Dementia drugs and the folly of false promises: How doctor-prescribed placebo is destroying Medicare and harming patients
August 7, 2016
An interesting and revealing incident occurred regarding one my patient’s medicines for dementia. I am not an advocate for using medicines for dementia, as I will delineate below, and as I have explained in my book and in previous blogs. Despite how well marketed and utilized these medicines are, despite how deeply patients/families/doctors truly believe that these medicines alone or in combination are necessary weapons to combat the terrible mind-decaying disease, I have no such faith. My skepticism eminates from my own long experience, from my knowledge of how these drugs work, and from scientific reality. In fact, a recent study suggests that primary care geriatric doctors like me are much less likely to prescribe dementia drugs than specialists like neurologists and psychiatrists.
Thus, I often try to convince my patients’ families to withdraw these drugs, especially after a year of use when their utility has absolutely no basis of scientific credibility, but also when dementia becomes severe and the drugs are clearly useless, when side effects of the medicines may be occurring (such as weight loss and nausea), and when we simply want to alleviate some of a patient’s medicine burden. Many families, especially those who continue to see neurologists, resist. They want to believe, or actually do believe, that their mom is doing better on drugs like Exelon and Aricept and Namenda, and that much more rapid mental decline is inevitable if the drugs are withdrawn. Some who have tried to withdraw drugs immediately reverse course, sensing changes in mom that frighten them, worrying (as many pharmaceutical salesmen and neurologists purport to be true) that mom will never again regain the mental improvement that she had on these wonder drugs even after a brief time off of them. These drugs are a crutch worshipped by families looking for some modicum of hope amidst the overwhelming darkness and helplessness of dementia.
Recently one of my patient’s sons was happy to discuss medicine reduction for his mom. His mom was a very pleasant woman in an assisted living facility whose progressive dementia left her more dependent on care, less sharp in her thinking, but still happy and interactive. She had been on Namenda for years, something her former neurologist had proclaimed would slow the disease’s progression, and it was costing the son a lot of money. “Is it worth it?” the son asked me. I did not think so, and I quoted him a few studies. So he asked to stop it.
His mom continued her mental decline over the next two months. Some of the nursing aides believed her confusion to have accelerated a bit, if such things can really be measured. She was more forgetful and less mentally nimble. Her son felt the same way; mom was certainly getting worse much more quickly since stopping Namenda. I saw her last week, and to me she seemed about the same, but of course there is always doubt that enters our minds. Was the Namenda actually helping her? Was it just coincidence that her more rapid decline occurred at the time of the drug’s cessation?
“Maybe we should start her back on the Namenda,” the son suggested. I could tell he believed that we had made a grave error. I told him we could try.
I found her nurse, who too was a skeptic about these drugs after too many years of watching them do nothing useful for her patients, and asked her if she sensed a decline. She said yes, of course, that’s what happens in dementia. “Well maybe we should start back on the Namenda,” I suggested. The nurse looked at me and smiled. “Don’t you remember?” she said. “Her son wanted to finish her supply of Namenda before stopping it. She is still taking the Namenda; she’ll run out next week.”
Such is the power of blind faith, of placebo. The theater at the start of this article shows the impact of placebo on dementia: in most dementia studies, 300 people out of 1000 have measurable improvement in dementia test scores with placebo. While many doctors and pharmaceuticals quote a 40-50% improvement in mentation among those people who take Alzheimer’s drugs like Aricept and Namenda, they are leaving out three important points. First, the improvement is very tiny, measured on a 40 point test, and rarely recognized by care givers when compared to placebo. Second, the duration of improvement is brief, usually lasting 4-6 months before gravitating toward placebo; by a year, patients on drug and on placebo score similarly on memory tests. Third, and most remarkably, the impact of taking placebo is far greater than the impact of the drug. In fact, as the theater shows, 30% of people who take placebo actually improve on the mental status test, and an additional 9% improve with the drugs. Most of those 9% have a tiny improvement that vanishes within a year, when virtually every study on these drugs ends. Care giver scores of improvement between drug and placebo are even smaller, approaching zero in most studies. And drugs like Namenda have even smaller improvement, while drugs in combination are no better than drugs on their own. When I reviewed the literature available about Namenda, including what was compiled by the prestigious Cochrane group, I found that most studies were very tiny and heavily screened, that they lasted no more than 6 months, that their criteria for success was both variable and small (just two to four point improvement often on a 40 or 100 point memory test implied drug success), and the results were completely inconsistent, with some studies showing mild improvement for some with advanced dementia, to some showing no real improvement at all; none showed improvement in mild to moderate dementia. Looking at the literature one has to assume that most of the improvement derived by taking dementia medicine, especially for prolonged duration, is directly related to the placebo effect.
