The Informed Consent Charade: Are Patients Truly Protected?

Before any surgery or medical treatment, patients are asked to agree to what is known as informed consent. What does that mean? Health care providers have both a legal and an ethical responsibility to ensure that every patient has adequate information to make a knowledgeable decision. Patients are supposed to have a clear and accurate understanding of the risks, benefits and alternatives before agreeing to proceed.

No patient should undergo surgery, or accept a prescription, without truly knowing what is involved and the possible consequences. In practice, though, that protection may be more illusion than reality. At many medical institutions, obtaining informed consent may be treated as a pesky bureaucratic hoop to be hurdled rather than a real opportunity to protect the patient.

And when it comes to medications, very few prescribers reveal the actual effectiveness of the medicine they are recommending. Rarely are patients told how likely they are to experience adverse reactions.

Studying Informed Consent Forms

Researchers analyzed more than 100 procedure consent forms from high volume hospitals (JAMA Internal Medicine, Dec. 11, 2023).

• Most forms were written in complex language
• Risks were inconsistently disclosed
• Likelihood of success was often unclear
• Hospitals serving vulnerable populations were less likely to discuss alternatives or the option of declining treatment

In other words, many patients may sign forms they do not fully understand because they feel rushed or ashamed to ask difficult questions.

When Informed Consent Becomes a Formality

It has been our experience that consent forms are often presented at the worst possible moment.

Picture this:

• You’re already in a flimsy hospital gown tied in back. You may be anxious. You might not even have your glasses.
• An IV is in your arm. Perhaps you’ve received medication to calm your nerves.
• Someone hands you a multi-page document or an electronic tablet filled with technical jargon and asks for your signature. There’s even a name for such a device: eIC (Electronic Informed Consent) Tablet.

Few people feel comfortable slowing things down to ask questions at this point. There is often an unspoken pressure to move things along, as if hesitation might disrupt the entire surgical schedule. Do you really want to inconvenience your surgeon, the nurses, the whole operating team? No one wants to do that! Alienating your surgeon just before you are wheeled into the OR seems like a very bad idea.

Under such circumstances, is consent truly voluntary?

What Patients May Not Realize

What’s buried in that paperwork or electronic form? Hopefully, the surgeon already told you about the major risks of surgery before the day of the procedure, but perhaps not everything.

Included in the “consent” forms may be:

• Permission for a resident or trainee to perform the procedure
• Lack of discussion about alternative treatments
• Little or no explanation of what happens if you decline or there’s an emergency
• Minimal clarity about less common but serious risks
• Post-operative pain management

Experts are clear on this point: “It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree with the provider.”

Informed Consent and Medications

The informed consent problem is not limited to surgery.

Patients are rarely asked to sign formal consent forms before starting medications, but the ethical obligation is the same. Prescribers should clearly explain both benefits and risks.

When I wrote the first edition of The People’s Pharmacy more than 50 years ago (St. Martin’s Press, 1976) I discovered an editorial in the pages of the Journal of the American Medical Association (JAMA Jan. 26, 1970). It was titled:

“Inform the Patient”

“When a physician prescribes a drug, he has an obligation to warn the patient about the drug’s potential for causing adverse reactions, especially the more serious ones.”

“The duty to inform extends to the physician’s helpers. An example of an amazing dereliction appeared in a letter to the editor of the New England Journal of Medicine and is reprinted here in case JAMA readers missed it. It is a true incident-accident report that read in part as follows:

“To: Chief, Nursing Service

“Name of individual Involved: Smith, John

“Mr. Smith on 14 April 66 was given some liq pHisoHex soap so he could take a shower before going (sic) to surgery instead of taking a shower c pHisoHex he drank it. Because he didn’t go to surgery on 14 April Mr. Smith was given some more liq pHisoHex so he could take a shower before going to surgery, but instead he drank it again. There was another person with Mr. Smith this AM when the aide gave him the pHisoHex and heard me tell him to take a shower c the pHisoHex soap. This AM the patient complained that the medicine made him vomit to the doctor.”

The lesson is as relevant today as it was then: Communication failures in medicine can have serious consequences.

Details…Details…Details!

It’s not good enough to have a healthcare professional say that drug X is being prescribed to lower cholesterol, or relieve depression or control hypertension. The prescriber has an obligation to tell the patient how effective it may be. How well will it work to prevent a heart attack or remove symptoms of sadness? And I do not mean generally…I mean specifically based on the medical literature!

I have frequently cited an old Lipitor (atorvastatin) ad that ran in popular magazines a few decades ago.

Pfizer stated:

“In patients with multiple risk factors for heart disease,

“Lipitor reduces risk of heart attack by 36%*

“If you have risk factors such as family history, high blood pressure, age, low HDL (‘good’ cholesterol) or smoking

*  “That means in a large clinical study 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients of patients taking Lipitor.”

