Sunday, February 24, 2013

Do Probiotics Work? Marketing Mania Tramples Science



My kids know that I enjoy a spirited argument.   During the days when the dinner table was our public forum, I tried hard to offer a responsible voice of dissent on the issues before us.  I admit now that the view I espoused was not always my own, but one that I felt merited inclusion in the discussion.  I still do this with them and to others in my life who are willing to succumb to probing of the mind.   I willingly subject my own mind to the same process. 

Because I am a gastroenterologist, folks assume that I have special expertise in nutrition.  I should, but I don’t.  Perhaps, medical education has evolved since I was in medical training, but in my day, a soft subject like nutrition was bypassed.   I am hopeful that I can remedy this knowledge vacuum in the years ahead.
These days, nutrition is part of the burgeoning tsunami of wellness medicine, a discipline that races beyond known science as it seeps into the marketplace.

Several times a week, I am queried on my view of probiotics, which are bacteria that confer health benefits on the human who ingests them.   If you were to survey the public, I suspect that a majority would express that probiotics promote health and are effective in treating or preventing various maladies.
  
These products are included in the billion dollar enterprise of alternative medicine that is not subjected to any Food and Drug Administration (FDA) oversight.  Their claims are very difficult to study and there is no standardization in the industry of what constitutes probiotic treatment. This a different universe that conventional drugs inhabit.  These medicines, prescribed by physicians, are subjected to rigorous oversight by the FDA and must demonstrate safety and efficacy.  Alternative product purveyors, free from these constraints, can appeal to our New Age beliefs with promises that are seductive but unproven.  They promise better health but don’t have to prove anything. 

If you were in the business of selling medicine, would you choose to spend gazillions dollars and several years praying your drug gets through the FDA, or promote a probiotic that a public is ready to swallow on faith?   If you’re stuck on this question, then consider my alternative blog MDWhistleblower for Dummies for remediation.

Do probiotics treat or prevent disease?  Are these companies overpromising?   Clearly,  the marketing claims are a light year or two beyond verifiable and supportive science. 

I know that many of us want probiotics to be the panacea for what ails us.  I know that wellness and preventive medicine have become a religion for many of us.  I suggest that we need some Old Fashioned wisdom to restrain New Age converts.

Don’t misunderstand me.  I’m not dissing Alternative Medicine acolytes.  Does their stuff really work or is  belief of efficacy sufficient?   Why aren’t these companies utilizing the scientific method to determine if their potions are just placebos?   Kick this issue around your own dinner table and make sure that dissent is on the menu.

9 comments:

ARCpoint Labs of Elk Grove Village said...

I think that the benefits of probiotics and other similar medicines could be proven by science that they work if the pharmaceutical industry was willing to put the money towards the research rather than their current medicinal options.

Matt said...

It's interesting. I always wonder why people put so much faith in probiotics. I get a lot of stares when people ask me "which probiotic is the best to prevent yeast infections" and I respond, "I don't know". I often tell them about the lack of studies and then they bring up something about Dr Oz. It happens often. Usually pharmaceutical companies have to design, execute and publish studies before they generate enough hype to bring in the big money. But somehow the hype and money came first and we're still waiting on the studies. I think people assume efficacy because the probiotic concepts and mechanisms are really easy to wrap your head around. Whereas, the general public might not be so welcoming to the idea that beta-blockers can save lives post-MI.

arcpointlabsKC said...

"I suggest that we need some Old Fashioned wisdom to restrain New Age converts." I selected this quote from the article because it says so much about using common sense to evaluated any piece of information that is making a medical claim or any claim in general

Michael Kirsch, M.D. said...

Don't hold your breath waiting for high quality studies on probiotics. As I point out in the post, the manufacturers have a strong incentive to forego scientific scrutiny and to market their products directly to a public who has an insatiable appetite for all things wellness and will pay cold hard cash for the promise of a panacea. Why take the risk of proving efficacy if your customers are already satisfied with your claims and are emptying warehouse shelves at a dizzying pace?

Christine Sutherland said...

I think it's quite ingenuous that many of the companies touting various supplements quote all sorts of shoddy "clinical trials" and almost never put their miracle product up against a placebo.

The Herbalife weight loss shake is a case in point. It does very well in the market, but independent studies show it is no better than placebo.

Michael Kirsch, M.D. said...

Christine, why do you think these potions are so popular? Doesn't the public care about scientific demonstration of efficacy? Are we still all willing to buy snake oil and other cure alls? Thanks for commenting.

Anonymous said...

what about studies about certain probiotics used for h pylori or c diff diarrhea?

"Probiotics for the treatment of pediatric helicobacter pylori infection: a randomized double blind clinical trial."

Barbara said...

I got into some GI difficulties with what I thought was C Difficile after a round of antibiotics my dentist prescribed. Being an R. N. from a medical family, I am very good in areas involving nutrition (99th percentile on state boards!), but I've never advocated probiotics. I don't generally recommend supplements unless one has a proven deficiency in something. When I had some serious bowel concerns after taking that antibiotic, I did buy a probiotic, however, and of course it did no good. I was about ready to call a G.I. specialist to very reluctantly schedule a colonoscopy when it was discovered that I had a parathyroid tumor. It was evident in my high blood calcium levels which had been monitored 4-6times a year by my cardiologists, and they just watched it climb for 5 years without telling me about it! Finally it got so high that a PTH was ordered, and voila - there was the culprit. While awaiting surgery to have it removed, I had a chat with my anesthesiologist, who asked about G. I. problems. He said that 98% of patients with a PT tumor have serious G.I. issues; usually GERD, but they can occur anywhere in the gut, too. Within a week post-op, my issues were gone, except for my skeletal issues (I now have a -4 bone density scan, severe osteoporosis and osteopenia resulting in scoliosis!) but I no longer have G.I. problems. It might be a good idea to do a simple blood calcium and PTH on patients complaining of bowel problems. Dr. James Norman, Tampa, Florida, has great information online. The entire top floor of Tampa General Hospital belongs to him and his team for dedicated parathyroid surgery, of which they do about a dozen per day. It doesn't take a severely high calcium level to indicate the possibility or even the probability of an adenoma.

AB said...

No value in probiotics? The evidence is epic and has been for years. That you don't know it doesn't mean it doesn't exist.

You ask why probiotic companies don't do clinical trials? Seriously? You don't know the answer.? And you think the FDA is a benign place with wisdom? Oh boy.

Even the Ass't Dir of Drug Safety said in 2005 that as the FDA currently exists it is not prepared to safeguard the American public. Then there were the scientists that outed the place for systemic fraud a few years ago. The FDA was forced to admit the letter was not a hoax.


But back to probiotics - http://www.medicalnewstoday.com/releases/270546.php

This is one of many - this one links autism to gut microbes.

quote:

"Scientific evidence is mounting that the trillions of microbes that call the human body home can influence our gut-linked health, affecting our risk of obesity, diabetes and colon cancer, for example. But more recently, researchers are discovering that gut microbes also may affect neurology - possibly impacting a person's cognition, emotions and mental health, said Knight, also a Howard Hughes Medical Institute Early Career Scientist and an investigator at CU-Boulder's BioFrontiers Institute."


One day the pioneers will be recognized, but meanwhile, we have to listen to the pharmco trained. It's a shame the wisdom of our body is held captive by the chemical world. BTW - did you know the FDA WAS the Dept of Chemistry and then the Rockefellers got involved and we all know that wasn't for altruistic reasons.

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