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mkemse
10-23-2008, 07:45 PM
LONDON – About half of American doctors in a new survey say they regularly give patients placebo treatments — usually drugs or vitamins that won't really help their condition. And many of these doctors are not honest with their patients about what they are doing, the survey found.

That contradicts advice from the American Medical Association, which recommends doctors use treatments with the full knowledge of their patients.

"It's a disturbing finding," said Franklin G. Miller, director of the research ethics program at the U.S. National Institutes Health and one of the study authors. "There is an element of deception here which is contrary to the principle of informed consent."

The study was being published online in Friday's issue of BMJ, formerly the British Medical Journal.

Placebos as defined in the survey went beyond the typical sugar pill commonly used in medical studies. A placebo was any treatment that wouldn't necessarily help the patient.

Scientists have long known of the "placebo effect," in which patients given a fake or ineffective treatment often improve anyway, simply because they expected to get better.

"Doctors may be under a lot of pressure to help their patients, but this is not an acceptable shortcut," said Irving Kirsch, a professor of psychology at the University of Hull in Britain who has studied the use of placebos.

Researchers at the NIH sent surveys to a random sample of 1,200 internists and rheumatologists — doctors who treat arthritis and other joint problems. They received 679 responses. Of those doctors, 62 percent believed that using a placebo treatment was ethically acceptable.

Half the doctors reported using placebos several times a month, nearly 70 percent of those described the treatment to their patients as "a potentially beneficial medicine not typically used for your condition." Only 5 percent of doctors explicitly called it a placebo treatment.

Most doctors used actual medicines as a placebo treatment: 41 percent used painkillers, 38 percent used vitamins, 13 percent used antibiotics, 13 percent used sedatives, 3 percent used saline injections, and 2 percent used sugar pills.

In the survey, doctors were asked if they would recommend a sugar pill for patients with chronic pain if it had been shown to be more effective than no treatment. Nearly 60 percent said they would.

Smaller studies done elsewhere, including Britain, Denmark and Sweden, have found similar results.

Jon Tilburt, the lead author of the U.S. study, who is with NIH's bioethics department, said he believes the doctors surveyed were representative of internists and rheumatologists across the U.S. No statistical work was done to establish whether the survey results would apply to other medical specialists, such as pediatricians or surgeons.

The research was paid for by NIH's bioethics department and the National Center for Complementary and Alternative Medicine.

The authors said most doctors probably reasoned that doing something was better than doing nothing.

In some cases, placebos were given to patients with conditions such as chronic fatigue syndrome. Doctors also gave antibiotics to patients with viral bronchitis, knowing full well that a virus is impervious to antibiotics, which fight bacteria. Experts believe overuse of antibiotics promotes the development of drug-resistant strains of bacteria.

Some doctors believe placebos are a good treatment in certain situations, as long as patients are told what they are being given. Dr. Walter Brown, a professor of psychiatry at Brown and Tufts universities, said people with insomnia, depression or high blood pressure often respond well to placebo treatments.

"You could tell those patients that this is something that doesn't have any medicine in it but has been shown to work in people with your condition," he suggested.

However, experts don't know if the placebo effect would be undermined if patients were explicitly told they were getting a dummy pill.

Brown said that while he hasn't prescribed sugar pills, he has given people with anxiety problems pills that had extremely low doses of medication. "The dose was so low that whatever effect the patients were getting was probably a placebo effect," he said.

Kirsch, the psychologist, said it might be possible to get the psychological impact without using a fake pill. "If doctors just spent more time with their patients so they felt more reassured, that might help," he said.

Some patients who had just seen their doctors at a clinic in London said the truth was paramount.

"I would feel very cheated if I was given a placebo," said Ruth Schachter, an 86-year-old Londoner with skin cancer. "I like to have my eyes wide open, even if it's bad news," she said. "If I'm given something without being warned what it is, I certainly would not trust the doctor again."

Anyone suprised by this survey?? Keep in mind it was done in London and not here in the USA

lucy
10-24-2008, 12:45 AM
And many of these doctors are not honest with their patients about what they are doing, the survey found.
Well, if a doctor tells the patient it's a placebo, it isn't a placebo anymore, isn't it?
And placebos in fact can help, whereas telling a patient "sorry, but i can't help you with your problem" which would often be the right and honest thing to do would also just make the patient move on to the next doc.

However, i think using actual drugs like painkillers and especially antibiotics is definitely wrong.

fetishdj
10-24-2008, 04:09 AM
A placebo will indeed not work if the patient knows it is a placebo... this has been shown time and again in trials. So the initial accusation is indeed a little off.

I do agree that spending more time with patients may be better than placebos, however... though I cannot see it happening anytime soon with the level of work most GPs have to deal with normally...

mkemse
10-24-2008, 06:01 AM
Well, if a doctor tells the patient it's a placebo, it isn't a placebo anymore, isn't it?
And placebos in fact can help, whereas telling a patient "sorry, but i can't help you with your problem" which would often be the right and honest thing to do would also just make the patient move on to the next doc.

However, i think using actual drugs like painkillers and especially antibiotics is definitely wrong.

If I am in extreme pain do to chronic back problem, a very bad cold ect, I would not want a Placebo ,I want the real thing, yes there are cases where a Placebo may trick the mind to believe it feels better, but in the Case of Servere Chronic Back Pain, the Flu ect I want the real thing not a Sugar Pill
But then again I have had the same Internest for 30 years so there is no question in my mind whether I trust or believe in him:wave:

Flaming_Redhead
10-24-2008, 08:28 AM
I'll start out by saying I've worked in hospitals for many years, although I'm not a doctor or nurse. People these days go to doctors requesting pills. They see commercials on TV and run to their doctor to try it. My ex-mother-in-law was somewhat of a hypochondriac and was always wanting the doctor to do something for her bursitis and arthritis, both chronic problems. He told her that she would just have to live with it. She didn't want to hear that, but neither did she want to do what he told her to do. She didn't want physical therapy or exercise or weight loss. She wanted pills, but she never liked what he gave her, either narcotics or anti-inflammatories. She wouldn't take narcotics because of her fear of becoming addicted, and she wouldn't take the anti-inflammatories because she said it was like taking Tylenol. Her internist believed that most of her complaints were anxiety-related, so the doctor tried repeatedly to place her on different meds for it. As soon as she discovered what it was for (anxiety/depression), she discontinued it, saying that she didn't have anxiety or depression. I very much believe she DID. *nods a lot* The problem with people is that they don't want to be proactive in their health or hear the truth. They want a magic pill. I don't blame the doctors for giving it to them. It's been proven that positive thinking helps chronic conditions, so if they think they're getting something to help them and want to believe that it works....it will.

fetishdj
10-25-2008, 07:08 AM
High levels of cortisol can cause problems with healing injuries/tissue damage/reducing infection or preventing cancer. Cortisol is a stress hormone. You do not get high levels of Cortisol if you are happy and relaxed... so there is clearly a benefit here from the placebo effect and it is more than 'mind over matter'. Whether the pill itself does anything is irrelevent - the effect is entirely mediated from within.

mkemse
10-25-2008, 07:43 AM
I would trust my Docotor that i have had for 30 years in subscribing me medication and not a placebo but doctors should be honest with their patients annd telel then what they are recieinving and not just simply give them a placebo

MMI
11-02-2008, 07:38 AM
The whole idea of giving a placebo is to trick the patient. If you tell him/her, as lucy points out, it ain't gonna trick anyone.

I suspect the doctors are only going to use a placebo where there's no available (or affordable) medicine that will work and the patient is awkward or insistent, such as Redhead's ex mother-in-law, or just to make the patient think that something is being done, even though it isn't - and maybe can't be (... is that the same thing?).

Anyway, I don't see it as harmful, and it's only deceitful in the same way as saying to a patient suffering from a terminal disease, We're doing everything we can to make you better ...

SadisticNature
02-13-2010, 07:28 PM
It can be very harmful if:

Doctor A doesn't have a real solution so gives a placebo and the patient would have otherwise gone to Doctor B who knows of a different solution that would actually work for that patients problems.

