Doctors are deliberately withholding information about the dangers of some routine screening and clinical procedures-often because they fear patients would then refuse treatment. Although it happens every day in surgeries and hospitals, the failure to inform is against the law and a breach of human rights legislation-which gives the patient the absolute right of autonomy over his or her body. It also leaves the doctor open to a legal challenge of negligence, assault and battery, and possibly even manslaughter if the drug or procedure goes wrong.
Effectively, any invasive procedure, including the prescribing of a drug, that is carried out without full informed consent-including careful consideration of alternatives-is an illegal act, although the doctor is so well protected by the medical establishment that proving it in a court of law is a different matter.
Despite the weight of law, true informed consent in medicine is so rare that Michael Jones, a professor of common law at Liverpool University, describes it as "a fairy story". In fact, a failure to inform is seen by the doctor as "an essential part of therapy . . . patients will worry, and become too anxious about their treatment if they are given full information".
Essentially, says Jones, doctors run roughshod over a patient's right to know because they believe:
- the patient will worry, and become too anxious if given full information
- the patient will not understand the information in any event, because it is too complex and technical
- the patient would become too confused by the information, and make the wrong decision (in other words, that which the doctor isn't advising)
- doctors just don't have the time to give out all this information
- patients actually don't want the information-it is a burden they shouldn't have to bear (Med Law Rev, 1999; 7: 103-34).
The patient is an unwitting participant in this dance of disinformation. According to a survey by the Consumers Association, one in four patients say they were given no information unless they asked; even those who did ask some questions, 14 per cent didn't ask all the questions they wanted to. Of those who didn't ask any questions, 63 per cent assumed they would be told everything they needed to know at some point. Others said they lacked the confidence to ask, or the specialist seemed disinterested in them and their condition, while the rest wanted "to keep on good terms with the specialist".
What they don't tell you
Every drug, surgical procedure and diagnostic tool carries with it a risk that, as the General Medical Council reminds doctors, can range from "common but minor side-effects, to rare but serious adverse outcomes possibly resulting in permanent disability or death".
For example, one computed tomography (CT) scan causes cancer in one out of every 270 people screened, but patients are never told this nor even asked for their consent before they are exposed to cumulative radiation levels similar to those at Nagasaki and Hiroshima after the atomic bomb was dropped. One study discovered that some patients have had 70 CT scans over eight years, which is equivalent to the radiation levels from 21 Hiroshimas-and yet the patient was never told about these enormous risks (AJR Am J Roentgenol, 2009; 192: 887-92).
As H.E. Davies, from the University Hospital of Wales, put it, "an awareness of the radiation risk and knowledge of alternative options might affect the patient's decision and alter the course of their management" (BMJ, 2012; 342: d947). In other words, if patients were told the true dangers, they would refuse treatment.
Doctors fear the same might happen if they reveal to patients that 5.7 per cent will die after surgery for ulcerative colitis. As researchers from the University Hospitals Bristol NHS Foundation Trust asked, after discovering such a high mortality rate: "What should we tell our patients?" (Frontline Gastroenterol, 2010; 1: 35-41). Researchers asked the same vexing question after they discovered that one in 10,000 patients dies from fatal pulmonary embolism following varicose vein surgery (Phlebology, 2005; 20: 175-8).
Routine biopsies fare only slightly better. According to one review from the Royal London Hospital, just 6 per cent of biopsies where tissue samples are retained had been consented to by the patient (BioCentre, 2008; ). This lack of consent is illegal, and falls foul of the Human Tissue Act, 2004, which requires "explicit" consent before any tissue samples can be retained. The legislation was a response to the Alder Hey scandal. In 1999, it was discovered that doctors at the Alder Hey Children's Hospital in Liverpool
had been removing and retaining organs from dead children, often against the wishes of the parents.
Even after the Vioxx drug scandal had become public-eventually, the manufacturer agreed to pay out $4.85 billion to the families of around 50,000 people who died while taking the painkiller-doctors were still asking, "What should we tell our patients?" (J Chiropr Med, 2004; 3: 160-3). As one exasperated doctor put it, "Do they really expect us to read out the PDR to them?" (The 'PDR'-Physicians' Desk Reference-is a 2000-page tome that lists every known side-effect to prescription drugs in the US.)
Often, the risks are slight, but still very real. Patients are rarely told the real dangers of routine bronchoscopy, where a tube is threaded down the nose to observe the major airways to the lungs, which results in a death with every 2500 procedures. Nor are patients informed that they run the risk of suffering a serious eye infection, called 'infective endophthalmitis', when they have a cataract operation. The risk may be small-it happens to around two out of every 1000 people who undergo surgery-but it is nonetheless a very real possibility, and one that should be revealed. As Lord Bingham said in a landmark House of Lords ruling in 2004, ". . . medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well-established, risk of serious injury."