Thus when we withdraw these drugs and families and doctors and others sense that mom is getting worse, they are seeing the impact of taking away a placebo, not any meaningful effect of the drug itself. As with the case above, when the son thought his mom was off a drug that in fact she was still taking, he convinced himself that mom had become much worse at the point that the drug was stopped. Placebo is powerful in its persuasive capacity. It is a major reason that so many people believe that drugs and tests and procedures are beneficial. A recent article suggested that a surgical procedure to ameliorate atrial fibrillation may be no more successful than a sham (placebo) procedure that claimed to be doing the same thing. How many times do doctors “fix” a patient’s arteries, clean out carotids, give a shot of vitamin B12, surgically repair a slipped disk or torn cartilage, put them on a drug that is supposed to help “cure” a problem, and suddenly their symptoms dissipate? How often would the same result occur with a placebo or by doing nothing, at a far lower cost and with much less risk?
We know that medical interventions have very little benefit in the vast majority of cases, and yet we keep pursing them as though they are curing us of illness. A recent New York Times article shows how several popular surgical procedures that have been shown not to work are still widely used by doctors (who are generously paid by Medicare for their useless work) and are felt by patients and doctors to be effective, despite evidence to the contrary. We feel the desperate need to think we can fix the ravages of aging as long as we assault disease with all the guns and weapons at our disposal, even if those weapons are firing blanks. The unfortunate reality, that I discuss in detail in my book, is that often such an approach causes significant harm to our patients without fixing anything. And yet we continue to have faith in these cures, buttressed by an equally devout passion by our doctors and by everything we read on the front page of the newspapers. To convince Medicare not to pay for ineffective therapy would garner a severe backlash from patients and doctors who want to believe that miracles are possible to cure the ravages of aging.
One has to wonder why doctors continue to be so culpable in pushing interventions that scientific fact has shown to be of dubious value. Why do neurologists convince patients that one or more of these dementia drugs will accomplish feats that their reading of the evidence and their own observation should certainly dispute? Do they really believe that piling drugs into such patients’ vulnerable bodies will revere a disease that currently knows no cures? Or are they, like the son of the dementia patient who has brought mom to them, simply desperate to do something, to hope for a miracle, to convince themselves that with enough faith in the medical establishment they can cure a horrible disease? In my experience, and in studies that look at population health, specialist-dominated care precipitates an excess of unnecessary medical interventions, leading to far higher cost of care with much worse outcomes. And yet that is what patients crave: false hope, expensive placebos.
Such magical thinking makes it very difficult for those of us who see the world rationally, and who do not profit from over-treatment, to convince our patients that aggressive medical care often leads people down a very dangerous and delusional road, often dissuading them from accepting and accommodating to disease in a way that would be much more helpful than is swallowing a pile of medicines, and often leading to adverse effects and interactions. Somehow, either in medical school or throughout their careers, the medical community has lost its ability to interpret data and to accurately explain risks and benefits of interventions to their patients. They have rather leaped on the train of blind faith that suggests the need to test and treat excessively, convincing patients of their power to heal disease even when such contentions are at best false and at worse harmful. And what is worse, the more interventions specialist doctors push, the better they get paid and the more they are respected; such is the central flaw of our health care system. The delusion of dementia treatment, which keeps so many of my patients going back to see their neurologists for no beneficial reason, provides a placebo to my patients and an infusion of cash to the specialist. No one in Medicare will dare stand in the way.
What can be done about this? How do we persuade patients and doctors that dementia has no cure, that drugs are often harmful, and that there are better ways to confront the disease than to try to “fix” it? How do we convince doctors to stop pushing an agenda on their patients that enriches them financially and covers them in a veil of being caring and thorough healers who are going to help mom get better when such a proclamation has no basis of fact? To me, doctors who prescribe these drugs must be responsible for showing patients the actual data in a format the patient can understand. For Namenda, if we built a 1000 seat theater that compared the effect of Namenda to placebo, we may show 2 theaters. One would fill in 300 seats to shows the impact of placebo, which is at the top of this blog. The other would have a question mark on it to demonstrate that we do not know if the drug has any benefit. As an explanation we may state what we know about Namenda: that a small number of people with severe dementia may improve to a limited extent for up to 6 months. Beyond that, everything is conjecture and hyperbole. The over-treated, over-priced medical society in which we live and work would be better served if doctors actually told their patients the truth. It is time doctors are paid more for doing that, and paid less for dispensing dangerous placebos.