Also prescribing placebos will look pretty horrible in a court case if the doctor ever gets sued, and if 60% of them are doing it its not a surprise the malpractice insurance is expensive.

DuncanONeil
02-13-2010, 10:57 PM
Why does SadisticNature always look for the lead lining?

denuseri
02-13-2010, 11:58 PM
Maby becuase its ussually there and needs to be discussed as well Duncan.

Placebos also bring to mind the studies involved with noetic sciences in these avenues.

DuncanONeil
02-14-2010, 12:29 PM
Maby becuase its ussually there and needs to be discussed as well Duncan.

Placebos also bring to mind the studies involved with noetic sciences in these avenues.

I don't know; "Doctor A doesn't have a real solution so gives a placebo", seems like more than covering all the bases.

SadisticNature
02-14-2010, 01:36 PM
So its acceptable for doctors to trick patients into paying for something that's only value to them is psychological?

Lets try that in the finances, would you agree with the following statement?

"It's ok for a financial banker to trick someone about how safe their investments are as long as they believe the person will make money?"

To me these situations seem comparable, you're deliberately tricking someone, and justify it by believing you are doing it for their own good. You might be right (and lots of data shows placebo's can help), but you might be wrong as well (you might prevent them from pursuing a better course of treatment).

If someone actually wanted a placebo let them sign up for a research study, they'll either get a placebo or something that potentially works and is safe enough for testing on humans.

Bren122
02-14-2010, 03:17 PM
While I accept that some people suffer from migraines I do not believe it is as prevalent as it seems. I think that too many people confuse a bad headache with a migraine. I just tell people I don't believe in the condition; as a consequence the sickness rates in my department are about a quarter of that for the organisations I have worked for as a whole.
Similarly everyone used to have RSI and then that died down and was replaced with Chronic Fatigue Syndrome and then that died down and has been replaced with Depression. I personally think that they have all been overstated and, realistically, in twenty years of working I can only think of two people who had genuine RSI and one person with genuine depression. The rest were either trying to avoid work or were overstating their condition in order to get attention. I can just imagine how much worse it must be for a doctor who would see it on an hourly basis. People are convinced that if there is something wrong with them that it is the most serious thing possible and that they need to be booked into intensive care immediately. I imagine that most of these doctors prescribing placebos are doing so in order to get these people out of their clinics so that they can help people with real problems.

fetishdj
02-15-2010, 03:17 AM
There is no such thing as a 'mugraine', like 'IBS' it is a term which means 'collection of conditions with unknown cause which has a set of similar and overlapping symptoms'. If you look at the symptoms and causes of many 'migraines' you in fact see different causes (some are caused by bright light, some by loud noise, some by different food allergies, some by stress) and a vague set of symptoms which vary a lot between patients. This is why some migraine sufferers respond to 'migraleive' and similar drugs while others do not - they are actually different conditions.

There are many conditons which doctors cannot treat, and I am not talking here about the biggies like cancer or AIDs (which we are getting better at treating, its just that often the treatment is worse than the disease). Mainly this is because we do not understand the underlying mechanism of that disease because the medical profession is reliant on the rather subjective and uninformative process of patient self reporting of symptoms ('What seems to be the problem?' 'I have a headache and stomach ache' 'How bad is the stomach ache?'...). Doctors have got very good at teasing out truth and lies and relevant information from the rather vague information that patients tell them but it is still not a great tool. Sometimes you get a patient with no actual serious symptoms - possibly some minor stress related problems that are clearly not linked to any underlying problem which can be treated more directly. In this case, the best thing you can do is alleviate the stress (and giving a placebo will achieve this) in the hope that this solves the problem. If it doesn't, you can look at more direct intervention.

The old adage is true - medicine really is the process of amusing the patient while the body treats itself.

DuncanONeil
02-15-2010, 01:26 PM
Economics and medicine can in no way provide an adequate comparison.
Much of medicine is in the mind even when a drug is prescribed. The complaint against your offer was that there may be nothing wrong with the patient, yet they insist that there is and some drug will help them. With no evidence of an underlying malady you are opposed to the doctor prescribing a placebo. Or in the case where the patients desire for a specific advertised drug is also not indicated for their "condition" the doctor can not exercise his training and "treat" HIS patient in the manner that best suits HIS patient.
Part of the problem is again the assumption that if the patient is at the doctor that there must absolutely be something wrong!


So its acceptable for doctors to trick patients into paying for something that's only value to them is psychological?

Lets try that in the finances, would you agree with the following statement?

"It's ok for a financial banker to trick someone about how safe their investments are as long as they believe the person will make money?"

To me these situations seem comparable, you're deliberately tricking someone, and justify it by believing you are doing it for their own good. You might be right (and lots of data shows placebo's can help), but you might be wrong as well (you might prevent them from pursuing a better course of treatment).

If someone actually wanted a placebo let them sign up for a research study, they'll either get a placebo or something that potentially works and is safe enough for testing on humans.

DuncanONeil
02-15-2010, 01:29 PM
Sounds a bit like my perception of "stress". Something I refuse to accept as a "condition".


While I accept that some people suffer from migraines I do not believe it is as prevalent as it seems. I think that too many people confuse a bad headache with a migraine. I just tell people I don't believe in the condition; as a consequence the sickness rates in my department are about a quarter of that for the organisations I have worked for as a whole.
Similarly everyone used to have RSI and then that died down and was replaced with Chronic Fatigue Syndrome and then that died down and has been replaced with Depression. I personally think that they have all been overstated and, realistically, in twenty years of working I can only think of two people who had genuine RSI and one person with genuine depression. The rest were either trying to avoid work or were overstating their condition in order to get attention. I can just imagine how much worse it must be for a doctor who would see it on an hourly basis. People are convinced that if there is something wrong with them that it is the most serious thing possible and that they need to be booked into intensive care immediately. I imagine that most of these doctors prescribing placebos are doing so in order to get these people out of their clinics so that they can help people with real problems.

SadisticNature
02-15-2010, 07:44 PM
Economics and medicine can in no way provide an adequate comparison.
Much of medicine is in the mind even when a drug is prescribed. The complaint against your offer was that there may be nothing wrong with the patient, yet they insist that there is and some drug will help them. With no evidence of an underlying malady you are opposed to the doctor prescribing a placebo. Or in the case where the patients desire for a specific advertised drug is also not indicated for their "condition" the doctor can not exercise his training and "treat" HIS patient in the manner that best suits HIS patient.
Part of the problem is again the assumption that if the patient is at the doctor that there must absolutely be something wrong!

Patients are not the property of doctors. If nothing is wrong the doctor is allowed to within the confines of the law refuse to provide unnecessary treatments. Giving someone a placebo to shut them up is highly problematic. Particularly, because sometimes the doctors are actually wrong, and if they do the consequences are very serious.

There is a reason why prescribing placebo's is illegal, and that reason is a good one. Even assuming most patients are hypochondriacs or looking to score some painkillers, refusing treatment is a viable option, and its one that doesn't hinder the people who actually suffer from legitimate conditions. Often unexplained pain is an early warning sign for certain forms of cancer, and if a doctor treats it with a placebo resulting in a delayed diagnosis that's almost certain to be a massive lawsuit, and I wouldn't for a second think the patient was in the wrong.

DuncanONeil
02-17-2010, 09:19 AM
There is no solid evidence that the prescription of placebos is illegal. In reviewing the AMA position it is clear that the use of placebos is allowed. Were such use illegal the AMA could not be allowing it, as such would be condoning an illegal act.
Also you continue to assume that the doctor has no understanding of the patient they are seeing nor any understanding of how they can be helped.
Comparing people to cars is insulting, cars can not think or feel!


Patients are not the property of doctors. If nothing is wrong the doctor is allowed to within the confines of the law refuse to provide unnecessary treatments. Giving someone a placebo to shut them up is highly problematic. Particularly, because sometimes the doctors are actually wrong, and if they do the consequences are very serious.

