These are great questions. Doctors shouldn't lie to patients but they don't always have to say every exact thing that is going on either. It is unethical to purposely mislead a patient, even if you think it is for their greater good.
Regarding #2 and #3, the doctor could risk practicing bad medicine if he really doesn't know what he is doing and is recommendation bad treatments that may not work or that could even harm patients. He could risk a malpractice suit and would be questioned by his peers who could push forward an investigation by the state medical board - but not so much on ethics violation but in not properly practicing medicine. So I would say it would be going out on a limb unless the treatment was something like medical marijuuana where there was at least some significant faction of the population, some significant number of mainstream physicians and members or congress, elected officials who have been if favor of it. I have no opinion on the marijuana issue but used it as an example. If the doctor wants to recommend something that is out of the mainstream and very iffy, not fda approved, not available in US then I think that could be risky for his good standing and could be unethical as well. Wish I could tell you the proper ethics guru to contact.
I am following your discussion intently as I feel I was placed in a similar situation. I am presently going through the referral process for second opinions on answers I could perhaps have received months ago with more candid conversations (on their part) with my doctors.
In your research, did you find much literature on ibopamine's effects on hypotony, post vitreoretinal surgery? If you have time to give me any references, I would greatly appreciate it. If you do not, I understand that perhaps you are too busy, and that you may not be able to.
Just curious, my ciliary body has largely atrophied, so I am sot sure the drops were relevant to me at all. However, the MD in Italy said not to worry about my CB, that I ipopamine would still help. He also had a hard time understanding why my doctor was uncomfortable with with the arrival of the drops in the US. I think he did not understand about FDA.
Can you imagine, but this doctor and I spent about 3 weeks, round the clock emails and telephone calls, including communication with the FDA, customs, drug distributors, Fed Ex, USPS, etc.,? I paid costs of medicine and shipment, but he spent an enormous amount of time helping me. A young doctor, with a busy practice, and a young family. How kind!
I read in Newsweek about 15 years ago that MD/pt. collaboration was the current way to view medical treatment.I thought most young doctors would see things this way by now. Apparently not. With serious eye conditions especially, patient should be listened to
My last comment has nothing in particular to do with experimental treatments, just had to do with my treatment experience.
You would also think that retinal specialists would explore the idea of having a psychologist or a psychiatric nurse/social worker on hand in serious cases, but I have not heard of a single practice adopting this kind of approach. A pain doctor I saw did this, and I am not sure that the practice had successfully integrated the procedure, but the idea is nevertheless a sound one.
Thanks for listening.
Thank you so much for your posts - you learn something new every day. I have just spend quite some time researching ibopamine and don't know why it is not fda approved in the us. Perhaps no one has submitted it for approval - which is very costly. This will obvioiusly be a niche product and probably not very profitable to make. I'm certain that it may have some systemic side effects similar perphaps to brimonidine or phenylephrine but don't have a clear idea of its overall safety. Thanks, again. It takes time, but if the drug is found to be safe and useful, it will eventually be available.
Just thought of it - is it tacrolimus??
It is definitely not FDA approved for ocular use in US. And just to be clear I have no comment on it's usefulness, or safety and do not condone it's ocular use.
Are you talking about drops similar to restasis - I am blanking on the name - but used for chronic excema, severe blepharitis, severe allergies but used as an alternative to steroids? That's about the only drop that I can think of of that might be sought after by americans who wanted to used something non-fda approved.
Those are great answers. I appreciate your feedback. Sometimes patients must face horrible letdowns about their doctors. It is very hurtful, especially with serious conditions. That it why it is so great to get sensitive answers from a doctor like you.
Two doctors, in the same office, encouraged the patient to use them. Maybe the second doctor did not realize that they were non-FDA approved. The drug is used in many countries. Maybe the second doctor thought they were covered by a clinical study. I read today that you can do a clinical study on one patient, but that there is a lot of hassle involved.
The drugs passed US customs, btw., because of the serious condition. A doctor in another country sent them. I guess this makes no difference.
The first doctor said he could not say much, or he would get in a great deal of trouble. He insisted that he did not know much about them. But he should be reading about the topic; it seems to me that he should know about the latest medications, world wide. I think he said he did not know much to protect himself, and that is OK. The patient was eager to protect the doctor. In fact, another doctor asked the patient if this doctor told the patient about the drugs. The patient avoided an answer, to protect the doctor.
