Placebos Get Better Over Time: The Weird World of Placebos

Written by on September 20, 2011 in in the news, research with 0 Comments

More from the weird and wonderful world of clinical trials and the mysterious Placebo Effect.

We know that somehow even dummy pills can kick-start the body’s recovery engine. This latest article from WIRED tells us that drug developers are noticing that over time that the placebo effect is increasing.

Drugs that once clearly outperformed placebo are losing their edge. Also an increasing trend of new drugs in development are unexpectedly failing to outperform placebo.

How is this possible? Read on to find out.

Encouraging News

One good thing for consumers is that the FDA mandates all new drugs must outperform placebo in authorized blind trials. Thus drug companies must come to grips with the placebo effect (or perhaps better called placebo response as we read below) in order to be able to develop new drugs.

The encouraging bit of this is that we will discover and be able to prove our body’s in-built recovery and healing ability.

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.

By Steve Silberman 08.24.09

From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo.

Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo.

Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.

Why is This So ?

Now, after 15 years of experimentation, he [Bendetti] has succeeded in mapping many of the biochemical reactions responsible for the placebo effect, uncovering a broad repertoire of self-healing responses. Placebo-activated opioids, for example, not only relieve pain; they also modulate heart rate and respiration. The neurotransmitter dopamine, when released by placebo treatment, helps improve motor function in Parkinson’s patients. Mechanisms like these can elevate mood, sharpen cognitive ability, alleviate digestive disorders, relieve insomnia, and limit the secretion of stress-related hormones like insulin and cortisol.

In one study, Benedetti found that Alzheimer’s patients with impaired cognitive function get less pain relief from analgesic drugs than normal volunteers do. Using advanced methods of EEG analysis, he discovered that the connections between the patients’ prefrontal lobes and their opioid systems had been damaged. Healthy volunteers feel the benefit of medication plus a placebo boost. Patients who are unable to formulate ideas about the future because of cortical deficits, however, feel only the effect of the drug itself. The experiment suggests that because Alzheimer’s patients don’t get the benefits of anticipating the treatment, they require higher doses of painkillers to experience normal levels of relief.

Benedetti often uses the phrase “placebo response” instead of placebo effect. By definition, inert pills have no effect, but under the right conditions they can act as a catalyst for what he calls the body’s “endogenous health care system.” Like any other internal network, the placebo response has limits. It can ease the discomfort of chemotherapy, but it won’t stop the growth of tumors. It also works in reverse to produce the placebo’s evil twin, the nocebo effect. For example, men taking a commonly prescribed prostate drug who were informed that the medication may cause sexual dysfunction were twice as likely to become impotent.

Finding a Way Out

Big Pharma wants to know why more and more of their drugs are failing to beat placebo.

Under the auspices of the FNIH, Potter and his colleagues are acquiring decades of trial data—including blood and DNA samples—to determine which variables are responsible for the apparent rise in the placebo effect. Merck, Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis, Johnson & Johnson, and other major firms are funding the study, and the process of scrubbing volunteers’ names and other personal information from the database is about to begin.

In typically secretive industry fashion, the existence of the project itself is being kept under wraps. FNIH staffers2 are willing to talk about it only anonymously, concerned about offending the companies paying for it.

In standard trials, the act of taking a pill or receiving an injection activates the placebo response. In open/hidden trials, drugs and placebos are given to some test subjects in the usual way and to others at random intervals through an IV line controlled by a concealed computer. Drugs that work only when the patient knows they’re being administered are placebos themselves

Ironically, Big Pharma’s attempt to dominate the central nervous system has ended up revealing how powerful the brain really is. The placebo response doesn’t care if the catalyst for healing is a triumph of pharmacology, a compassionate therapist, or a syringe of salt water. All it requires is a reasonable expectation of getting better. That’s potent medicine.

I’d recommend reading the whole article: Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.

Why Should I Care?

All rosacea sufferers need to be aware of the powers of the placebo effect, as it needs to be included in all evaluations of new treatments.

If a new treatment can’t demonstrate that it is superior to placebo, well then we might be better of taking sugar pills (or just using the inactive vehiclie in a topical) and hoping for the best.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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