There is a reason why prescribing placebo's is illegal, and that reason is a good one. Even assuming most patients are hypochondriacs or looking to score some painkillers, refusing treatment is a viable option, and its one that doesn't hinder the people who actually suffer from legitimate conditions. Often unexplained pain is an early warning sign for certain forms of cancer, and if a doctor treats it with a placebo resulting in a delayed diagnosis that's almost certain to be a massive lawsuit, and I wouldn't for a second think the patient was in the wrong.

denuseri
02-17-2010, 11:45 AM
Duncan you should hear doctors,,surgeons in paticular (especially ortho docs and nurses) talk about patients some time when they think the patient can't hear.

Often refering to themselves as mechanics.

Interpersonal relations and politically correct bs aside.

Paitients are often spoken of in very inpersonal manners, I know a dozen nurses who can't remember their paitents names from day to day, but can put whats wrong with them to the room numbers where they are. The tv version of the weepy nurse or doctor is a far cry from the reality sometimes. Its not that we dont feel sorry for them, or hold their hand and cry mabey even (time permitting) , but if you let that rule you, you will burn out real quick and wont be able to do your job.

Bren122
02-17-2010, 01:00 PM
There's a scene in Scrubs where a doctor has to tell a family his patient died; one of the characters makes the point that there is only one person in that room who is going back to work that day and he needs to do what it takes to get him over the loss of a patient and concentrate on the next one. Really made me stop and think what a shitty job most doctors and nurses have.

DuncanONeil
02-21-2010, 08:50 AM
I still think my comment; "Also you continue to assume that the doctor has no understanding of the patient they are seeing nor any understanding of how they can be helped.
Comparing people to cars is insulting, cars can not think or feel!", stands.

I did use the term understand not compassion. The car comment was directed at something Sadistic said. But your rebuttal does not seem to have the medicos referring to patients in the manner they "refer" to themselves. As for remembering, we all give differing portions of the data we are assailed with different priorities. I know I do! Things that are in a given place, readily available to me, does not require me to have those items in priority memory files.
Further I agree that being a member of the Grey school of medicine vs the Yang school can use you up very fast! But the thing we want doctors to do most of all is "fix" us. Why? Because there is something "wrong". After that I expect them to talk to me not at me.


Duncan you should hear doctors,,surgeons in paticular (especially ortho docs and nurses) talk about patients some time when they think the patient can't hear.

Often refering to themselves as mechanics.

Interpersonal relations and politically correct bs aside.

Paitients are often spoken of in very inpersonal manners, I know a dozen nurses who can't remember their paitents names from day to day, but can put whats wrong with them to the room numbers where they are. The tv version of the weepy nurse or doctor is a far cry from the reality sometimes. Its not that we dont feel sorry for them, or hold their hand and cry mabey even (time permitting) , but if you let that rule you, you will burn out real quick and wont be able to do your job.

SadisticNature
02-22-2010, 04:52 PM
I still think my comment; "Also you continue to assume that the doctor has no understanding of the patient they are seeing nor any understanding of how they can be helped.
Comparing people to cars is insulting, cars can not think or feel!", stands.

I did use the term understand not compassion. The car comment was directed at something Sadistic said. But your rebuttal does not seem to have the medicos referring to patients in the manner they "refer" to themselves. As for remembering, we all give differing portions of the data we are assailed with different priorities. I know I do! Things that are in a given place, readily available to me, does not require me to have those items in priority memory files.
Further I agree that being a member of the Grey school of medicine vs the Yang school can use you up very fast! But the thing we want doctors to do most of all is "fix" us. Why? Because there is something "wrong". After that I expect them to talk to me not at me.

I still find the idea that you think doctors should be able to give placebo's to patients is grossly inconsistent with your stated desire to lower malpractice claims.

I'm not saying doctors are going to be wrong often with placebo's but I think even if they are wrong 1 time in 1000 patients that is going to be a large number of lawsuits. I think the claim that doctors aren't perfect is rather reasonable and backed up by the data.

Even if 999 out of 1000 patients that are given placebo's do better than those who are not, the doctors have no business giving out placebo's because when they are wrong its going to be a serious mistake.

What kind of damages do you think an insurance company will have to pay when the following situation occurs:

(i) Doctor diagnoses patient as a hypochondriac
(ii) Doctor proscribes placebo
(iii) Patient thinks placebo is working and doesn't see a doctor again until their next regular checkup.
(iv) Patients symptoms were actually related to cancer which is discovered at this checkup roughly a year later.
(v) Patient eventually dies as a result of the cancer.

In situations like this the damages can be colossal because for many cancers survival rates are very good for early diagnosis, while for later diagnosis survival rates are far worse. Cases like these are easy to win and easier to get a big settlement on, because the doctor is involved in deceiving the patient which results in them not seeking other treatments or care.

Thorne
02-22-2010, 07:47 PM
(i) Doctor diagnoses patient as a hypochondriac
(ii) Doctor proscribes placebo
(iii) Patient thinks placebo is working and doesn't see a doctor again until their next regular checkup.
(iv) Patients symptoms were actually related to cancer which is discovered at this checkup roughly a year later.
(v) Patient eventually dies as a result of the cancer.

One problem I have here, though. If the patient's symptoms are relieved by the placebo, then their is not problem. If it's cancer, or some other serious disease, the placebo would not work. He might feel some relief for a brief time, perhaps, but as the disease progresses the placebo effect falls off. Chances are the doctor would not let him go for a year anyway, but have him check back in a week or two. If at that time the symptoms are relieved THEN he might diagnose hypochondria, not before.

And I doubt that any reputable doctor would go right to placebos anyway. He'd have to have some kind of indication from the patient's history before taking that step.

DuncanONeil
02-23-2010, 09:52 AM
In this age of defensive medicine, where doctors run every possible test for every possibility, the likelihood of a misdiagnosis is small. When all science says there is nothing wrong and the patient essentially demands medication what is a doctor to do? Follow the science, do nothing, allowing the patient to seek a doctor that may have less ethics and prescribes an actual medication from which the patient dies of a side effect?
In the realm of malpractice "claims", many of them have nothing to do with the practice of medicine. The data reflects that most are without merit and have the appearance of an attempt to engineer a lottery win. Most of which goed to the legal community!


I still find the idea that you think doctors should be able to give placebo's to patients is grossly inconsistent with your stated desire to lower malpractice claims.

I'm not saying doctors are going to be wrong often with placebo's but I think even if they are wrong 1 time in 1000 patients that is going to be a large number of lawsuits. I think the claim that doctors aren't perfect is rather reasonable and backed up by the data.

Even if 999 out of 1000 patients that are given placebo's do better than those who are not, the doctors have no business giving out placebo's because when they are wrong its going to be a serious mistake.

What kind of damages do you think an insurance company will have to pay when the following situation occurs:

(i) Doctor diagnoses patient as a hypochondriac
(ii) Doctor proscribes placebo
(iii) Patient thinks placebo is working and doesn't see a doctor again until their next regular checkup.
(iv) Patients symptoms were actually related to cancer which is discovered at this checkup roughly a year later.
(v) Patient eventually dies as a result of the cancer.

In situations like this the damages can be colossal because for many cancers survival rates are very good for early diagnosis, while for later diagnosis survival rates are far worse. Cases like these are easy to win and easier to get a big settlement on, because the doctor is involved in deceiving the patient which results in them not seeking other treatments or care.

DuncanONeil
02-23-2010, 09:55 AM
One problem I have here, though. If the patient's symptoms are relieved by the placebo, then their is not problem. If it's cancer, or some other serious disease, the placebo would not work. He might feel some relief for a brief time, perhaps, but as the disease progresses the placebo effect falls off. Chances are the doctor would not let him go for a year anyway, but have him check back in a week or two. If at that time the symptoms are relieved THEN he might diagnose hypochondria, not before.

And I doubt that any reputable doctor would go right to placebos anyway. He'd have to have some kind of indication from the patient's history before taking that step.

Agreed! I thought to, but did not mention the return visit. I have yet to visit a doctor for a medical complaint that has not included a return within a short period of time!

SadisticNature
02-23-2010, 02:31 PM
Agreed! I thought to, but did not mention the return visit. I have yet to visit a doctor for a medical complaint that has not included a return within a short period of time!

