the possibility of a cure or at least more quality time here on Earth was on offer.
As an RN I am quite shocked and a bit disgusted that this article is written by a physician. Over the years I have been a nurse medicine has moved much closer to evidence based therapy, which as a side benefit has helped ensure some sloppy or in some cases, disinterested physicians, from harming their patients. Some physicians still refuse to use clinical pathways because it is “medicine by cookbook” regardless of the studies that show benefit of following pathways for particular illnesses. A physician can always tweak pathways for individual patients as needed.
Medicine as a whole has had incredible difficulties with paternalism, and the ability to treat their patients as more than children who simply need to do what they are told and not to ask too many questions. Do I sound a little cynical? Perhaps it’s because of the 20 plus years I have seen it over and over and over. It is the rare physician who educates the patient, that job is done primarily by nurses. If I had a dollar for every time I got an order to get consent for either a procedure or a surgery, but that the physician has not even spoke to the patient regarding either, I could retire right now.
What right does a physician or a pharmacy company have to play with the lives of their patients? Large swaths of physicians at the highest educational levels supported eugenics, both in physical medicine and psychiatric medicine, as did large numbers of early nurses, including those who put together educational programs for nurses. Did we not learn anything from that for God’s sake?
Once upon a time it took almost nothing to become either a nurse or a physician except to hang out a shingle, should we return to that in order to deal with the coming tide of not enough physicians or nurses to deal with the aging baby boomer population? The comparison makes as much sense as the comparisons in this article.
I rarely comment, mostly I read here and find what I read interesting and well researched. This article however is so off putting that commenting is necessary. Why bother with informed consent, just do what you want to the patient, after all it MIGHT be for their own good. Or not.
“Over the years I have been a nurse medicine has moved much closer to evidence based therapy, which as a side benefit has helped ensure some sloppy or in some cases, disinterested physicians, from harming their patients.”
So now the “system” will be harming the patients, and that makes all the difference–individual initiative is suppressed, and accountability diffused.
“A physician can always tweak pathways for individual patients as needed.”
But not and expect our now explicitly national and socialist medicine program to pay for it.
“It is the rare physician who educates the patient, that job is done primarily by nurses.”
And as the ability to make a loan servicing margin, never mind mortgage paying profit, on a patient diminishes, doctors need to see more patients in a high speed, low drag fashion, which means they see a lot more and customize a lot less. Nurses already have a place in the economy entirely unjustified by their schooling and general competence–they have all the problems doctors do–the licensing laws need to be relaxed so there is a lot more competition, and admission to practice by apprenticeship and testing in. Licensing by ability to do the job, not the possession of artificially scarce credentials.
“What right does a physician or a pharmacy company have to play with the lives of their patients?”
They are commanded to do so by the iron laws of economics. We have long since past the point where we needed the option legally to take a higher risk at a lower cost.
“Did we not learn anything from that for God’s sake?”
I think you didn’t. They problem isn’t what the government is commanding, it is that it is commanding.
“Why bother with informed consent, just do what you want to the patient, after all it MIGHT be for their own good.”
There is nothing in this article which suggests informed consent should be dispensed with. I suggest you reply highlighting any words which you think do that. This article decries the fact the patients were never given the option–my impression is the prospective study in question was not conducted–and the future studies which will not be conducted, and the future advances not made.
You claim to be for evidence based medicine, when this article decries the fact current and proposed policies will lead to less evidence being collected.
I am sure Dr. Dalrymple is for discovery in lawsuits, where required, and that all should be revealed; and that no tort reform should apply to cases where medical providers have concealed information which would lead people to decline the products of those companies.
Why yes, lets allow “the iron laws of economics” dictate your health care. With that type of thinking from so called conservatives we might as well ready the death panels ’cause the coming onslaught of demographics is going to dictate the need to control costs. Just the iron law of economics, don’ t you know. Oh wait, there’s already a part of Obamacare yhat will set up a panel that will make your decisions. I suppose then you support that. Iron law and such that should control medical ethics.
So you imagine government can repeal the iron laws of economics then? No, it will be the government with the death panels, they’ll have to make sure people die on time, before they run too much of a tab.
Good to know that you support the government making those decisions. Let the gov’t make those choices, let the medical community experiment on you, why can’t people just lay down and take whatever the better educated and more powerful dish out to you right? After all, it’s all for the common good and what reasonable person could possibly be against that? Certainly not Tom Perkins.