So, should a prescriber say that atorvastatin can lower the risk of a heart attack by 36% after 5 years or that atorvastatin can reduce the risk of having a heart attack in 1 person out of 100 after 5 years? In my opinion, the absolute risk reduction of 1% is a more accurate representation of the benefit. I am not sure many prescribers would share that kind of information with their patient.

What About Side Effect Information?

When it comes to side effects, how many times have you been told the likelihood you might experience an adverse drug reaction? Medications must go through rigorous randomized controlled trials before they can be approved by the FDA. The data that were collected are provided in the official prescribing information.

If you go to DailyMed, you can look up the adverse reaction data for yourself. For example, the weight loss drug Zepbound (tirzepatide) lists the following details for the 10 mg injection. The percentages are the number of people who reported the following symptoms:

• Nausea               29%
• Diarrhea            21%
• Vomiting            11%
• Constipation     14%
• Indigestion         9% 

That kind of information gives a potential patient more information than “common” side effects or “rare” side effects. Physicians, nurses and pharmacists should provide details that allow patients to make informed decisions.

Why Informed Consent Matters!

One of the most challenging medical decisions a patient or family must make is whether to go to the emergency department. Which adverse drug reactions are serious enough to merit a call to the doctor or a visit to the ER?

Jenny shared this story about her husband’s experience with the blood pressure drug lisinopril. He had not been warned about this potential adverse reaction:

“My husband was on lisinopril for about seven years when he developed a bad reaction. In hindsight, we didn’t realize the signs leading up to his event. He was always coughing, blowing his nose, and I found out later that he was vomiting daily but he thought it was just from post-nasal drip from whatever allergy he thought he had.

“A few months before the big reaction, his upper lip swelled up, and he went to a walk-in clinic. He was given steroids and prescribed an Epi Pen in case it ever happened again. The doctor there had no idea what caused my husband’s reaction.

“Fast-forward a few months, and one night I was in the living room watching tv. He came out holding his throat and handing me his Epi Pen. His neck was huge, and he couldn’t talk. I used the Epi Pen on him and called 911. By the time we got to the ER he was in full code. The ER surgeon finally got a trach tube in, thank goodness, but he was on a ventilator and sedated for a week.

“He couldn’t write or anything when he awoke. He acted compulsive for weeks, and to this day he’s just a little different than before the reaction. The doctors said it was angioedema due to lisinopril. It was horrible, and I’m so happy he’s alive.”

Angioedema can be a life-threatening reaction, as should be clear from Jenny’s description. Anyone who gets a blood pressure medicine with “pril” in the name (benazepril, captopril, enalapril,  lisinopril, ramipril, etc) should be warned about the symptoms of angioedema. This condition can hit the lips, mouth, tongue and throat and make breathing difficult. If angioedema strikes the digestive tract, it can cause severe abdominal distress.

Final Words

What Better Informed Consent Should Look Like

The Hippocratic oath is broadly understood to forbid doctors from doing harm. But nearly all treatments carry some risks, and patients deserve to know what they are before agreeing to be treated.

Informed consent discussions should happen well before the day of a procedure, not in the final anxious minutes before surgery. Consent forms should be written in plain language that a person without a medical degree can actually understand. Patients should be explicitly told they have the right to ask questions, request alternatives, and say no.

We’d like to see these forms provided, reviewed, and discussed in a calm setting, not thrust at a patient with an IV in the arm and a surgeon waiting down the hall. If a resident is going to do much, if not all, of the procedure, the surgeon in charge should introduce that doctor-in-training to the patient and be very honest about the oversight. The patient should be advised of this possibility well before surgery.

Our Advice

Until procedures change, here is our practical advice: if you have surgery scheduled, ask for the consent form in advance. Read it when you are calm, at home, with your glasses on. Write down your questions. And remember, you are always allowed to ask, “Who exactly will be performing this surgery?“

Did you find this information helpful? If so, please share it with friends and family. If you have ever had to sign an informed consent form, please share your experience in the comment section below.

Have you ever received a prescription? Were you told in detail how effective it would be for resolving your health problem? Did the prescriber tell you the percentage of people who might avoid a heart attack, stroke or some other serious complication after taking the medicine for years? Were you told the number needed to treat (NNT)? How many people would need to take this medicine for one to get a benefit?

What about side effects? Have you been told the most common and/or most dangerous adverse drug reactions associated with your medicine? Were you given details, such as 29% of the people taking this medicine experienced nausea in the clinical trials? We would love to know whether you have been given accurate information before receiving a new prescription. Thank you for sharing your experience and supporting our work.