People are very good at convincing themselves their treatments are working. So much so even the survival rates can go up from placebo's. Patients are both less likely to experience symptoms and less likely to complain about them when they think they are already doing something about it. This is the reason medicine tests use double blind trials.

SadisticNature
02-23-2010, 02:41 PM
I think this falls into the realm of opinion. I certainly feel its a hassle to get doctors to run tests they ought to rather than the other way around.

The doctor isn't responsible for what other doctors choose to do. The consequences of actions are not justified by "oh someone else would have done it anyways, but worse".

As for your opinion that the data reflects most claims are without merit and have the appearance of an attempt to engineer a lottery win, I certainly feel this is not the case from the actual examples you gave. Waking up cut open on a table is certainly a valid complaint and is a situation that can do serious psychological harm.

The numbers can be interpreted in many ways. It could be that 90% of the cases that go to court are being lost because the standard of proof is incredibly high to patient disclaimers, and that proving negligence can be difficult. It could also be that 90% of the cases that go to court are lost because there are too many opportunists who file flimsy cases. This doesn't say most of the cases are flimsy though, maybe the medical insurance companies are smart enough to settle the good cases and only push on the bad ones.

It is incorrect to say there is no opportunism in this area, but its also incorrect to say that because there is some opportunism there are no legitimate cases.


In this age of defensive medicine, where doctors run every possible test for every possibility, the likelihood of a misdiagnosis is small. When all science says there is nothing wrong and the patient essentially demands medication what is a doctor to do? Follow the science, do nothing, allowing the patient to seek a doctor that may have less ethics and prescribes an actual medication from which the patient dies of a side effect?
In the realm of malpractice "claims", many of them have nothing to do with the practice of medicine. The data reflects that most are without merit and have the appearance of an attempt to engineer a lottery win. Most of which goed to the legal community!

Thorne
02-23-2010, 07:09 PM
People are very good at convincing themselves their treatments are working. So much so even the survival rates can go up from placebo's. Patients are both less likely to experience symptoms and less likely to complain about them when they think they are already doing something about it. This is the reason medicine tests use double blind trials.

That's all true, which is why a reputable physician wouldn't prescribe a placebo until he'd exhausted all other possibilities. But in the end, if you have a patient with inconsistent symptoms who has no testable problems, you might prescribe a placebo. Let's face it: the patient's reaction to the placebo can be as informative as any other tests the doctor may have done.

The key point, though, is that the placebo is not prescribed lightly but only after a thorough familiarization with the patient. And this may (possibly, should) include a psychiatric analysis.

DuncanONeil
02-26-2010, 09:27 AM
People are very good at convincing themselves their treatments are working. So much so even the survival rates can go up from placebo's. Patients are both less likely to experience symptoms and less likely to complain about them when they think they are already doing something about it. This is the reason medicine tests use double blind trials.

Did you know that they are required to perform said trails three separate times?

DuncanONeil
02-26-2010, 09:53 AM
You want to say; "It could also be that 90% of the cases that go to court are lost because there are too many opportunists who file flimsy cases." After having said; "People are very good at convincing themselves".

The example (note the singular) that was presented does not rise to any level of error on the doctors' part. The patient feels no pain, does not see the incision area. To file a lawsuit against the doctors has no merit. Waking up in a room you have already seen when you expect to wake up in a recovery room does not give the patient the right to take large sums of money from the doctor. By your logic I should have sued the obstetrician that cared for the birth of my daughter because of the ring she wore while examining my wife dilation!

Evidence requirements in cases of this nature only requires a preponderance of evidence. This relatively easy to meet.
Also do not forget that the 90% of cases that fail in court only 4% of cases filed are successful. Does not mean they actually had merit, although I am sure some do. Level of merit aside, level of plaintive success aside the total number of claims all has a cost attached. If the incentive of a extremely large payday is controlled the flimsy, meritless cases will begin to die off. This has a direct effect on costs from reduction in monies going to non-medical effort. And a future effect in the reduction of multiple testing, repetitive testing, testing just in case. All of which has an effect on costs.
And no cost is not all I am thinking about. Yet as a nation we all are concerned about the cost of medical treatment.

Seems as though a large part of your arguments are based in a series of what ifs. That is serial assumptions. You are willing to entertain that opportunists are working the system yet assert that it is minimal.
But the most egregious statement is; "its also incorrect to say that because there is some opportunism there are no legitimate cases". Such a claim is not supported by any statements made nor by logic. No one has ever claimed that legitimate cases of malpractice occur, and admitting that opportunistic cases exist does not deny legitimate ones.


I think this falls into the realm of opinion. I certainly feel its a hassle to get doctors to run tests they ought to rather than the other way around.

The doctor isn't responsible for what other doctors choose to do. The consequences of actions are not justified by "oh someone else would have done it anyways, but worse".

As for your opinion that the data reflects most claims are without merit and have the appearance of an attempt to engineer a lottery win, I certainly feel this is not the case from the actual examples you gave. Waking up cut open on a table is certainly a valid complaint and is a situation that can do serious psychological harm.

The numbers can be interpreted in many ways. It could be that 90% of the cases that go to court are being lost because the standard of proof is incredibly high to patient disclaimers, and that proving negligence can be difficult. It could also be that 90% of the cases that go to court are lost because there are too many opportunists who file flimsy cases. This doesn't say most of the cases are flimsy though, maybe the medical insurance companies are smart enough to settle the good cases and only push on the bad ones.

It is incorrect to say there is no opportunism in this area, but its also incorrect to say that because there is some opportunism there are no legitimate cases.

SadisticNature
02-27-2010, 12:22 PM
You want to say; "It could also be that 90% of the cases that go to court are lost because there are too many opportunists who file flimsy cases." After having said; "People are very good at convincing themselves".

The example (note the singular) that was presented does not rise to any level of error on the doctors' part. The patient feels no pain, does not see the incision area. To file a lawsuit against the doctors has no merit. Waking up in a room you have already seen when you expect to wake up in a recovery room does not give the patient the right to take large sums of money from the doctor. By your logic I should have sued the obstetrician that cared for the birth of my daughter because of the ring she wore while examining my wife dilation!

Evidence requirements in cases of this nature only requires a preponderance of evidence. This relatively easy to meet.
Also do not forget that the 90% of cases that fail in court only 4% of cases filed are successful. Does not mean they actually had merit, although I am sure some do. Level of merit aside, level of plaintive success aside the total number of claims all has a cost attached. If the incentive of a extremely large payday is controlled the flimsy, meritless cases will begin to die off. This has a direct effect on costs from reduction in monies going to non-medical effort. And a future effect in the reduction of multiple testing, repetitive testing, testing just in case. All of which has an effect on costs.
And no cost is not all I am thinking about. Yet as a nation we all are concerned about the cost of medical treatment.

Seems as though a large part of your arguments are based in a series of what ifs. That is serial assumptions. You are willing to entertain that opportunists are working the system yet assert that it is minimal.
But the most egregious statement is; "its also incorrect to say that because there is some opportunism there are no legitimate cases". Such a claim is not supported by any statements made nor by logic. No one has ever claimed that legitimate cases of malpractice occur, and admitting that opportunistic cases exist does not deny legitimate ones.

Either merit is determined by the legal system or it isn't. If it isn't, then claiming the 90% of cases that were dismissed have no merit is wrong (some might involve missed filing deadlines or off on a technicality decision). If it is then you have no basis for claiming the 4% of successful cases lack merit.

You have basically taken a list of possible reasons, provided no evidence for one or the other being true, picked the one you liked and assumed it was true.

SadisticNature
02-27-2010, 12:25 PM
Did you know that they are required to perform said trails three separate times?

A lot of medicines pass trials and then get pulled for safety reasons. So lowering standards to lower costs would be suicidal. Or do we want to forget about all those drugs that the drug companies have been sued over and stopped making for problems. After all these drugs got through testing as is without problems. If anything lowering the standards is going to raise costs because the companies will have more problematic drugs in the market and higher legal damages from said drugs, raising the price of every drug that company makes.

