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News & Views
Drug Trials: The Hidden Truth About Placebo Testing
Date: 09/02/05
Keywords:
There was a time when doctors sometimes prescribed phoney medication to their patients who they regarded as hypochondriacs. They called the pills placebo (a Latin word meaning I shall please), and when the patients reported positive results the concept of the placebo effect was born...After more than four decades of testing in tandem with other drugs, placebo recently gained approval for prescription use from the US Food and Drug Administration.
Most people would never think to question the contents of a placebo. After all, everyone knows that placebos have no active ingredients. But if a placebo could talk, it would respond just like any con man caught with his hand in your pocket: Who ME? Would I lie to you?
Sugar coating
There was a time when doctors sometimes prescribed phoney medication to their patients who they regarded as hypochondriacs. They called the pills placebo (a Latin word meaning I shall please), and when the patients reported positive results the concept 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 commonly called sugar pills. But 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 tiny boost of sugar make?), but a little sugar is not the issue here. Far from it.
A little secret
When a pharmaceutical company tests a product in a placebo-controlled trial, where do you suppose they get placebo pills? Do they place an order with a placebo pill manufacturer? Or does Nestls sweet company run a side business that supplies 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 including ingredients that match ingredients in the drugs being tested. But the contents of placebos are never revealed.
Does that sound inert or inactive to you? Suddenly the idea of a sugar pill doesnt 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 may want 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 grey areas to debate in that logic, but for the moment lets 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 lets look at a US advertising campaign for a popular allergy medication. In the TV advertisements, when the moment arrives to list the side effects, the voice-over says, The most common side effects - 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 youd get with a TicTac.
Inertia standardised
Dr. Beatrice Golomb, PhD, is an assistant professor of medicine at the University of California in the US, and has been actively fighting the research establishments 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 standardised placebos should be developed so that side effects will be uniform and predictable. This would go a long way toward eliminating the pharmaceutical industrys cynical manipulation of test data.
As you might suspect, the drug companies are not very receptive to Dr. Golombs 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 its hard to tell just how widespread this knowledge is.
According to the US National Centre 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 the NIH either believes that placebos are genuinely inactive, or theyre not saying.
Or maybe theyre just feeling drowsy, dizzy, irritable and nauseous from a sugar pill someone gave them.
. . and another thing
Could you use a little spice in your life?
A US Department of Agriculture study measured the phenolic content and antioxidant activity of 27 culinary herbs and 12 medicinal herbs under laboratory conditions. The medicinal herbs faired well; familiar names like periwinkle, gingko biloba, garden sage, St. Johns Wort, valerian, and sweet Annie all showed significant antioxidant content.
But the fresh culinary herbs blew them away. And guess which was the leader of the pack? Plain old oregano.
Oregano was found to have 42 times more antioxidants than apples, 30 times more than potatoes, 12 times more than oranges, and 4 times more than blueberries! That means that one tablespoon of fresh oregano has the same free-radical fighting power as one medium-sized apple.
Overall, oregano had 3 to 20 times more antioxidant content than the other herbs tested. Dill, thyme, rosemary, and peppermint all ranked fairly high. But the dried herbs didnt quite cut it. According to the studys authors, fresh herbs are the best choice, as some of the antioxidant concentration is lost in processing.
Most grocery stores now carry a wide variety of fresh herbs, and its easy to work them into familiar recipes. As a general rule, if a recipe calls for one teaspoon of a dried herb, you can substitute one tablespoon of chopped fresh herb in its place for the same taste. Fresh herbs should stay good in your refrigerator for up to five days if stored properly; cooking experts recommend wrapping them in a damp paper towel and sealing them in an airtight plastic bag.
Of course, you still need to eat your fruits and veggies; these foods offer a wide range of other beneficial phytochemicals, plus vitamins, minerals, and fibre that are essential to good health.
Back to topMost people would never think to question the contents of a placebo. After all, everyone knows that placebos have no active ingredients. But if a placebo could talk, it would respond just like any con man caught with his hand in your pocket: Who ME? Would I lie to you?
Sugar coating
There was a time when doctors sometimes prescribed phoney medication to their patients who they regarded as hypochondriacs. They called the pills placebo (a Latin word meaning I shall please), and when the patients reported positive results the concept 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 commonly called sugar pills. But 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 tiny boost of sugar make?), but a little sugar is not the issue here. Far from it.
A little secret
When a pharmaceutical company tests a product in a placebo-controlled trial, where do you suppose they get placebo pills? Do they place an order with a placebo pill manufacturer? Or does Nestls sweet company run a side business that supplies 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 including ingredients that match ingredients in the drugs being tested. But the contents of placebos are never revealed.
Does that sound inert or inactive to you? Suddenly the idea of a sugar pill doesnt 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 may want 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 grey areas to debate in that logic, but for the moment lets 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 lets look at a US advertising campaign for a popular allergy medication. In the TV advertisements, when the moment arrives to list the side effects, the voice-over says, The most common side effects - 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 youd get with a TicTac.
Inertia standardised
Dr. Beatrice Golomb, PhD, is an assistant professor of medicine at the University of California in the US, and has been actively fighting the research establishments 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 standardised placebos should be developed so that side effects will be uniform and predictable. This would go a long way toward eliminating the pharmaceutical industrys cynical manipulation of test data.
As you might suspect, the drug companies are not very receptive to Dr. Golombs 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 its hard to tell just how widespread this knowledge is.
According to the US National Centre 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 the NIH either believes that placebos are genuinely inactive, or theyre not saying.
Or maybe theyre just feeling drowsy, dizzy, irritable and nauseous from a sugar pill someone gave them.
. . and another thing
Could you use a little spice in your life?
A US Department of Agriculture study measured the phenolic content and antioxidant activity of 27 culinary herbs and 12 medicinal herbs under laboratory conditions. The medicinal herbs faired well; familiar names like periwinkle, gingko biloba, garden sage, St. Johns Wort, valerian, and sweet Annie all showed significant antioxidant content.
But the fresh culinary herbs blew them away. And guess which was the leader of the pack? Plain old oregano.
Oregano was found to have 42 times more antioxidants than apples, 30 times more than potatoes, 12 times more than oranges, and 4 times more than blueberries! That means that one tablespoon of fresh oregano has the same free-radical fighting power as one medium-sized apple.
Overall, oregano had 3 to 20 times more antioxidant content than the other herbs tested. Dill, thyme, rosemary, and peppermint all ranked fairly high. But the dried herbs didnt quite cut it. According to the studys authors, fresh herbs are the best choice, as some of the antioxidant concentration is lost in processing.
Most grocery stores now carry a wide variety of fresh herbs, and its easy to work them into familiar recipes. As a general rule, if a recipe calls for one teaspoon of a dried herb, you can substitute one tablespoon of chopped fresh herb in its place for the same taste. Fresh herbs should stay good in your refrigerator for up to five days if stored properly; cooking experts recommend wrapping them in a damp paper towel and sealing them in an airtight plastic bag.
Of course, you still need to eat your fruits and veggies; these foods offer a wide range of other beneficial phytochemicals, plus vitamins, minerals, and fibre that are essential to good health.
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