Have You Consented to Drug Risks?

I was told about a surgery that I didn't opt for. I did sign a surgical release for for another surgery and a second one too but not the third. I have the forms in my possession. The surgeons went ahead and did the surgery that I did NOT sign for and ignored the informed consent for surgery. So I ended up getting surgery that was both inappropriate and that had not been approved by my health provider. This was at OHSU a teaching university..... I was and am devastated and appalled that they could and would do that to unsuspecting persons.

Is this a normal procedure for teaching universities?

PEOPLE'S PHARMACY RESPONSE: THIS IS NOT NORMAL AND WAS PROBABLY AN ERROR RATHER THAN A DELIBERATE OVERRIDE OF YOUR WISHES. YOU SHOULD REQUEST AN EXPLANATION.

I have quite a history of medical problems, going back to 1997 when I was diagnosed and surgically treated for an aortic aneurysm. This has been followed by a cancerous GIST, cardiac myopathy, AF, & hypertension. I have been on a lot of medications over the years, but not once have the doctors counseled on the risks. Because of time constraints, I believe that it is up to the patient to read the inserts from the pharmacy, and the info on the Internet. Then they should question the doctors. This is why docs will usually give you some free samples to see how well you tolerate the med.

Also, many drugs have a very long list of possible side effects and warnings. The doctor could not possibly talk about all of them, let alone remember them. I am taking Gleevec, which has many possible side effects.

I agree with most of what Ken K. says. The patient should question the doctor about any new medications, but what is the Doctors responsibility? One of the fundamental oaths that doctors take is "To Do No Harm." I categorically disagree that because of time constraints, in office doctors are too busy to explain to the patient the potential side effects of a new drug they are prescribing. It's bad medical practice and the doctor is leaving himself open to litigation in the event of a severe problem due to patient reaction to the medication.

The doctor is or should be aware of what medications the patient is currently taking and should know if there are any drug interactions or contraindications for this new drug. Implying that the responsibility for determining the possible side effects of a new drug is up to the patient is patently absurd. I do agree that the patient for his or her own protection should ask the doctor questions about the new drug, but the responsibility weighs heavy on the Doctor, not the patient.

What about elderly people who are at the mercy of the Doctor? They may be bed ridden with no access to a computer or the Internet. I agree that there are instances such as in Hospital situations or Emergencies where the Doctor may not have the time to explain to the patient all the side effects of the medication they are administering, but in a Doctors office situation, there is no excuse for the doctor not to make an attempt to discuss potential side effects of a new drug with the patient. The Doctor / Patient relationship is a symbiotic relationship, but the Doctor should always be the controller.

Because of my fibromyalgia and other health problems, I've been on a very long list of drugs over time given to me by a number of physicians. At no time, did any of those doctors ever bring up the subject of side effects. Any such discussions have always been initiated by me. Some of the doctors will take the time to discuss those concerns with me, and others have just told me to take the medicine - that I need it, especially with statins, and have not even allowed me the dignity of having legitimate concerns.

There is no consent other than staying with those doctors and picking up the medications. I live in a rural area where it is difficult to find a doctor who will take my concerns seriously.

A follow up from Ken K. There are a lot of scenarios where the patient is incapable of asking questions or carrying on an intelligent conversation. Examples: The very sick, the young, the elderly, the passive personality, the non-English speaking person, etc. This brings up a separate topic: Somebody has to become the patient's advocate whether in the doctor's office or in the hospital. And I repeat that many medications have so many warnings of side effects, that nobody would take any of them.

With regards to V.S. statement "I live in a rural area where it is difficult to find a doctor who will take my concerns seriously." It may be difficult but it's not impossible and if a doctor will not take the time to discuss the side effects of a new medication with you, particularly after you ask him, then I suggest you get rid of him and find a doctor who will treat you with care and respect.

I absolutely agree that there are patients who are not capable of asking questions or carrying on an intelligent conversation and that in their case there is a definite need for a patient advocate. In all major hospitals there are patient advocates, but in a doctors office unless the patient is accompanied by someone who can act as advocate for them, the patient advocate rightly or wrongly is the doctor or attending nurse. The Doctor cannot abdicate his responsibility to the patient; and part of his responsibility is to explain the side effects of any new drug he is administering to the patient or the patients advocate if one is present.

As far as the statement "And I repeat that many medications have so many warnings of side effects, that nobody would take any of them." I suspect some of these warnings are written by lawyers to prevent lawsuits and most warnings are generic patient warnings. Each patient is an individual case and many of these warnings may not apply to a specific individual patient's condition or history.

