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A Case Study In Aggressive Quackery Marketing

With some degree of sadness I recently “outed” a former co-resident of mine who has turned to the dark side and begun putting money-making before truth and science. Without any clear evidence of benefit beyond placebo, platelet-rich plasma (PRP) is now being marketed aggressively as a cure-all for sports injuries. And at about $300 per injection (the NYT reports $2000/treatment), there’s plenty of money to be made.

Like the fake “stem cell” clinics in Russia (where, according to Sanjay Gupta’s recent book, Chasing Life, a person’s fat cells are harvested, washed, and re-injected into their blood stream), PRP also involves injection of autologous body fluids. Essentially, a small amount of blood is drawn from the patient, centrifuged, and the plasma supernatant is then injected directly into tendons and/or joints. After a series of 3 injections (one/month), most sports injuries are “cured.” Of course, most injuries would heal themselves in three months anyway.

It was bothersome enough that Steve Sampson, D.O., began a practice in Los Angeles, catering to those who could afford to do more than the usual RICE (rest, ice, compression, elevation) therapy for sports injuries. But now a nation-wide marketing initiative has begun, using sports celebrities as guinea pigs. Consider the email I received yesterday:

Val,

Superstar athletes have been fighting back from injuries with the help of a new, innovative treatment technique that has enabled them to return to action more quickly.  Two players for the Pittsburgh Steelers, Hines Ward and Troy Polamalu, used this technique to lead their team to victory in Super Bowl XLIII.

Now, that same treatment method offers promising results for weekend warriors and seniors in our region suffering from osteoarthritis in their joints and spine as well as those who’ve suffered ligament and tendon injuries.

It’s called Platelet Rich Plasma (PRP) therapy and one of its leading practitioners in the country is Capitol Spine & Pain Centers, the interventional pain practice in the Washington D.C. area for more than 30 years.

PRP therapy relieves pain by rejuvenating injured tissues.  The process jump-starts and strengthens the body’s natural curative signals.

Capitol Spine and Pain Centers provides PRP therapy at all eight of its locations in Virginia and the District of Columbia. We would be glad to provide you with both a representative of its medical staff and a patient to discuss the benefits of PRP therapy.

To find out more about Capitol Spine and Pain Centers, go to www.treatingpain.com.  Thanks for your time and I look forward to hearing from you.

George Evanko
President
George Evanko Communications
9156 Riesley Lane
Vienna, VA  22182

Notice how this wonderful treatment is not only useful for superstar athletes, but also for seniors and weekend warriors. Yes, the market for PRP is almost unlimited! And aren’t I lucky, there’s a “leading practitioner” of PRP right here in Washington, DC. Now I too can jump start and strengthen my body’s natural curative signals.

Ugh.

As with the most successful forms of pseudoscience, there may be a grain of plausibility here. Knowing that human plasma does in fact contain growth factors that are implicated in wound healing – it’s not complete fantasy that injection of said factors may improve injuries in some way. So I decided to take a fresh look at Medline to see what sort of evidence there may be for the therapy. In my search I found:

1. One abstract discussing PRP’s use in degenerative knee arthritis. The study is not available for review in its entirety – but the abstract suggests that an improvement was noted at 6 months (in pain scores) with a significant worsening at month 12. No control group.

2. One small study that did not find a benefit to ACL healing in the presence of PRP.

3. Quite a number of studies related to the treatment of bone defects (mostly periodontal) with PRP. Most of those showed no improvement or a fleeting, temporary improvement with PRP.

Overall it seems that the dental and oral and maxillofacial surgery literature has found no use for PRP, and the orthopods simply haven’t paid too much attention to it. There is almost no published research related to tendon injuries – the major indication for PRP suggested by Dr. Sampson. So that leaves us with testimonials, celebrities, and true believers who are researching PRP  ”…to help further refine the treatment and demonstrate its efficacy.”

