By Kim Evans
A Wired UK article just told us a dirty little secret that the pharmaceutical drug world would rather keep quiet. That fact is: drugs are having a difficult time beating the placebo effect, and increasingly so. In fact, they’re finding the placebo effect is getting stronger in people, making it more difficult for drugs to show any improvement over it. The credit for the increased placebo effect has been attributed to the increase in consumer advertising, which makes many consumers “believe” more in the drugs and their effects.
Because the placebo effect is getting stronger, many widely distributed drugs would have had a hard time getting approval to begin with, if they were tested against today’s placebo effect. Many drugs, notably Prozac, have also been shown to falter when compared to placebo – after they’re already on the market.
A Saatchi & Saatchi advertising executive explains the key to producing a good pharmaceutical ad: it’s in making the association between the drug and other aspects of life that promote peace of mind, like playing with your kids or reading a good book.
It’s Madison Avenue type stuff, designed to play on your emotions and specifically, to boost sales. These messages appear to be working because many people keep calling on doctors for more drugs, which is the drug company’s number one goal. But, interestingly, the same mechanism also seems to be messing up the new drug approval process for drug companies.
Wired tells us, “The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis” and that “half of all drugs that fail in late-stage trials drop out because of their inability to beat sugar pills.” Eli Lilly’s next-generation antidepressants haven’t been doing better than a placebo in seven out of ten trials. It wasn’t long ago that Merck withdrew its “highly anticipated medical breakthrough” antidepressant for the same reason; it didn’t beat sugar pills.
It’s interesting because placebo pills are often sugar pills, and sugar is known to depress the immune system for hours after it’s taken. So, in truth, drug companies are having a difficult time competing against an immune system depressant.
William Potter, psychiatrist turned Eli Lilly drug developer, found himself baffled by the evidence that drugs he’d long been prescribing were now failing against placebos. So, he started digging around in Eli Lilly’s trial database, a database that included trials the company didn’t make public and preferred to keep quiet.
Other research has found that patients do better with a caring doctor who takes time with them, compared to a non-caring doctor who doesn’t bother with communication, even if they are both given the same placebo.
These random factors can sway drug trials one way or the other, yet drug companies aren’t required to submit for regulatory review all of the tests they run on a particular drug. They can submit just the ones they do well in and keep the ones that they fail to themselves, even if the factors for “doing well” are as esoteric (and non-scientific) as the color of the pill given, the branding of the pill, the price of the pill, or which country the trial was held.
Fabrizio Benedetti studied the placebo effect on his own, because funding couldn’t be found to study something the drug industry considers to be getting in the way of profits.
Building on previous research, Benedetti found that when someone is given a pill, the brain expects change to happen. Based on that expectation, the brain often then starts producing its own pain-relieving medicine, which can reduce pain and even regulate heart and respiratory functionality.
Instead of working to understand how the body can heal itself, drug companies see this, the placebo effect, as a nuisance. In fact, these days, daily doses of immune-depressing sugar pills might cause bigger problems for drug companies than their direct competitors do.
It’d be curious to see what would happen if the sugar pills were replaced with a whole foods diet, or supplementation with placebo herbs like cat’s claw, garlic, or other known immune system enhancers. Perhaps, this should become the standard for the testing of pharmaceutical drugs, as testing against substances that are known to depress the immune system isn’t really a level playing field, even if the drug companies are routinely failing.
Of course, if this were to happen, far fewer drugs would pass the already flimsy approval requirements that allow for the cherry picking of data and hiding of negative results. And this isn’t something the drug industry wants.