So it seems strange that he encouraged the patient to use them. He was furious, however, when the drugs arrived, Even though he had brought them up, he really did not want the patient to get them, it seems. He turned on the patient, was verbally abusive, etc. From all this, seems like the doctor is kind of a mess. I hate to say this about a doctor. But he put the patient on a horrible emotional roller caster ride. The patient had respected him and admired him, had even become fond of him. That can happen, you know, when patients are very grateful to their doctors, and especially with long-term doctor/patient relationships.
Are physician-peers the only ones who can bring about an investigation?
Thank you very much.
It is hard to realize that medical care can sometimes do psychological harm, as well as heal physically.
The patient sees another doctor now, but wishes for some kind of positive resolution to this, one that would benefit everyone. There has been no resolution at all.
Your keen and sensitive response caused me to re-think my questions, and to try to avoid any legal questions and, as much as possible, to center on ethics.
1. I believe that I know the answer to my first question: Is it ethical for a doctor to lie to a patient about the patient's condition/deny validation to the patient of changes in the patient's condition, especially when the doctor/patient goal of healing could be advanced by the doctor's validation of information that the patient already knows?
I believe this it is unethical, especially when this information could help the patient's final outcome. Nothing, I beleive, could justify this.
Maybe #2 and #3 are too legal. I tried to find them under AMA, but I have not been able to. If they are too legal, perhaps you could direct me where to look, in AMA guidelines, if you can do so.
2. A patient asks a doctor if the doctor knows of any medication/treatment that will help his very serious condition. Is a physician allowed to introduce the existence of a non-FDA-approved drug to a patient, and to tell the patient of the country where this medication can be obtained?
3. If the patient obtains the medication independently, is the doctor allowed to encourage the patient to use it? If he encourages the patient, is he going out on a limb?
Is it true that the physician cannot give the patient additional information about the drug, or talk to the patient at length about it?
I hope that I have stated my questions clearly.
I don't know a specific site. I would be glad to give my opinion. I've been through years of different ethics courses in college and med school and residency - and still try to keep abreast of current issues. I also know that Dr. Hagan is interested in the field of ethics - we deal with issues every day.
Yes, I can search practically anything through my university. I found the same three e articles I had found before. I have reviewed a lot of literature, and there is not much on the topic of ibopamine/hypotony/vitreoretinal surgeries. In other eye treatment areas, such as glaucoma and uveitis, there is a lot..
If you have time you can look on pubmed to view abstracts from medical journals. To view the entire articles requires a subsription, however.
I am also aware that the most prominant influence on my life right now is the trauma of the vision loss. But it is hard not to focus on prevention of more loss on my part or on the part of others.
However, getting through the trauma and continuing the work that is my life is also really important.
I am sorry that you have experienced this frustration and lack of help. My doctor did not listen to me at the most crucial part of my care. Yet he was "not there" with me (or not there at all), and I think he never really gave it a thought, even when I beat him a little with this fact, because his concern was always himself and "the retina business" as he called it.
I am not saying that all doctors have this particular mindset, but I have heard that retinologists can rarely stay with (concentrate on) anything long, except their work. This was from a person who does practice management with many of these doctors. Their work is technology, surgical procedures, etc.) It is, on the other had, impossible to pin it all down, because they are in such a different place. But I hope I make sense.
I hope you get some better answers soon and feel more resolution, and thanks for much for your comment.
Thanks very much for your responses.
Can you say what kinds of systemic effects these other drugs have? I can look it up, but I cannot read the literature with the point of view, education and experience of a doctor.
Any thought on whether the doctor can be exonerated, because the FDA personnel approved the entry of the drops to the US (according to FDA policy, not regulations), because of a serious condition and BECAUSE he was supervising treatment.
As for your research, you confirm my speculation that doctors should try to be aware of drugs like this.
The drops are ibopamine, called Trasyl in Italy. Some doctors tell me they have never heard of them. But the drug ibopamine has been used for the heart for years...and years.
They are used to test for glaucoma, for hypotony from uveitis, and for hypotony resulting from vitreal surgery...and the literature on the last is scarce.
I understand, you make no qualitative remarks on any of these.
I wanted to add tha FDA personnel at US customs allowed the drug to enter the US, because the condition was seroius and because the doctor's name was on the package, as the person supervising the treatment. The doctor's OFFICE, not him personally, gave permission for his name to be on the package. I do not know if this exonerates the doctor's having told the patient about the drug, in terms of medical ethics..
This is a guideline the FDA uses; it is not a law. I think this is getting complicated, because he made suggestions using the drops, but said that he could not discuss it at length.