Appropriately Skeptical

From time to time I see an ad from a local doctor promoting stem cell therapy for pain. It includes one endorsement telling how the office was so easy to work with and how the pain went away. For some time now I have been skeptical about the validity of this promotion. I thought stem cell research was not yet in the mainstream of medical practice, and I know that endorsements are not reliable evidence. It seemed suspicious, so I decided to look into it.

The promotional material on line states in part: “Stem cell therapy uses your body’s most powerful and flexible cells to promote natural regeneration in damaged joints.” It claims to be effective for a list of conditions: surgical wounds, tendon damage, severe muscle strain, arthritis, damaged cartilage, torn meniscus and many other joint and soft tissue injuries and conditions.

“The stem cells … come from your own body … a small quantity of bone marrow from your large hip bone.” (Using the recipient’s own stem cells avoids the need for FDA approval.) The on-site lab processes the harvested cells. The doctor then can “precisely inject your stem cell mixture where you need it … where they morph into new cell types” and provide “long-lasting relief” for “many [but not all] patients.”

My first stop was WebMD with a sub-headline reading: “Unproven, Risky Treatments Mislead Patients to Seek Cutting-Edge Therapy.” International Society for Stem Cell Research (ISSCR) “advises patients to seek only stem cell treatments being tested in clinical trials approved by the FDA”… or some approved smaller studies.

There is a lot of information on the site but it is summarized like this: “Every treatment has some risks. So the question comes down to whether the benefits outweigh the risks. And those studies haven't been done yet.” 

This Healthline report from about 18 months ago says that stem cell therapies are being promoted for a wide variety of conditions, but “very few of these applications have any scientific backing, [however] stem cell therapy for knees has been the subject of quite a few promising studies.” It would be a big improvement over knee replacement, but promising studies hardly qualify a procedure for routine outpatient application. They list the cost of this treatment at “approximately $3,000 to $5,000 per knee, depending largely on geographical location.” 

The FDA gives much of the same information. “Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefit—or if the product is safe to use.”

Consumer Reports chimes in with a sub-headline: “A new industry is booming. But critics worry that the treatments are ineffective and dangerous.” Here is a very brief summary: “Stem cells are special cells with the potential to repair damaged tissue and organs.” But “not all of them are possessed of equal power.” According to the current scientific consensus, the therapeutic potential of stem cells taken from fully developed tissues, adult cells, is believed to be much more limited. (Does this include marrow from hipbones? I wonder.)

That Consumer Reports piece is a long article with many warnings about the confusion in the field and the inability of regulators to keep up with the proliferation of clinics, both legitimate and otherwise.

Another reason I am skeptical is that the same doctor offers many other questionable services including platelet-rich plasma (PRP), calling it “one of the most powerful natural healing methods available today.” Some conditions include dry eyes, hair loss and erectile dysfunction.

The Pain Science website opinion published earlier this year describes it this way: “injections bathe troubled cells in a concentrated mixture made from your own blood. Hopefully this stimulates healing where it is otherwise failing … but no one really knows for sure yet.” Regardless, it’s not hard to find someone willing to do it for you, but it’s not cheap. “Without any clear evidence of benefit beyond placebo, PRP is now being marketed aggressively as a cure-all for sports injuries.”

I did this research not because I would consider going to a pain specialist unless I was referred by my primary care doctor. I did it just to show how careful we need to be to avoid spending a lot of money on dubious treatments. 

I didn't name this doctor because I'm sure there are similar ads running all over the country. I am not demonizing any doctor who may truly believe in such treatments, but it is a warning to patients everywhere. 

It is nearly always better and safer to be appropriately skeptical.

One More Time – The Placebo Effect

Way back in early 2012, I first brought up the placebo effect – the tendency of the body to heal itself when belief in the cure is strong. How it works is still a mystery but that it does work is indisputable.

The example I used over 6 years ago was a $30 performance wristband, one endorsed by famous athletes and touted to improve athletic performance. In a test people were given the advertised wristband and exposed to some physical performance and balance tests. The before and after results showed some improvement. Then they were given a similar-looking one-dollar replacement band and told it was also special, performance on physical and balance tests improved comparably. Conclusion: it wasn’t the band at all; it was the perception that they were getting some extra, outside help – mind over matter.

Since then I have mentioned the placebo effect in essays warning about vitamins, acupuncture, forest bathing, chiropractic, healing crystals, gluten-free diets, cryotherapy, homeopathy, ear candling, essential oils and a few other subjects. (Wow, that’s a lot of toes to step on in only six and a half years!)