Only the doctor familiar with the patient's medical conditions and various medications can determine with any degree of confidence whether or not a drug is correct for the patient based on his familiarity with the drug and drug interaction warnings. That is one of the reasons for the Physicians Desk Reference. If you read all the warnings about bleeding and Aspirin you would never take an Aspirin, yet millions of people worldwide take Aspirin with no problem, while a very small group will occasionally have complications.

We have to calm down and use our common sense instead of letting fear take hold. I repeat, that in the relationship between Doctor and Patient, the Doctor because of his position as healer is in control and has a responsibility to the patient to provide the best care he or she is capable of. If the Doctor doesn't do this then get rid of the doctor and find one that will live up to his or her oath and responsibility.

There is a law called the "learned intermediary doctrine" that unfairly places the obligation to warn of drug risks on physicians. Drug manufacturers are immune from legal liability if they disclose the risks of their medication to physicians, who are considered "learned intermediaries." The theory behind this law is that all drugs carry certain risks depending on the circumstances in which they are prescribed. Such drugs are considered "unavoidably unsafe."

The responsibility for proper prescribing and for disclosing the risks of the medications is cast on the physician. What's unfair about this law is that drug manufacturers over-promote their products, down play or misrepresent risks, conduct and publish inaccurate or biased safety studies, and generally do not disclose all the bad information they know of about their products. Thus physicians are not in the best position to advise patients of the relative risks of a certain course of medication. Its incredibly unfair when one considers the enormous profits drug manufacturers make and the limits on their liability.

Why should a Doctor be any different than any other professional? Why do we coddle them and stand in awe in the presence of Doctors? It's because often when we see a doctor we are in a very vulnerable position, but it is precisely because of our vulnerability that we must be rational.

A Doctor is no better than a Lawyer or a Veterinarian and we should see them in that light. A Lawyer's bad advice can ruin a person financially for life. A Veterinarian's bad practice can cause our beloved innocent pet's life. If a Lawyer or Veterinarian does something that we find wrong, we have no compulsion but to announce to them loud and clear that we are not happy with their service; why not a Doctor?

I guess if you have Doctors in your family like I do, you see them as they really are, human beings like you and me. It's your life, if you are not happy with your Doctor or the service he or she provides let your Doctor know. If that doesn't help improve the situation get another Doctor who will help you. You should never look at any Doctor as the be all and end all. As in any profession, there are good Doctors and bad Doctors. It's your responsibility to find the Doctor that is good for you.

I had an interesting experience with my oncologist. He was treating me for a cancerous GIST with Gleevec, one of the new designer nucleus targeting drugs. After a few months, he warned me not to let anybody talk me into having surgery, because the medication alone should take care of the problem. But I was skeptical, because I could find nobody or no web sites that agreed with him. So I asked for copies of my medical records, and saw two other doctors. He took it personally, and dropped me as a patient!

With all due respect this is a typical lawyers answer and I totally disagree. The job of informing the patient concerning his condition and treatment is the Doctor's, it cannot be and should not be relegated to the Drug Company or anyone else. If the Drug companies "over-promote their products, down play or misrepresent risks, conduct and publish inaccurate or biased safety studies" that is a litigation issue between the medical profession and the Drug Companies as well as the governmental bodies that oversee the Drug Industry.

The statement "Thus physicians are not in the best position to advise patients of the relative risks of a certain course of medication", if it were true would be a sad commentary on the entire medical system. If not physicians, then who is in the best position, Lawyers, TV Commercials? It's just plain absurd to suggest that the Doctor cannot reasonably determine the relative risks of a drug for his patient, based on the patients history and his knowledge of the drug.

Part of a Doctors job is to read, research and familiarize himself with new drugs and if he isn't doing that then he should not be prescribing these drugs.

I don't think for a minute a doctor should be treated be any different than any other professional or non-professional for that matter. The point I am making is that doctors get conned by Big Pharma like the rest of the public. They are lead to believe drugs are safe when they are not. Massive marketing campaigns undermine the physician-patient relationship so that patients go to see their doctor asking for a particular medication because they have been taken in by the manufacturer's slick ad campaign.

Worse, doctors often allow themselves to conned by going to lavish "seminars" in lovely locations all sponsored by a drug manufacturer hyping its product. Today's USA Today notes the conflict of interest created by this practice. After a week in Hawaii at the cost of a drug company physicians are far more likely to prescribe that manufacturer's product.

RMD is correct that the job of informing the patient concerning drug risks is the Doctor's. Drug companies, however, have a responsibility to conduct proper safety and efficacy studies. All too often the quest for profit that comes with putting the latest blockbuster on the market takes precedence over disclosing known risks to the FDA, physicians, and the general public.