DuncanONeil
02-27-2010, 05:21 PM
"If it is then you have no basis for claiming the 4% of successful cases lack merit."

I made no such claim!


Either merit is determined by the legal system or it isn't. If it isn't, then claiming the 90% of cases that were dismissed have no merit is wrong (some might involve missed filing deadlines or off on a technicality decision). If it is then you have no basis for claiming the 4% of successful cases lack merit.

You have basically taken a list of possible reasons, provided no evidence for one or the other being true, picked the one you liked and assumed it was true.

DuncanONeil
02-27-2010, 05:27 PM
How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?


A lot of medicines pass trials and then get pulled for safety reasons. So lowering standards to lower costs would be suicidal. Or do we want to forget about all those drugs that the drug companies have been sued over and stopped making for problems. After all these drugs got through testing as is without problems. If anything lowering the standards is going to raise costs because the companies will have more problematic drugs in the market and higher legal damages from said drugs, raising the price of every drug that company makes.

SadisticNature
02-28-2010, 12:34 PM
How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?

If you have done no testing of the risks of the product you aren't able to produce the information that would allow an individual to make an informed choice. This would be comparable to making an "informed choice" about cigarette smoking in the 1920's. No one knew much if anything about the health effects so in fact people were making an uninformed choice. In the 1920's people would look at you like you were crazy if you said smoking had negative health effects.

The fact that smokers have won major lawsuits in the states suggests that drug companies would lose similar lawsuits if they don't carry out due diligence on their medications. Having a national standard does a lot to create a higher burden of proof for liability cases.

As for drugs that are in use in nearly every country these statistics can be misleading. For some drugs "nearly every country" means about 60% of the countries on Earth, keeping in mind a sizable portion have very lax standards (much of Africa for instance). In other cases, there are specific health risks that the government raises concerns about, often legitimately. Canada has had a similar situation where there were a few drugs that were approved in a lot of other countries. Some of them were involved in later problems, including voluntary withdrawals by the company and some legal issues.

Regarding legal immunity, I would point to Merck's Vioxx. Where the FDA decided what the drug did was so important they were willing to offer it protection from lawsuits on the basis of this condition and permission to continue providing it. The company decided the fact that people with a certain genetic condition would die from taking it, and no test existed for this genetic condition would do so much damage to its brand that even under these conditions it would not continue offering the drug.

Drug testing standards also limit the damage done by executives who look for short term profits increasing bonuses, at the expense of the long term health of the company. I strongly suspect at least some CEOs that needed to boost profit numbers or face losing their job would be inclined to take a risk on accelerating a drug to market, and possibly cut corners on tests if they weren't held to strict standards. It doesn't have to be every CEO or even most of them. But if even 1 in every 20 CEO's in this situation would do this then you'd be faced with huge problems.

On the other hand if the drug companies kill off a lot of people with shoddy products, people will be too scared to take medicines and health care costs will go down. I guess there is a plus side to everything. Nonetheless I ask you to forgive me for looking at the lead lining.

SadisticNature
02-28-2010, 12:42 PM
How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?

I think condemn to death is hyperbole. The main issue here is actually insurance coverage. You can get unapproved drugs by ordering them through mail order across the border. If there are issues with the drug the lack of FDA approval and the fact that you circumvented the countries regulations will protect the drug provider from liability.

DuncanONeil
03-02-2010, 06:29 PM
If you have done no testing of the risks of the product you aren't able to produce the information that would allow an individual to make an informed choice. This would be comparable to making an "informed choice" about cigarette smoking in the 1920's. No one knew much if anything about the health effects so in fact people were making an uninformed choice. In the 1920's people would look at you like you were crazy if you said smoking had negative health effects.

You really believe that the only entity that is honest and ethical is the Government? You actually believe that? Remember that the current Speaker promised the most ethical and honest ever. That really proved to be true!!
You really believe that people would "look at you like you were crazy if you said smoking had negative health effects." Even my father, born in 1901, called them coffin nails! Hence your statement is inaccurate.


The fact that smokers have won major lawsuits in the states suggests that drug companies would lose similar lawsuits if they don't carry out due diligence on their medications. Having a national standard does a lot to create a higher burden of proof for liability cases.

Again you assume that they do not engage in due diligence with out thousands of pages of Government regulations? And hundreds of hoops to jump through? Do you think aspirin should be removed from the market? Or Dihydrogenmonoxide?


As for drugs that are in use in nearly every country these statistics can be misleading. For some drugs "nearly every country" means about 60% of the countries on Earth, keeping in mind a sizable portion have very lax standards (much of Africa for instance). In other cases, there are specific health risks that the government raises concerns about, often legitimately. Canada has had a similar situation where there were a few drugs that were approved in a lot of other countries. Some of them were involved in later problems, including voluntary withdrawals by the company and some legal issues.

I believe that the data shows that most of the worlds drug come from American labs. And no I have not checked the figures. Besides there are drugs approved for use in the USofA that have the minor little side effect of DEATH. But essentially you are saying that a drug that exists and shown to have a beneficial effect CAN NOT be used by people in the US under ANY CIRCUMSTANCES.


Regarding legal immunity, I would point to Merck's Vioxx. Where the FDA decided what the drug did was so important they were willing to offer it protection from lawsuits on the basis of this condition and permission to continue providing it. The company decided the fact that people with a certain genetic condition would die from taking it, and no test existed for this genetic condition would do so much damage to its brand that even under these conditions it would not continue offering the drug.

Your subject not mine!!


Drug testing standards also limit the damage done by executives who look for short term profits increasing bonuses, at the expense of the long term health of the company. I strongly suspect at least some CEOs that needed to boost profit numbers or face losing their job would be inclined to take a risk on accelerating a drug to market, and possibly cut corners on tests if they weren't held to strict standards. It doesn't have to be every CEO or even most of them. But if even 1 in every 20 CEO's in this situation would do this then you'd be faced with huge problems.

Short term profits?!?! The drug equivalent of a copyright protects any company from competition for 10 years. You the concept of the greedy evil company is moot. As for one in 20 there are not that many in the country.


On the other hand if the drug companies kill off a lot of people with shoddy products, people will be too scared to take medicines and health care costs will go down. I guess there is a plus side to everything. Nonetheless I ask you to forgive me for looking at the lead lining.

If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!

DuncanONeil
03-02-2010, 06:36 PM
Nothing in the least hyperbolic in this. People in this country suffering terminal conditions are prevented from choosing any treatment that is available but not approved by the FDA for their condition.
Drugs that are approved by the FDA and found to be effective against something else are prohibited to be used for the second condition. Why? Because the FDA will not allow it to be so used!


I think condemn to death is hyperbole. The main issue here is actually insurance coverage. You can get unapproved drugs by ordering them through mail order across the border. If there are issues with the drug the lack of FDA approval and the fact that you circumvented the countries regulations will protect the drug provider from liability.

SadisticNature
03-03-2010, 04:11 PM
You really believe that the only entity that is honest and ethical is the Government? You actually believe that? Remember that the current Speaker promised the most ethical and honest ever. That really proved to be true!!
You really believe that people would "look at you like you were crazy if you said smoking had negative health effects." Even my father, born in 1901, called them coffin nails! Hence your statement is inaccurate.

Again you assume that they do not engage in due diligence with out thousands of pages of Government regulations? And hundreds of hoops to jump through? Do you think aspirin should be removed from the market? Or Dihydrogenmonoxide?



I believe that the data shows that most of the worlds drug come from American labs. And no I have not checked the figures. Besides there are drugs approved for use in the USofA that have the minor little side effect of DEATH. But essentially you are saying that a drug that exists and shown to have a beneficial effect CAN NOT be used by people in the US under ANY CIRCUMSTANCES.



Your subject not mine!!



Short term profits?!?! The drug equivalent of a copyright protects any company from competition for 10 years. You the concept of the greedy evil company is moot. As for one in 20 there are not that many in the country.



If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!

I'm not claiming the government is perfect or reputable. I'm saying that they can better set standards for testing of drugs then the drug companies themselves who have competing interests. Suggesting the drug companies themselves would be able to do a better job at setting the standards would be akin to suggesting the fox should guard the chicken coup.