This has been the legal position for 60 years following the case of a patient who was left partially paralyzed following an aortogram, an X-ray using dyes. Paralysis is a known, but slight, risk with the procedure, but the radiologist had failed to tell the patient. In summing up, the judge said, "a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of intelligent consent by the patient".
The patient's position in the UK was strengthened further with the Human Rights Act of 1998, which gives the individual the right:
- to life (article 2)
- to be free from inhuman or degrading treatment (article 3)
- to respect for privacy and family life (article 8)
- to freedom of expression, which includes the right to hold opinions and to receive information (article 10).
What is informed consent?
Despite these clear legal guidelines, doctors are rarely charged with negligence or incompetence purely on the grounds of a lack of informed consent. This is because they can often point to some 'proof' that the patient had given his or her permission before the procedure began or the drug had been prescribed. Consent can range from its inference when a patient opens his mouth on the doctor's command to 'open wide' or walks off with a prescription to the signing of a consent form if any invasive procedure is required.
The consent has to be informed and voluntary, however. Sir Ian Kennedy, a lawyer and vice-president of the UK's College of Medicine, says that a consent form signed by a patient not properly informed is meaningless. "It's an established legal principle that if there's been no explanation of what's involved, the signature doesn't mean anything," he said. Conversely, oral consent given by a fully informed patient is legal. A patient who has signed because he or she feels coerced or bullied by the medical staff has not done so voluntarily, and this also is illegal and leaves the doctor open to action if the procedure goes wrong.
Written consent is always required for any medical procedure, although medical staff see it as being nothing more than an irritating, but necessary, bureaucratic duty usually performed by a junior doctor-and it seems the patient has a similar view.
One study discovered that more than half the women monitored signed the consent form within 30 seconds of being handed it, suggesting that they had skim-read it at best (J Empir Res Hum Res Ethics, 2008; 3: 89-97).
In a study of patients who gave their consent prior to surgery, 44 per cent either did not understand, or had an 'unsatisfactory' understanding of, what they were signing (Kathmandu Univ Med J [KUMJ], 2005; 3: 271-3). In another study, just 29 per cent were considered to have given truly informed consent prior to surgery (Am J Surg, 2009; 198: 420-35).
The situation is not much better when patients are recruited into clinical trials to test the effectiveness of drugs. In a survey of 80 people who were participating in various trials, 25 per cent said they were taking part because their doctor had asked them to. Half did not fully understand what informed consent meant, and 32.9 per cent had not even read the consent form, although they had signed it (Arq Bras Cardiol, 2010; 94: 4-9).
This is a long way from truly informed consent as defined by the UK's Department of Health. To them, informed consent means giving the patient enough information to make a considered decision, and that will include answers to questions such as:
- What sort of things will the treatment involve?
- What are the benefits they hope will result?
- How good are the chances of getting such benefits?
- Are there any alternatives?
- What are the risks, if any?
- If there are risks, are they minor or serious?
- What may happen if you don't have the treatment?
In its own guidance notes to doctors, the General Medical Council (GMC) is far less exacting. It believes it is sufficient to tell the patient about any risks with the procedure, such as side-effects, complications or what might happen if it doesn't work (Consent: patients and doctors making decisions together. General Medical Council, 2008). However, the GMC's latest position is criticized by law experts, who say it is less demanding than its previous guidelines, and is not even keeping pace with common law, which recognizes patient autonomy and informed decision-making (J Med Ethics, 2010; 36: 494-7).
By comparison, the GMC's US equivalent, the American Medical Association (AMA), has far more demanding criteria for informed consent. It expects the doctor to explain:
- the diagnosis, if known
- the nature and purpose of any proposed treatment or procedure
- the risks and benefits of the proposed treatment
- alternatives, regardless of cost
- the risks and benefits of the alternatives
- the risks and benefits of not undergoing any treatment.
However, alternatives-as defined by the AMA and the UK's Department of Health-are restricted to other treatments that "an informed body of professionals would think appropriate". Don't expect the doctor to recommend homeopathy as a reasonable alternative.
Even 'alternative' advice on diet and nutrition may be a stretch too far for the doctor. Medical students in the US receive around 19 hours of education about nutrition during their five-year medical training. The students themselves believe they have received inadequate training, and are not able to give patients good nutritional advice (Acad Med, 2010; 85: 1537-42).
The doctor knows little
Informed consent infers that the doctor is informed. 'Medical paternalism', as Lord Bingham described it, requires the doctor to be all-knowing, and that he understands every possible risk, side-effect and adverse reaction to a treatment or drug.
Not only is this far from the truth, it is also untrue even for specialists and their narrow area of expertise. A survey of radiologists discovered that only 47 per cent of them knew that CT scans could cause cancer-and only 9 per cent of general physicians were aware of the risk (Arch Intern Med, 2009; 169: 2071-7).