Accurate disclosure of known risks delays FDA approval and drives down sales. For example, Merck wrote dozens of research studies touting the safety and efficacy of Vioxx and then lined up prestigious doctors to put their names on the reports. Publishing inaccurate medical information in prestigious medical literature misleads the average physician and ultimately harms the patient.

It is indeed a sad commentary on the entire medical system that drug companies are so rich and powerful that they can mislead everyone, including doctors.

Once I overheard a good looking female drug rep, also called a "detail man", talking to my mother's doctor in his office. She explained that he would get a credit (also called a kickback in the days of the Mafia) for every prescription written after the first one. And then you have the recent penalty against Pfizer for marketing its medication for off-label applications.

I am grateful for all of the wonderful products they have developed, but their marketing practices have gotten out of control. Unfettered capitalism is as bad as pure socialism. I'm sure that the labs where the meds are developed is a whole different world than the world where they are marketed.

I've often wondered if doctors have the time and interest to research new meds on their own time. In the NJM types of publication, one of the dirty little secrets is that often there is a secret conflict of interest between the author and the manufacturer. So a prestigious publication has a lot of wonderful things to say about a drug, which is then reproduced for the marketing materials. Have you noticed the huge inserts in Time Magazine for meds?

This argument has become a cliche, but the drivers of ever-increasing profits are the expectations of the investment world of the continuing escalating successes in expanding new markets with new products, as well as the saturation of existing markets. A great example of this abuse is the release of Lovenex to replace Heparin, anti-clotting drugs.

My cardiologist told me that Lovenex is somewhat different, but not necessarily better. Heparin had become the generic standard, but it was not making any serious money for the pharm companies. So thanks to an intensive and sophisticated marketing campaign, it became increasingly difficult to even find pharmacies that had Heparin in their inventories.

And the cost difference was phenomenal. Lovenex was around $100/injection, and a 7 day supply of Heparin was going for about $10. Maybe there were situations where Lovenex was safer, but there is no justification for driving the other out of the marketplace.

To my fellow contributors, Ken K and Patrick J Filan Esq. I say Welcome to Capitalism. Money is and always will be the driving force in Capitalism. This goes for successful Drug Companies, Doctors, Lawyers etc. This is the system we have all chosen for ourselves to live under. In my 33 years on Wall Street I have seen massive amounts of money being made by many companies including Drug Companies. I have also seen massive amounts of money lost or worse stolen in the name of Capitalism and Greed.

Capitalists don't like oversight, it crimps their style and affects their ability to make increasingly larger amounts of money, Drug Companies are no exception. Did you ever wonder why drug lobbyists are so successful, think about it. The Drug companies pay them to legally bribe our law makers and we as citizens of Capitalism sit back and wonder why the Drug Companies can do whatever they want.

The Drug Companies are playing poker with us, but they already know what the cards are. The FDA is the regulatory body that is the watchdog of the Drug Industry, they are suppose to make sure Drugs are thoroughly tested and safe for the patient demographic they were intended for. Remember I said that Drug Companies don't like oversight because it affects their ability to make a lot of money. So the Drug Companies hire an army of Lawyers that are always looking for loopholes in the FDA regulations.

This is Capitalism at it's finest. To fix the problems with our health and medical system would require a complete overhaul of them and I doubt most Americans would have the stomach or the inclination for this. Americans are like the little kid who blows himself up and acts tough but on the inside he's just a frightened little kid. To a frightened little kid the Status Quo is always safer than change.

Ken K says the Drug companies "marketing practices have gotten out of control". Hot Flash, American marketing and advertising have been out of control for 40 years, remember Pet Rocks? As the Chinese say (or should say) about the American consumer, "If We Build It, They Will Buy It", this is the power of advertising in our country. When you combine the power of advertising with the Americans obsessive fascination with "being healthy" (as long as it doesn't include exercising) and living forever you can see why the Drug Companies market their products like they do. As to his statement about unfettered Capitalism, I ask, Is there any other type of Capitalism that works?

Patrick J Filan, Esq. says "It is indeed a sad commentary on the entire medical system that drug companies are so rich and powerful that they can mislead everyone, including doctors." To him I say, Wake up and smell the roses, this is Capitalism. It's every Drug company and Doctor for himself, for the rest of us it's Buyer Beware or as the Roman's said Caveat Emptor.

Over the last few years, I have been extremely impressed with the several layers of verification my favorite hospital in Dallas goes through. Before any skin is touched or violated, I am asked at least 5 times why I am a patient there and what I expect to have done. The staff doesn't tell me, I have to tell them on my own. They also scan my patient bracelet a lot to make sure that everything matches up.