Citizen, what’s the alternative? I’m not asking to be sarcastic. I agree with you that transparency is lacking in the medical industry, and the idea of the death panels abhors me as much as it does you. Let’s review how we got here:
There’s a whole bunch of people who will soon be relying on government, in some form or another, to pay for their medical care. They never saved anything to pay for their own care (or retirement, but that’s another argument) in part because they bought into the fiction that the pyramid scheme of Medicare could go on forever. The monetary value of the treatment that they expect to get will far, far exceed the amount of money they put in plus the amount of money that the younger generation is capable of putting in now (assuming that we’re willing to rob the future to pay today’s bills, which is terrible in itself, but let’s put that aside for the moment). The gap simply cannot be closed — there is no tax rate the government could levy that would produce enough money, due to the Laffer curve (which IMO we are already on the down side of).
The big-government solution to this, which Obamacare implements, is rationing. Note that it really isn’t doing anything different from what Medicare would soon be forced to do; it’s just doing it a few years earlier. When you have rationing, you have ration boards deciding who gets what. And yes, the popular and politically well-connected get more, just as they did during WWII and the ’70s oil crisis. That’s the way it works. Abhorrent, yes. But consider the alternative: decree an increased supply. You realize what that means: people such as yourself are forced by the government to work without compensation. At gunpoint if necessary. You think your job is tough now, imagine being compelled to do it without being paid, and then having to go take a second job just so you can eat. That’s what happens when the the government tries to veto the iron laws of economics.
So what’t the way out of the trap? I only see one way: increased assumption of risk by the patients. If you have a serious disease, you may be able to break out of the ration and death-panel trap by signing on to take a drug or agree to a procedure that isn’t as well tested or shaken out. Yes, this goes contrary to the way that we’ve thought of medicine for the past century. But, as the original article points out, a lot of medical advances have come about that way, and at least now maybe we’d have more transparency in the process. And anyway, people still die; maybe a few years later, but they still die. All of our risk aversion and malpractice lawsuits haven’t bought us immortality.
Where’d you get the idea I supported government making such decisions? I just said the government can’t repeal the laws of economics, and you thought that mean I approved of them trying?
I think your nurse needs to turn up your oxygen.
Dear Nurse Ratchett; a little bit of knowlege is a dangerous thing. And, unfortunately, an occupational hazzard ampng RNs.
hazard among
And how many times, oh fount of knowledge, have you been on the phone in the middle of the night having a physician reaming out your ass for calling them and reporting critical findings that can impact the patient right now but the physician can’ t be bothered. Pt has to wait until the morning. Why do you think hospitalists are so prevalent in facilities that strive to provide great care. How many times have you rescued a patient who without your intervention would die? How many times have you done CPR? Happen to know why when you are having chest pain you get oxygen, aspirin and morphine as well as specific labs and an EKG? Its called evidence based medicine and a pathway. These things are designed to decrease errors and increase quality care. Where do these things come from? Studies that people volunteer for. Never, never should it be any other way. How ethical and moral is it to withhold critical treatment from a patient who has no idea that is happening?
Nurses are patient advocates, not advocates for the physician or the facility. Don’t want the government making decisions for you? I would think not. In the same manner you should have that same expectation from your physician. Decisions cannot be made without the patient being properly educated. You and others who feel it appropriate to belittle my education and experience will scream bloody murder over the government messing in your healthcare but in your infinite wisdom would roll over and gladly let a physician do the same thing. Not all physicians are good at what they do and some truly don’t give a damn about you.
You want to volunteer sweatheart or volunteer your children go ahead. As for me and mine, we decline.
Well, sweetie, I’ve done all of those things, and more for a very long time. And during tht time what I’ve observed is a dumbing down of the nursing staff. A nursing staff that is indoctrinated with ‘documenting’, i.e. scribbling incessantly while ignoring patients’ needs. Ignoring requests for help. Ignoring the inquiries of families. Watching the clock. A little knowlege is a dangerous thing. If you want to be a patiengt advocat, get a law degree.
Naw, I call BS. Otherwise you would have some kind of clue of the actual role nurses are educated to regarding patient advocacy. As it is you are obviously ignorant of that, as well as ignorant of what nurses actually document and provide to their patients. You simply sound ugly and bitter with very little actual knowledge yet certainly opinionated. No intellectual arguments from you simply name calling and mockery. There is no moral or ethical argument that would make experimenting on people without their knowledge ok. Anyone who argues otherwise is someone with no integrity.
@Mere citizen – No – she’s right. Nurses are dumber than a bag of rocks. The older ones are smart – but the young ones are too stupid to live (i.e. like trying to get blood out of an arm of a habitual blood doner who KNOWS you can’t get any blood out of one arm, but the nurse just thinks they know so much better and you get an arm full of holes that take forever to heal!).