And yes I believe, with evidence that some powerful individuals in any business take shortcuts for person gain at the expense of others, including customers, other employees and the companies they work for. I'm not saying this is everyone, but it does exist in every business. Unfortunately we need regulations and they need to be enforced. Madoff got reported to the SEC 10 years before they did anything, if they actually bothered to do their jobs a lot of people wouldn't have lost their life savings to a ponzi scheme.

Things like fraud, cooking the books, and other loopholes and exploits happen all the time. People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time. It may only be a small percentage of people in their worst moments, but people do need protection from said individuals.

Do you honestly believe that every single individual who needs to bump up the revenue figures for the quarter or face losing their job would choose to lose the job over releasing a drug that will work and sell, but may have serious side effects? I think history shows that at least some individuals will choose to release the drug and save the job. Only regulations disallowing this choice (need proper testing to be able to release the drug) save us from these individuals. And these individuals are out there even Bush or Cheney referred to them as "a few bad apples".

The fact is there are people who behave badly, many of them very successful. The regulations can be a pain in the ass for those who behave properly 100% of the time, but that doesn't mean they aren't needed. All it takes is one bad decision in one moment of weakness to cause a serious problem. The regulations do a lot to prevent that.

I'm not saying the drug regulations are perfect, they aren't. But just because they have some problems doesn't mean the solution is to scrap them entirely. That would be like saying the problem with Enron is the damn government financial regulations, they should be able to cook their books if they want to.

Your father born in 1901 may have called them coffin nails, but did he call them that with full intent in 1921? My great grandmother was born at a similar time period, and had all sorts of bad things to say about cigarettes later in life. The fact is in the 1920's and 1930's she smoked, and didn't know a thing about the bad effects of cigarettes. That information was not publicly available until much later. Just because someone who was around in 1920 or 1930 says something in 1960 or 1970 about a product doesn't mean they felt that way in 1920 and 1930.

SadisticNature
03-03-2010, 04:16 PM
You continue to talk about the FDA as if it has this magical power to stop people from ordering drugs by mail across the border and getting them then taking them, and that by doing so it is condemning people to death. The fact is if you want to use drug X to treat disease Y you can order it by mail, pay for it yourself and do so.

You have done nothing to address this point in your statement, rather you continue to claim the FDA is condemning people to death.

As for 1st condition vs 2nd condition:
(i) There needs to be evidence the drug actually works for condition 2.
(ii) There needs to be consideration of side effects and severity of condition. A drug that sometimes causes death might be acceptable for treating a terminal form of cancer, but if the manufacturer also wants to use it to treat headaches that might raise alarm bells.


Nothing in the least hyperbolic in this. People in this country suffering terminal conditions are prevented from choosing any treatment that is available but not approved by the FDA for their condition.
Drugs that are approved by the FDA and found to be effective against something else are prohibited to be used for the second condition. Why? Because the FDA will not allow it to be so used!

SadisticNature
03-03-2010, 04:18 PM
You argue that I am wrong to assume that it is not the case that every individual will carry out proper due diligence without regulation. I'd argue the onus is on you to prove that they will.

The fact is the current system has regulations because it requires the companies to carry out due diligence for the benefit of the citizenry. Your unsubstantiated claim is that without the regulations 100% of companies will do this anyways 100% of the time. If you could prove this I'd have no problem with abolishing the regulations, however both history and human nature argue to the contrary.

DuncanONeil
03-05-2010, 07:45 AM
I'm not claiming the government is perfect or reputable. I'm saying that they can better set standards for testing of drugs then the drug companies themselves who have competing interests. Suggesting the drug companies themselves would be able to do a better job at setting the standards would be akin to suggesting the fox should guard the chicken coup.

With everything having to be "approved" by the FDA, anything that makes it through the process is considered safe by the people! Since the trials are actually conducted by the producer it is easy to fudge the data if youo so choose.
The fox/hen house is not a suitable analogy. The fox is seeking food, i.e. survival. In business if you "eat" your customers you are out of business. Were "certification" voluntary it is easy to surmise that people will, except in a very few cases, choose that "certified" product. Further if the Government is not directly involved it would likely be quicker and less expensive.



And yes I believe, with evidence that some powerful individuals in any business take shortcuts for person gain at the expense of others, including customers, other employees and the companies they work for. I'm not saying this is everyone, but it does exist in every business. Unfortunately we need regulations and they need to be enforced. Madoff got reported to the SEC 10 years before they did anything, if they actually bothered to do their jobs a lot of people wouldn't have lost their life savings to a ponzi scheme.

"(L)ost their life savings to a ponzi scheme." You mean like Social Security? Yes, bad people do exist. But does that mean that the rest must suffer in an attempt to control the few? It may seem to be not appropriate, but is indicative of the Government thought process. People know that riding a motorcycle without a helmet poses additional risk, They choose to do so. Yet various governments have enacted laws that REQUIRE motorcycle riders to wear helmets. I live in such a place and yet see many riders without helmets. To carry your logic into this arena all manufacturers should be required to make helmets part of the motorcycle.
Were people to have a choice between a "tested" & "certified" product vs one that is not they will choose that which they believe is best for them. If that is the "tested" & "certified" than those concerns that elected to forego such certification would either go out of business or submit to testing.



Things like fraud, cooking the books, and other loopholes and exploits happen all the time. People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time. It may only be a small percentage of people in their worst moments, but people do need protection from said individuals.

First of all a "loophole" implies that regulation is already in place. That is a major problem with regulation! "People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time." I suspect that this is a historical event. The second sentence implies that inspectors are being killed even today!



Do you honestly believe that every single individual who needs to bump up the revenue figures for the quarter or face losing their job would choose to lose the job over releasing a drug that will work and sell, but may have serious side effects? I think history shows that at least some individuals will choose to release the drug and save the job. Only regulations disallowing this choice (need proper testing to be able to release the drug) save us from these individuals. And these individuals are out there even Bush or Cheney referred to them as "a few bad apples".

Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!



The fact is there are people who behave badly, many of them very successful. The regulations can be a pain in the ass for those who behave properly 100% of the time, but that doesn't mean they aren't needed. All it takes is one bad decision in one moment of weakness to cause a serious problem. The regulations do a lot to prevent that.

Regulations do nothing to prevent; "people who behave badly" or "one bad decision in one moment of weakness to cause a serious problem". All the regulation can do is provide an additional means to punish that particular individual!
Most regulations on business actually punish said business before the fact!



I'm not saying the drug regulations are perfect, they aren't. But just because they have some problems doesn't mean the solution is to scrap them entirely. That would be like saying the problem with Enron is the damn government financial regulations, they should be able to cook their books if they want to.
Interesting that the support for drug regulation is the problems in a non-drug concern!
If there are problems in the "system of safety" than the "system of safety" needs to be overhauled. Not added to!
Kind of like the failed health bills in Congress. The President's solution? Add to the bill, make it larger and more complicated!



Your father born in 1901 may have called them coffin nails, but did he call them that with full intent in 1921? My great grandmother was born at a similar time period, and had all sorts of bad things to say about cigarettes later in life. The fact is in the 1920's and 1930's she smoked, and didn't know a thing about the bad effects of cigarettes. That information was not publicly available until much later. Just because someone who was around in 1920 or 1930 says something in 1960 or 1970 about a product doesn't mean they felt that way in 1920 and 1930.

Can't accept that rationale. With out a serious research effort it is hard to prove, but the term "coffin nails" for cigarettes as synonymous. There is evidence that prior to "coffin nail" they were known as "coffin tacks" a term in use in the 19th century.

DuncanONeil
03-05-2010, 07:53 AM
It is illegal to purchase drugs that are not approved by the FDA.
As for cross use drugs. Doctors have patients that have more than one condition. One of which they do not have medication for, or they drug they are taking is less than effective. Prescribed a new med for a different condition that presents efficatious treatmet for the previous condition is of no value to the FDA. Said drug must go through the ENTIRE approval process. As to people dying. People with terminal conditions are being prevented from attempting meds or treatments that have been shown effective for their condition. They are prevented, especially in the treatment arena (because there is a doctor involved, mostly) because the med or treatment is not approved. No consideration that these people, dying, freely choose to accept the chance of relief. The ultimate case of you are too stupid to decide for yourself!


