Prescribing a placebo
CategoriesPlacebos are one of the "holy cows" of pharmaceutical investigation. Drug trials have to be "double-blind placebo controlled" to be of any scientific value. The placebo, formerly called a "sugar pill" is the standard (the null point) against which to measure the effect of a drug. That makes perfect sense, wouldn't you agree? Hundreds of millions of dollars are spent on trials that test the efficacy of new drugs and the relative prevalence of their side effects against a "placebo".
"What - placebos are not standardized and placebo ingredients are never disclosed?" Those were the thoughts racing through my head when I read a recent article from the Health Sciences Institute in Baltimore. Prof Beatrice Golomb explains how reticent pharmaceutical companies are about the ingredients of their "sugar pills". It seems that pharmaceutical companies routinely make their own placebo pills for each trial and even formulate them to mimic expected drug reactions.
Incredible as it may seem, this of course tends to destroy any pretense of "scientific drug testing". Could that be the reason for some of those hundreds of thousands of deaths reportedly caused by pharmaceutical drugs every year and why the medical system has become a leading cause of death in the Western world?
Aiming to Please
July 21, 2003
As a clinical research tool, a placebo is often referred to as nothing but a sugar pill - neutral and benign. In
fact, "placebo" comes from the Latin word meaning "I shall please." Everything about the word would seem to be guileless. Or that's what the general thinking is anyway.In last week's e-Alert "Seeing Red" (7/16/03) I told you about two different studies in which red clover extract was tested in the treatment of menopausal hot flashes. In both studies, the group of women who received red clover showed about the same rates of success in controlling hot flashes. But the subjects in the placebo group in one study reported almost no effect at all, while in the other study the placebo subjects had almost the same results as the red clover group.
How could the results of these two placebo groups be so different? One strong possibility: The placebos may have been very different. Because contrary to common thinking, clinical research trials - especially pharmaceutical trials - bring a whole new meaning to the old Latin idea of "I shall please."
--------------------------------------------------------------
The importance of being inert
--------------------------------------------------------------There was a time when doctors would prescribe phony medication - sugar pills - to their patients who they regarded as hypochondriacs. They called the pills "placebo" and when the patients reported positive results the idea of the placebo effect was born.
These days, placebo pills are used in clinical trials to measure the true effect of a drug or supplement. They are thought to be made of inert substances designed to have no effect. But consider this: there's no such thing really as an inert substance. For instance, placebo pills are still called sugar pills. Is sugar inert? Far from it, of course. If you take a sugar pill, your body will have a reaction, especially if you happen to have an insulin disorder. But if you're given that same pill as part of a drug research trial, your reaction becomes a factor in the research.
That may seem like nothing (what real difference could a little boost of sugar make?) but sugar and other supposedly inactive ingredients are not the issue. Not in the least.
--------------------------------------------------------------
A little secret
--------------------------------------------------------------When a pharmaceutical company tests its products, where do you suppose they get placebo pills? Do they place an order with a placebo pill manufacturer? Or does Nestle's candy company run a little side business to supply researchers with sugar pills?
The fact is, drug companies make their own placebo pills for research purposes, and for each individual study they create a unique placebo formula - sometimes purposely including ingredients that match ingredients in the drugs being tested. But at no time do the contents of the placebos have to be revealed.
Does that sound "inert" or "inactive" to you? Suddenly the idea of a "sugar pill" doesn't seem so innocent anymore.
Before conducting human trials for drugs, pharmaceutical companies are often fully aware of many of the side effects of the products they're testing. So, for instance, if a drug is known to cause dizziness and nausea, the drug company running the test wants the placebo to have the same side effects. And they have an explanation for this. They say the placebo should mimic the drug being tested so that the control group of the experiment will have side effects similar to the placebo group. Without that, they claim, the results of a blind study would be compromised.
There are plenty of gray areas to debate in that logic, but for the moment let's focus on the idea of what they call an "active placebo," designed to mimic the side effects of a tested drug. And with that in mind let's look at an advertising campaign for the allergy medication called Claritin. In the Claritin TV spots, when it comes to the moment to list the side effects, the voice-over says, "The most common side effects with Claritin, including headache, drowsiness, fatigue and dry mouth, occurred about as often as they did with a sugar pill."
A sugar pill? Really? Just what kind of "sugar pill" were the researchers using that caused headache, drowsiness, fatigue and dry mouth? Sounds to me like a sugar pill with a little something added. But they want us to believe that this medication will produce side effects no more serious than what you'd get with a TicTac.
--------------------------------------------------------------
The whistle blower
--------------------------------------------------------------Dr. Beatrice Golomb, MD, PhD, is an assistant professor of medicine at the University of California, San Diego, and has been actively fighting the research establishment's claim that placebos are inactive substances. Dr. Golomb wants scientists to provide a list of placebo ingredients so trial results can be properly evaluated.
To level the playing field, Dr. Golomb suggests that drug companies start divulging all placebo ingredients. She also recommends that a standardized set of placebos be developed that would have known and predictable side effects. This would go a long way toward eliminating the pharmaceutical industry's cynical manipulation of test data.
As you might suspect, the drug companies are not very receptive to Dr. Golomb's idea of letting go of this aspect of product testing that they have full control over.
Meanwhile, what about physicians and researchers who work independently from the pharmaceutical giants - do they know the truth about placebos supplied by drug companies? Right now it's hard to tell just how widespread this knowledge is. According to the National Center for Complementary and Alternative Medicine at the National Institutes of Health (NIH), the placebo effect is defined as "desirable physiological or psychological effects attributable to the use of inert medications." From that statement it would appear that NIH officials either believe that placebos are genuinely inactive, or they're not admitting that they know
better.Or maybe they're just feeling drowsy, dizzy, irritable and nauseous from a sugar pill someone gave them.
- - -
Related articlesPlacebo's power goes beyond the mind
Nature - letters to the editor
Pharmaceutical deaths data base
Why do pharmaceutical drugs injure
Dummy drug provides pain relief
The Scotsman: Delving into mind over matter
"On average, placebo effects cure anything between 30 to 90 per cent. That has been written up in many scientific journals. I thought, Why not see if you could extend it..."Jane Russell on the Placebo Effect
Placebos are not always inert, they can have actual ingredients ... drug companies have begun to produce "active placebos." These pills, unlike the sugar or starch pills of old, contain ingredients that mimic the common side effects of the drug under study. An active placebo might, for example, cause dry mouth if the drug to be tested was Elavil, but it probably wouldn’t cause drowsiness because Elavil is used to treat sleep disorders. It would be important to know whether people slept better with a placebo that wouldn’t have that effect. Sometimes a prescription medication is used as an active placebo. In a study published in the New England Journal of Medicine (Mar. 2005), the combination of morphine and gabapentin for relief of neuropathic pain was compared to each drug alone and to an active placebo. The placebo used was lorazepam, a benzodiazepine medication with anxiety and sedative properties, with a common effect of dizziness. Two of the most common side effects of both morphine and gabapentin are dizziness and sleepiness.Study Verifies Power of Positive Thinking
Your medicine really could work better if your doctor talks it up before handing over the prescription. Research is showing the power of expectations, that they have physical -- not just psychological -- effects on your health. Scientists can measure the resulting changes in the brain, from the release of natural painkilling chemicals to alterations in how neurons fire. It's a new spin on the so-called placebo effect -- and it begs the question of how to harness this power and thus enhance treatment benefits for patients.
 |
|
|
|
|
|
 |
|
||||
|
|
|||||
|
|
||||