And oncologists, or cancer specialists, seem to be confused by what DCIS (ductal carcinoma in situ) actually is. Although DCIS is a non-invasive, precancerous condition that, in at least 80 per cent of cases, never develops into breast cancer, oncologists do not always understand the implications of the diagnosis. Some recognize that it is precancerous, but others believe it is cancer and some will even perform a full mastectomy, or total breast removal. A survey of 45 women found that they were also "confused" by the conflicting and contradictory advice they were given. One woman reported her surgeon's surprise at her worries when she didn't even have cancer. She told him: "Well, if I haven't got cancer, why am I having radiotherapy and why have you taken a 9-cm by 6-cm by 3-cm chunk out of my breast?" (J Adv Nurs, 2012; 68: 856-67).
The patient knows nothing
Why do doctors get away with flouting informed consent legislation? Because the patient lets them. The patient does not know either the legal rights or powers he or she has, or still labours under the misapprehension that the doctor knows best, or is perhaps overawed or feels bullied by the doctor.
None of these reasons is adequate when the patient is about to take a drug or start a therapy that potentially can harm, maim or even kill.
In the US, doctors are much more conscious of obtaining proper informed consent because they work in an environment where patients' rights are paramount, and they realize that there could be a serious comeback if the patient sues. While few would wish to see the UK become equally litigious, British doctors are allowed to get away with far too much.
Far from being a dry legal point, true informed consent is at the heart of medicine, and could one day even lead to its decline if doctors followed it properly-because once patients know the true risk, who would want the treatment?
Factfile: Prescription drugs and informed consent
The writing out of a prescription for a pharmaceutical is the most common and routine 'intervention' that a doctor performs. It's a practice that is also covered by informed-consent legislation, although you'd never guess from the meagre amount of information the doctor usually tells the patient about any drug.
Despite this disregard for patients' rights, doctors almost never are taken to account if the patient suffers an adverse drug reaction. This is due to a number of factors:
- the doctor may assume the drug is safe to prescribe because it has passed through all the regulatory controls
- any adverse reaction-even death-is the responsibility of the pharmaceutical company, not the doctor
- the patient can also get more information about a drug from the pharmacist preparing the prescription
- package inserts act as an important part of informed consent.
Doctors are also becoming increasingly reliant on drug company salespeople once they have left medical school.
One study into the sale of Neurontin (gabapentin), an antiepileptic, discovered that 40 per cent of sales representatives' visits involved the 'off-label' use of the drug as a painkiller and for migraine.
Such 'off-label' use-where a drug is used to treat conditions for which it has not been tested-is not approved by drugs regulators and, yet, is a common practice.
All 97 doctors featured in the study agreed to increase their use of the drug, both for the treatment of epilepsy and for 'off-label' conditions (PLoS Med, 2007; 4: e150).
Factfile: Prescription drugs: Questions you need to ask
Most people who come off worse from an encounter with medicine suffer an adverse reaction to a drug, so it's very important that you
give proper informed consent before starting such treatment. Here are some of the questions to which you need full answers.
- How long has the drug been on the market? (If less than two years, ask for an older-generation drug that can also help your condition).
- Can you confirm that I am not taking part in a drug trial?
- Is the drug suitable for my age/gender/condition?
- Are you using this drug 'off-label' or for the condition for which it was originally licensed?
- Are there any special warnings or 'black-box' alerts for this drug?
- Can you please explain to me the known side-effects and the likelihood of me suffering them?
- Has the drug been tested among people similar to my own age/gender?
- Do you know if the drug has been banned from use in other countries?
- Have you given this drug to other patients? If so, have they reported any adverse reactions or side-effects?
- Is the dose you are recommending within the guidelines of the manufacturer for my age/gender/condition?
- Do you know if the new drug will react with other drugs I am currently taking?
- If I start to suffer from health problems when I take the drug, I shall stop immediately, and come and see you again. Do you agree this is the best course of action?
Factfile: True informed consent
There are questions you must ask before agreeing to any medical procedure or treatment. Only when you have complete answers that entirely satisfy you can you say that you can give your true informed consent-or reject the treatment.
- Are you sure the diagnosis is correct?
- What is the treatment you propose, and what do you hope to achieve with it?
- What are the chances that you will achieve this benefit (and try to get an answer that is less nebulous than 'very good')?
- What are the risks associated with the procedure-and please tell me all the risks, no matter how slight?
- Does my age/gender/condition increase the chances of a poor outcome?
- Are there alternatives of which you are aware that could also be considered?
- If so, what are the benefits and risks of those?
- Are you qualified to tell me about any dietary/nutritional or alternative/complementary approaches? If not, may I speak to someone who is?
- What might happen to me if I refuse treatment?
- How many times have you/the surgeon performed the procedure?
- Has the procedure always been carried out successfully? If not, how many times has it gone wrong and what has gone wrong?
- Can you confirm that I am not taking part in a clinical trial?