You continue to talk about the FDA as if it has this magical power to stop people from ordering drugs by mail across the border and getting them then taking them, and that by doing so it is condemning people to death. The fact is if you want to use drug X to treat disease Y you can order it by mail, pay for it yourself and do so.

You have done nothing to address this point in your statement, rather you continue to claim the FDA is condemning people to death.

As for 1st condition vs 2nd condition:
(i) There needs to be evidence the drug actually works for condition 2.
(ii) There needs to be consideration of side effects and severity of condition. A drug that sometimes causes death might be acceptable for treating a terminal form of cancer, but if the manufacturer also wants to use it to treat headaches that might raise alarm bells.

DuncanONeil
03-05-2010, 08:00 AM
I do not argue that 100% of companies will do the right thing, as you freely admit.
Using history as an argument is a bit weak in the modern age, I submit. It is information that allows people to make an informed decision. Information is substantially more available today, than in the past.
Few regulations are designed to require due diligence. They are set up for the purpose of establishing what is considered appropriate and for the purpose of punishment.
Again the actual proposal I made was to do away with the FDA and replace it with something that could move in a manner akin to, say, a motorcycle than a locomotive.


You argue that I am wrong to assume that it is not the case that every individual will carry out proper due diligence without regulation. I'd argue the onus is on you to prove that they will.

The fact is the current system has regulations because it requires the companies to carry out due diligence for the benefit of the citizenry. Your unsubstantiated claim is that without the regulations 100% of companies will do this anyways 100% of the time. If you could prove this I'd have no problem with abolishing the regulations, however both history and human nature argue to the contrary.

Thorne
03-05-2010, 08:10 AM
Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!

There's a rather bizarre reason for this. Manufacturer's are required to show as a side effect any reaction which test subjects had while taking the medication, even if it cannot be shown that the medication was responsible! Unless they can show absolutely that the medication did not cause or contribute to the side effect, they must list it. Trying to track down every minor complaint that test subjects make would be prohibitively expensive. It's easier to just record their results as possible side effects.

DuncanONeil
03-06-2010, 09:32 AM
But that requirement in and of itself also seems to support the previous supposition that we are not being served well by the process.
Seems that an autopsy, while perhaps not being able to prove drug induced death, should be capable of determine if death cause is not related to drug ingestion.
Does that mean if a member of the drug group dies and a member of the control group dies it is not a side effect of the drug?


There's a rather bizarre reason for this. Manufacturer's are required to show as a side effect any reaction which test subjects had while taking the medication, even if it cannot be shown that the medication was responsible! Unless they can show absolutely that the medication did not cause or contribute to the side effect, they must list it. Trying to track down every minor complaint that test subjects make would be prohibitively expensive. It's easier to just record their results as possible side effects.

Thorne
03-06-2010, 10:19 AM
But that requirement in and of itself also seems to support the previous supposition that we are not being served well by the process.
Seems that an autopsy, while perhaps not being able to prove drug induced death, should be capable of determine if death cause is not related to drug ingestion.
Does that mean if a member of the drug group dies and a member of the control group dies it is not a side effect of the drug?

That depends. Yes, it may be possible to determine if the drug caused death. But what if, for example, a person in the test group has a massive coronary and dies, but no one in the control group dies? Was the death caused by the drug? Probably not, but can you be sure? It's possible that there is some unknown reaction which the drug has with persons of a certain genetic type, say, which weakens vessels in the heart. There may be no way to determine this in these studies, but there's no way to say that the drug did not cause it, either. It's safer to show that death might be a side effect.

DuncanONeil
03-06-2010, 10:25 AM
Maybe!


That depends. Yes, it may be possible to determine if the drug caused death. But what if, for example, a person in the test group has a massive coronary and dies, but no one in the control group dies? Was the death caused by the drug? Probably not, but can you be sure? It's possible that there is some unknown reaction which the drug has with persons of a certain genetic type, say, which weakens vessels in the heart. There may be no way to determine this in these studies, but there's no way to say that the drug did not cause it, either. It's safer to show that death might be a side effect.

SadisticNature
03-07-2010, 11:21 AM
With everything having to be "approved" by the FDA, anything that makes it through the process is considered safe by the people! Since the trials are actually conducted by the producer it is easy to fudge the data if youo so choose.
The fox/hen house is not a suitable analogy. The fox is seeking food, i.e. survival. In business if you "eat" your customers you are out of business. Were "certification" voluntary it is easy to surmise that people will, except in a very few cases, choose that "certified" product. Further if the Government is not directly involved it would likely be quicker and less expensive.




"(L)ost their life savings to a ponzi scheme." You mean like Social Security? Yes, bad people do exist. But does that mean that the rest must suffer in an attempt to control the few? It may seem to be not appropriate, but is indicative of the Government thought process. People know that riding a motorcycle without a helmet poses additional risk, They choose to do so. Yet various governments have enacted laws that REQUIRE motorcycle riders to wear helmets. I live in such a place and yet see many riders without helmets. To carry your logic into this arena all manufacturers should be required to make helmets part of the motorcycle.
Were people to have a choice between a "tested" & "certified" product vs one that is not they will choose that which they believe is best for them. If that is the "tested" & "certified" than those concerns that elected to forego such certification would either go out of business or submit to testing.




First of all a "loophole" implies that regulation is already in place. That is a major problem with regulation! "People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time." I suspect that this is a historical event. The second sentence implies that inspectors are being killed even today!




Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!




Regulations do nothing to prevent; "people who behave badly" or "one bad decision in one moment of weakness to cause a serious problem". All the regulation can do is provide an additional means to punish that particular individual!
Most regulations on business actually punish said business before the fact!



Interesting that the support for drug regulation is the problems in a non-drug concern!
If there are problems in the "system of safety" than the "system of safety" needs to be overhauled. Not added to!
Kind of like the failed health bills in Congress. The President's solution? Add to the bill, make it larger and more complicated!




Can't accept that rationale. With out a serious research effort it is hard to prove, but the term "coffin nails" for cigarettes as synonymous. There is evidence that prior to "coffin nail" they were known as "coffin tacks" a term in use in the 19th century.

To use your motorcycle example I'm not arguing for attaching the helmet to the motorcycle or having it come with the motorcycle I'm arguing for not abolishing the law that requires helmets.

As for suffering, it is pretty clear to me that rules that mitigate the suffering caused by unscrupulous or negligent actions do far less harm to the general populous than the suffering that is caused when those rules are not in place or enforced.

Regarding the mining fraud it was a historic event, regarding loopholes it does happen all the time. Probably even right now there is some company exploiting a loophole in some regulation as I type. As far as the drugs go, there are already regulations in place.

As for regulations doing nothing to prevent bad behavior, when is the last time a drug company released a drug into the US market without adequate testing and pulled it due to easily anticipated consequences that would have shown up in the studies they never conducted? This is exactly the behavior your proposed changes in the rules would allow, that I suggest needs to be prevented. As far as I can tell the FDA rules have successfully prevented this.

DuncanONeil
03-07-2010, 06:07 PM
I objected to the mining reference precisely because it was historical!

If the FDA, and their regulations were so effective there would never be a recall of medications.

If you go back and read my original post I did not advocate for complete anarchy in the production of medications.


To use your motorcycle example I'm not arguing for attaching the helmet to the motorcycle or having it come with the motorcycle I'm arguing for not abolishing the law that requires helmets.

As for suffering, it is pretty clear to me that rules that mitigate the suffering caused by unscrupulous or negligent actions do far less harm to the general populous than the suffering that is caused when those rules are not in place or enforced.

Regarding the mining fraud it was a historic event, regarding loopholes it does happen all the time. Probably even right now there is some company exploiting a loophole in some regulation as I type. As far as the drugs go, there are already regulations in place.