I’m with her. You want to advance medical knowledge, go ahead and volunteer.
Now you are just Stalin…
Why not test on the criminals? Give them time off for their effort and you get a quality test across the section of population. Or just limit the tests to those with life without parole and those with the death sentence. Seems just as moral as what has been suggested so far.
Argon gas has been shown to be the best anesthetic found to date and it was tried on a premature infant that was known to be nonviable without surgery. It worked and today we have the gas and are better for it.
“Now you are just Stalin… ”
Oh come now! You liberals are all alike! You make these illogical “leaps” that connect the oddest things. From research being hamstrung and hogtied with regulations/licensing/fees/etc. you think the “logical” conclusion to that is experimenting on the unwashed masses.
GO AWAY!
Wow are you confused regarding liberals and conservatives. Oh and by the way nurses don’ t generally draw blood. Lab techs do or in the office med ass’ t do. It costs too much money to employ nurses to do such simple tasks. I draw from a patient when the rach can’t. The fact that you may physically difficult to draw does not mean people who have to poke you more than once are dumb either. They are trying to help you, what a shame you can’t appreciate the difficulties they are working with in order to take care of you and your needs.
She’s right, Lolly, nurses usually do not draw blood. Their primary activity is scribbling which leaves precious little time for anything useful. Sceribble, scribble, scribble.
Dr. Daniels point is minor. The great drag upon innovation and improvement in medicine is the bureaucratic mind of government. There is no question that a drug or a procedure which has adverse consequences for ten persons and beneficial effects for 100 will not be approved. Patients and doctors cannot be permitted to judge their own fates, only bureaucrats can. Worse, this has an effect upon research and development. That is why we learn of what is state-of-the-art through clinics set up third world places like the Dominican Republic, free from the reach of the nanny state.
We need a group of second-class citizens who are already condemned to lives of harrassment and contempt because of crimes that they have committed, either themselves or by their ancestors, to experiment with. That way if they die or are maimed, humanity will still be served.
Fortunately, we have a class like that…white males. And for the really risky and dangerous drugs, successful white males.
The answer to this is: There is no money in curing anything, keep ‘em coming back for billing.
When was the last time you heard of a cure for anything? Despite massive amounts of money begged, borrowed or stolen “for the cure”. I’d bet far more of that goes to executive perks and salaries than to finding a cure.
Spot; on. LED—-the Obama paradign…LET EM DIE. Sorry seniors.
Yeah! I’m sick of the medical cocktails they give to people so they can “live” with whatever they have. I think they must be kicking themselves all over for that polio cure when a symptom cocktail could have had people coming back forever.
You ALWAYS have the option to decline treatment. There is no fairy dust.
There is an interesting discussion of this coming out of a recent book, “The Immortal Life of Henrietta Lacks”. While the actual situation in the book seems (or is) benign, the author mentions another case where a patient was taken advantage of for his own profit. Worth reading; I assume people here can account for the author’s bias.
This is one reason wars advance medicine; in war you have to try risky stuff.
But there is no excuse for using a patient as an experiment against his will; if you want to advance medicine, go ahead and volunteer. The ends do not justify the means.
I suggest we keep the “safe” rules, and cut back on the “effective” requirements.
Medical ethics is an entirely contrived “specialty”…as is most ethics. Those passing judgment as to ethical observance carry their own baggage to the forum. That said, it is an interesting concept that we strive for perfect standards on medication enforced by the FDA and tort bar while at the same time dumbing down the practice of medicine by granting expanded independent responsibility to half trained extenders while at the same time limiting the actual training of our specialists with work rules and mandatory nonsense courses.
When the FDA is moving to regulate iPad and tablet apps, and will not allow diagnostic databases that are more accurate than most doctors, then there is something seriously wrong.
A solution is obvious: the registration of all trials and the compulsory publication of their results, favorable or unfavorable.
you mean like clinicaltrials.gov?
I think we need an internet police to keep this garbage out of the ‘net
Well, munchkin, having practiced medicine for a number of years, having been witness to the deterioration in general nursing standards, I guess I’m entitled to be opinionated. But hey, who should I believe, you or my lying eyes. The one constant that I have observed among the nursing staff is the general deficiency of common sense, as in the infamous 3 AM call to the doctor to approve a laxitive, and the slavish reliance on ‘guidlines’ and pathways. And the scribbling.