The point is not to make people angry and defensive, but to make them aware of the difference between science and marketing, and how the placebo effect can lead to an erroneous conclusion that a treatment really works.

When a cure is proposed, competent scientists will split a relatively large group in two, randomly assigning one to test the treatment while giving the other a placebo. Both groups usually show some improvement due to the placebo effect. To validate the treatment however, the improvement of the treated group must be significantly better than that of the control group. Otherwise they declare the treatment “no better than a placebo,” that is, no better than no medicine at all.

The placebo effect explains many of the endorsements we hear from celebrities, friends and neighbors. They sincerely (and enthusiastically) believe whatever they are recommending has beneficial effects, but with no scientific evidence it may be “no better than a placebo.” When you buy one of these products, the money spent is money wasted. That’s why the small print in ads, where they explain how the FDA has not approved their magic formula, they often add something like “results will vary.”

That takes us to a health story from England where the BBC reported a pure placebo experiment. With help from University of Oxford, they tried to see if they could “cure real back pain with fake pills.”

One hundred people with severe back pain were asked to participate in a study of a powerful new painkiller. What they didn’t know is that everyone would be given realistic looking pills that were really placebos, “capsules containing nothing but ground rice.”

The blue-and-white-striped pills “came in bottles, carefully labeled, warning of potential side effects and sternly reminding patients to keep out of the hands of children” to further the impression that this was powerful stuff.

Three weeks later researchers found “nearly half of our volunteers reported a medically significant improvement in their back pain” and that those who spent a little more time with a doctor merely discussing the pills were more likely to improve. In one case, a man went off his morphine but continues to take the ground-rice pills.

Placebo effect is not a trick that works only on the gullible. Taking a placebo can cause the body to release endorphins, natural painkillers. And sometimes subjects improve even when they know they are taking a placebo.

But that doesn’t mean the gullible aren’t tricked. In the earlier case of wristbands, even after the people learned that there was no difference and the improvement in both cases was psychological, they still wanted to buy the $30-wristband over the equally effective $1 bands. It’s like when people think the same wine tastes better when the bottle has a higher price tag. 

It does no good to understand science when critical thinking fails to kick in.

Pain, Responsibility and Perspective

Earlier this month a few news stories appeared about chronic pain.  The Institute of Medicine reported to the NIH that over 116 million Americans suffer from chronic pain costing the nation around $635 billion each year.  When I see data like this, I naturally think about behavior – what we are choosing, doing, believing that is healthy and positive, and what might be detrimental.  How much of the $635 billion is wasted by poor choices?  I don’t mean to minimize anyone’s real pain, but with almost one in two adults reporting chronic pain, I do see the possibility of failures in responsibility and perspective.

The study presents a “blueprint” with a host of interventions to address the problem and to educate “patients” on how to manage their pain.  But others professionals point out that people too often look to a quick prescription for relief.  This puts their problem in the hands of someone else, classic low-responsibility behavior.  I’m sure we all know someone who does something or eats something that causes them pain, but then just takes a pill instead of heeding the message from his body to change the behavior.  Remember, low-responsibility behavior is an invitation for outside interference in our lives.  Recommendations for pain management actions before resorting to medication already exist.  They include regular exercise, meditation and acceptance. Acceptance of pain is not a kind of martyrdom; it’s changing the focus.  “OK, it hurts, now let’s get on with living.” 

That leads to the perspective question – I wonder where these 116 million came from.  There are about 312 million people in the US, but less than 250 million adults.  The report doesn’t address whether this is a growing problem, but I don’t recall that over 45% of adults in chronic pain was an issue in the past.  What has changed over the last 40 or 50 years?  Are adults indulging in more dangerous or strenuous activities, have they mysteriously started to hurt more, has diagnosis increased, or have they just developed new expectations, expectations that life should be totally pain-free?

Joseph Campbell paraphrased Buddhist teaching calling us to “participate joyfully in the sorrows of life,” to recognize that life contains hardship and to live affirmatively in the face of that unavoidable sorrow and suffering.  Most of us know that this is a more realistic expectation.  Our perspective guides our choices.

I have many questions about this subject and feel we have not been given all the facts, but I have a strong suspicion that a government study of pain in the news is another indication of some lack of perspective and responsibility in our society.  It seems like one more issue that can be resolved by us rather than by a government program.