As for regulations doing nothing to prevent bad behavior, when is the last time a drug company released a drug into the US market without adequate testing and pulled it due to easily anticipated consequences that would have shown up in the studies they never conducted? This is exactly the behavior your proposed changes in the rules would allow, that I suggest needs to be prevented. As far as I can tell the FDA rules have successfully prevented this.

SadisticNature
03-09-2010, 09:33 AM
By definition you are actually advocating for anarchy in drug production, namely the removal of all regulations pertaining to it.

Anarchists believe if we get the laws and rules out of the way we would all get along a lot better. I however don't really buy that.

As for the regulations not stopping every bad drug, of course they don't. Some problems are almost impossible to detect, and if you had a standard that stopped every problem drugs would come to the market far slower, and testing would be much more expensive. The current system is a balance of risk and payoff. It has some recalls due to problems, but detects far more in testing.

Your proposed system says "the regulations aren't perfect lets not have any at all".

DuncanONeil
03-10-2010, 10:14 AM
"If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!" (message 338)

How is the above advocating for either anarchy or abolishment of the FDA?


By definition you are actually advocating for anarchy in drug production, namely the removal of all regulations pertaining to it.

Anarchists believe if we get the laws and rules out of the way we would all get along a lot better. I however don't really buy that.

As for the regulations not stopping every bad drug, of course they don't. Some problems are almost impossible to detect, and if you had a standard that stopped every problem drugs would come to the market far slower, and testing would be much more expensive. The current system is a balance of risk and payoff. It has some recalls due to problems, but detects far more in testing.

Your proposed system says "the regulations aren't perfect lets not have any at all".

SadisticNature
03-10-2010, 12:34 PM
So you want to leave a token organization with no real enforcement powers, and remove all the regulations. Anarchy is the absence of regulation ergo this is anarchy.


"If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!" (message 338)

How is the above advocating for either anarchy or abolishment of the FDA?

DuncanONeil
03-13-2010, 08:51 AM
Then I must presume that you favor all choice to be regulated by the Government. Irrespective of the costs involved.
Remember, all restaurant's in Judge Dredd's future were Taco Bell.


So you want to leave a token organization with no real enforcement powers, and remove all the regulations. Anarchy is the absence of regulation ergo this is anarchy.

SadisticNature
03-13-2010, 09:00 AM
I know that we have higher standards in Canada regarding meat quality so Taco Bell has to use a different supply chain. And even Americans say the Taco Bell's are better here so those standards appear to be working!

I don't favor all choice being regulated, and I do believe in analysis of costs and risks vs benefits. I just think you're advocating no regulation at all, because you're against it in the areas that most need it (health and financial).



Then I must presume that you favor all choice to be regulated by the Government. Irrespective of the costs involved.
Remember, all restaurant's in Judge Dredd's future were Taco Bell.

denuseri
03-13-2010, 11:09 AM
Should placebos be illegal accross the board or not? Some say yes and some say no. Ok, big deal, opinions stated, shall we perhaps move on then and purpose some actual solutions?

How does one regulate something that requires the patient have no idea its being used outside of whats allready in place internally at medical ethics review boards?

I purpose that we could simpley have all patients sign a waiver stating that placebos may be used by diagnosticans as they deem appropriate as part of standard medical paperwork at all facilities, as was allways "assumed" to be part of a medical practicions own ethical requirments before big money insurance companies and lawyers got into the mix and ruined everything.

SadisticNature
03-13-2010, 03:43 PM
Should placebos be illegal accross the board or not? Some say yes and some say no. Ok, big deal, opinions stated, shall we perhaps move on then and purpose some actual solutions?

How does one regulate something that requires the patient have no idea its being used outside of whats allready in place internally at medical ethics review boards?

I purpose that we could simpley have all patients sign a waiver stating that placebos may be used by diagnosticans as they deem appropriate as part of standard medical paperwork at all facilities, as was allways "assumed" to be part of a medical practicions own ethical requirments before big money insurance companies and lawyers got into the mix and ruined everything.


I like this solution. Allows individual choice, those who want placebo's can sign up for them, and those of us who actually want the truth don't have lies forced down our throats.

DuncanONeil
03-13-2010, 09:08 PM
Perhaps if we truly educated our people we would not have a need for a nanny to tell us when the stove is hot!
The problem is, largely, that the regulations that get written are not always reasonable. In addition regulation today is most often predicated on the supposition that people are too stupid to bother with doing any thinking. For example; coffee is hot, keep away from sensitive parts of the body! But since somebody was too (insert appropriate adjective) to secure the coffee money has to be spent to make a warning that those very same people will not read! Same goes for signing contracts.

The Taco Bell thing was an allegory. Stole it from a movie!


I know that we have higher standards in Canada regarding meat quality so Taco Bell has to use a different supply chain. And even Americans say the Taco Bell's are better here so those standards appear to be working!

I don't favor all choice being regulated, and I do believe in analysis of costs and risks vs benefits. I just think you're advocating no regulation at all, because you're against it in the areas that most need it (health and financial).

DuncanONeil
03-13-2010, 09:11 PM
What do you call three lawyers, or solicitors as the case may be, at the bottom of the ocean?


Should placebos be illegal accross the board or not? Some say yes and some say no. Ok, big deal, opinions stated, shall we perhaps move on then and purpose some actual solutions?

How does one regulate something that requires the patient have no idea its being used outside of whats allready in place internally at medical ethics review boards?

I purpose that we could simpley have all patients sign a waiver stating that placebos may be used by diagnosticans as they deem appropriate as part of standard medical paperwork at all facilities, as was allways "assumed" to be part of a medical practicions own ethical requirments before big money insurance companies and lawyers got into the mix and ruined everything.

DuncanONeil
03-13-2010, 09:12 PM
But would that not then defeat the purpose of them?


I like this solution. Allows individual choice, those who want placebo's can sign up for them, and those of us who actually want the truth don't have lies forced down our throats.

denuseri
03-13-2010, 10:17 PM
No not nessesarally, all patients would sign a wavier giving the physician the freedom to choose if and when a placebo was used. The patient would never need know until the treatment was over. Just like they do in medical trials.

DuncanONeil
03-14-2010, 04:42 PM
I still suspect that if the patient knew they signed this the knowledge gleaned from use of placebo outside of trials will be compromised.


No not nessesarally, all patients would sign a wavier giving the physician the freedom to choose if and when a placebo was used. The patient would never need know until the treatment was over. Just like they do in medical trials.

denuseri
03-14-2010, 08:29 PM
Why would it?

SadisticNature
03-15-2010, 03:43 PM
The way I heard it was "What do you call three trombones at the bottom of the ocean?" and the answer was "A good start."


What do you call three lawyers, or solicitors as the case may be, at the bottom of the ocean?

SadisticNature
03-15-2010, 03:46 PM
When you sign up for your physician you sign one of two statements that they attach to the record.

1. When the physician feels the best course of action is a placebo they can prescribe it without telling me.

2. I do not want the physician to prescribe me placebo's regardless of circumstances.

If you sign 1. it is still the case that the vast majority of the time you get real medicine not placebo's, so you would not need to be suspicious of placebo's.


I still suspect that if the patient knew they signed this the knowledge gleaned from use of placebo outside of trials will be compromised.

DuncanONeil
03-20-2010, 11:15 AM
Why would it?

Since they know the doctor may have given them a "sugar pill" they will never expect it to help. The knowledge learned by the doctor in giving a "sugar pill" no longer exists. They can no longer rule out a set of symptoms being not medically relevant.

DuncanONeil
03-20-2010, 11:16 AM
The way I heard it was "What do you call three trombones at the bottom of the ocean?" and the answer was "A good start."

How about three Congressmen??

DuncanONeil
03-20-2010, 11:18 AM
It still remains that if you know of the possibility the Placebo effect is is attenuated. Then the doctor can not rule out anything.
Besides if the language you propose is the language, I envision no one picking item 1


When you sign up for your physician you sign one of two statements that they attach to the record.

1. When the physician feels the best course of action is a placebo they can prescribe it without telling me.

2. I do not want the physician to prescribe me placebo's regardless of circumstances.

If you sign 1. it is still the case that the vast majority of the time you get real medicine not placebo's, so you would not need to be suspicious of placebo's.