In Wired Magazine, writer Steve Silberman, wrote an article in August of 2009 entitled, “Placebos Are Getting More Effective, Drugmakers Are Desperate to Know Why.” This is quite an eye-opening article. I find it amazing to think that Big Pharma has actually been worried about the lowly little placebo for a very long time and I thought it might be interesting to share a bit of it what is happening in order to take a serious look at it.
Many people do not even know where the term ‘placebo effect’ comes from. But in truth it can be traced to a little white lie, according to Silberman, who tells the story of an Army nurse during World War II in Italy who was assisting an anesthetist named Henry Beecher, who was caring for our US troops under German bombardment. When their morphine supply had trickled down to nothing, this nurse assured a wounded soldier, that he was getting a shot of a potent painkiller, though her syringe was loaded only with, saline solution (salt water). Amazingly, the bogus injection relieved the soldier’s excruciating pain and kept him from going into shock!
Beecher returned ultimately to Harvard and became one of the USA’s leading medical reformers. He was so inspired by the nurse’s clever ruse, that he launched a crusade to promote a method of testing new medicines to find out whether they were truly effective. At the time, the process for testing the efficacy of drugs was not very good. Pharmaceutical companies would simply give volunteers some experimental agent of some sort until the side effects would overcome the presumed benefits. Beecher proposed that if test subjects could be compared to a group that received a placebo (a sugar pill), health officials would finally have an impartial way to determine whether a medicine was actually responsible for making a patient better.
The placebo plot thickened; in a 1955 paper entitled “The Powerful Placebo,” which was published in “The Journal of the American Medical Association,” Beecher described how the ‘placebo effect’ had undermined the results of more than a dozen trials by causing improvement that was mistakenly attributed to the drugs being tested. He demonstrated that trial volunteers who got real medication were also subject to placebo effects; the act of taking a pill was itself somehow therapeutic, boosting the curative power of the medicine. Only by subtracting the improvement in a placebo control group could the actual value of the drug be calculated.
The article caused a sensation. By 1962, the news of birth defects caused by the drug, Thalidomide, and its tragic consequences were of such monumental proportions, they hit every front page of America’s Newspapers. The only silver lining of this horror story was that it caused Congress to amend the Food, Drug, and Cosmetic Act, requiring trials to include enhanced safety testing and placebo control groups. Volunteers would be assigned randomly to receive either medicine or a sugar pill, and neither doctor nor patient would know the difference until the trial was over.
Beecher’s double-blind, placebo-controlled, randomized clinical trial—or RCT—was enshrined as the gold standard of the emerging pharmaceutical industry. Today, to win FDA approval, a new medication must beat placebo in at least two authenticated trials. The question now can be carefully posed…are they worth the paper they are printed on? Why you might ask? Because, even the color of the pills in these studies is at play; yellow is the best for antidepressants as it is like a little dose of sunshine, red pills provide a stimulating effect and give you a kick in the behind, green and perhaps even blue, add a bit of chill to the pill, and white are more soothing to the gut, particularly as an antacid even if they only contain lactose (milk sugar).
It also seems that more pills are better so that if you take your placebo several times a day you get better results and if your pills are embossed with a name brand like Tylenol, the name branding on them seems to make them work better than generic, even if the person offering the tablet to the user, says they are the same! Now how about that? Can we see the power that we each hold in our own belief systems!
It is true, that Beecher in fact did help to cure the medical establishment of its own brand of quackery, but it had a really big side effect – it cast the lowly little placebo as the villain in RCTs, and Beecher ended up stigmatizing one of his most important discoveries. The fact that even dummy capsules can kick-start the body’s recovery engine have now become a problem for drug developers to overcome, rather than a phenomenon that could guide doctors toward a better understanding of the healing process of our miraculous bodies and how to drive it most effectively into perhaps healing itself. Where would the ‘big bucks’ be in that?