If you actually are a physician I will bet you dollars to donuts that there has been more than once you hinny was saved by one of those dumb nurses. Since nurses aren’t bright enough to decide if its ok to give a screaming bowel obsessed patient an over the counter laxative in middle of the night, after all thats your argument yes? Then you should be bright enough to anticipate your patient needs and order it to start with. Of course since you are such a condescending so and so regarding nurses and obviously have little actual clue what we do in a 12 hour shift or the uh, legal reasons we do all that goofy scribbling, it likely doesn’t occur to you if you did your freaking job you wouldn’t get those kind of calls, far easier to rely on the nurses to do it for you and then bitch about it.
Apparently you are just having difficulty with not being the all knowing authority over patients and nurses medicine once had. So sorry, time to get with the times. After 21 years its great to see the progress nursing has made from having to give up chairs to the holy docs and fetch their coffee. Sorry you fibf that offensive.
Hmmm, Sweepea, you sound a bit ugly and bitter, and, um, opinionated. I must admit that your intellectual arguements are dazzling. You seem to have a thin skin and a large ego. I am sure, though, that your hand writing is immaculate, what with all of that scribbling. Perhaps it’s time for your midnight laxitive, considering the rising tide of BS I’m hearing.
Tom Perkins I can’t answer you above so I am here.
Allow me to quote the beginning of this article. “It is doubtful whether, if current ethical standards, such as those governing informed consent, had existed in the past, medicine would have made much progress.”
Then the discussion regarding the dilemma the FDA ruling has created.
Now let me quote the end. “But a still small voice at the back of my mind asks, If this had been the policy in the 1840s, should we now have anaesthetics? Afterall, people soon began to die of ether and choroform.”
If that is not wistful thinking of the good ole days when informed consent was not part of medicine, than the author has made a good show of it.
When I asked by what right would a physician or pharmacy have to make those choices this was your response to me.
“They ARE COMMANDED( my emphasis) to do so by the iron laws of economics. We have long since past the point where we needed the option legally to take a higher risk at a lower cost.”
So we are long past needing a legal or perhaps even ethical reason to do whatever we want to peoples bodies and thus ultimately their life. It is instead all about economics. If thats the only true consideration coupled with that longing for the days of no consent we could just go ahead manipulate whatever we wanted in the name of the common good and of course because everyone in medicine is really just altruistic.
You also made it clear you consider my education wasteful and a nurses place in society completely unjustified as is the licensing of nurses. After all what do nurses really need to do is follow orders. In this day and age that type of thought process is nearly incomprehensible given the complexities of care. It bespeaks willful ignorance. And frankly I didn’ t need a specialized education to be able to know right from wrong. Or how to treat people when they are at their most vulnerable. All that takes is a decent upbringing.
None of that explains why you think my stating the government cannot repeal the laws of economics, is my endorsing either Obamacare or physicians making healthcare choices for their patients without so much as a by-your-leave.
Try reading this again:
http://pjmedia.com/lifestyle/2012/10/06/do-todays-medical-ethics-prevent-new-breakthroughs/#comment-281430
Also, you seem to object to reality, when you wrote:
“Why yes, lets allow “the iron laws of economics” dictate your health care. With that type of thinking from so called conservatives we might as well ready the death panels ’cause the coming onslaught of demographics is going to dictate the need to control costs. Just the iron law of economics, don’ t you know.”
Whether Obamacare is a stalking horse for them or the market is, which unlike government is complete with charity, the laws of economics are unrepealable. They are always in effect. What you wrote could be interpreted as your imagining the laws of economics might not dictate your healthcare. They will.
This sentence: ““They ARE COMMANDED( my emphasis) to do so by the iron laws of economics. We have long since past the point where we needed the option legally to take a higher risk at a lower cost.””
In fact says nothing about approving of physicians making dire healthcare choices for their patients, either by government fiat or their own experimental initiative. It is explicitly and solely a recognition that medicine should be de-regulated and government disintermediated from it.
drug- testing subjects tend to be in amazing physical health. the populations you would want to test these drugs are not in as good health. It’s hard to sort out the effects of the drugs if the person is already ill.
Seriously, these are the most amazing physical specimens you have ever seen in one place, outside of a track meet. Height/ weight proportionate, great blood pressure, no diseases. Symmetrical, usually.
So, purely healthy to get close to blank-slate-ness. Most drugs that make it this far are very effective. It’s sorting out what the effects are, and how they can be marketed.
I wouldn’t want prisoners drug-testing. Poor health, odd diseases, private drug habits, poor food choices, bad epigenetics. The drugs would get blamed for lifestyle choices.