I suspect that, given Dr. Sampson’s recent appearance on The Doctors, he is well and truly committed to marketing his way to an early retirement with profits from PRP. The only thing standing in his way is this nasty little problem of evidence of efficacy. No matter, if it’s good enough for the Pittsburgh Steelers, it’s good enough for grandma.


Posted in: Clinical Trials, Dentistry, Health Fraud, Surgical Procedures

Leave a Comment (25) ↓

25 thoughts on “A Case Study In Aggressive Quackery Marketing

  1. Dr Benway says:

    Steve Sampson, D.O., you are a douchebag.

  2. I’d give it more than a grain of plausibility: perhaps a nugget? It’s an interesting idea. Regardless of the plausibility, though, the hype is certainly way out of proportion to the available evidence.

    I’m fascinated by the large grey area between overt quackery and excessive enthusiasm for dubious interventions.

  3. Dr Benway says:

    Is there such a large grey area?

    I’d think medical scientists would largely agree on what counts as sufficient evidence for a given intervention before we send it out for mass consumption.

    Personally, I’d like two double-blind placebo controlled trials showing PRP injections are safe and effective before we ring up the marketing boys.

    When treatments get pimped before they’re proven, it’s harder to do the trials. Patients aren’t motivated to participate in studies when they can get the treatment without a hassle. Blinding is harder because patients become familiar with the actual product. And a money-making industry becomes established that will challenge inconvenient study results in an unfair manner.

    The process of resolving a manufactroversy around some popular but bogus treatment might take decades. Meanwhile, patients will be ripped off.

    It’s no fair moving the evidential bar to suit. Look at the anti-vax crowd and the vaccine-autism crowd. Both camps emphasize study weaknesses and limitations beyond what we do for other medical interventions. The pubic can’t see the special pleading and are fooled.

    Therapies accepted by virtue of supporting scientific evidence can be later rejected on the basis of new scientific evidence against them.

    We see that all too often therapies accepted without evidence are not rejected when controlled studies fail to show efficacy. For this reason, we must define clearly the evidential bar for novel treatments. And we must insist that the treatment not be offered to the public until that standard is met.

  4. Val Jones says:

    To Paul – yes, I’ll trade grain for nugget. Fair enough. Though I have to say that after reading many tens of abstracts in the oral and maxillofacial literature (they were intrigued by the idea of PRP improving bone and wound healing), there were no data to get excited about -which makes me skeptical about sudden success of a similar treatment on different body parts.

    To Dr. Benway – I completely agree with your arguments. “We see that all too often therapies accepted without evidence are NOT rejected when controlled studies fail to show efficacy.” So true.

    Once the horse is out of the barn, perception is 9/10ths of reality and that’s what the marketing engine is all about. Early adopters make lots of money, patients are hoodwinked, and the snake oil engine rolls on to something new when they’re finally shown to be wrong about their miracle cure of the day.

    And this is why I blog. Because I have this nagging suspicion that if critical thinkers raise their voices and nip things in the bud, we may be able to decrease the volume of snake oil being promoted to our patients. Once the ideas take root – false as they may be – they’re much harder to counter. At least now (if the Google gods favor us) when people search for PRP they may find something other than glowing testimonials.

  5. Dr Benway says:

    We’re all aware of the cases against BigPharma –e.g., promotion of a drug for an indication that’s still off-label, not publishing negative studies, ghost writing articles, creating pseudo-peer review journals, and so on.

    But I think we should wonder, why is so much good science done by BigPharma? If pharma companies are the evil empire capable of buying any research outcome they want, how is it that they put out so many controlled studies that independent parties are able to replicate? How is it that they abandon so many new drugs that seem promising before even completing a clinical trial?

    I think the rules largely work to incentivise honesty. Companies don’t want faked data from researchers. They need to know the actual efficacy and safety of novel drugs under study. They don’t want to invest tens of millions into large clinical trials that can’t be replicated.

    Contrast this with how things work on the supplement side. The vitaministas aren’t required to pay for large clinical trials. All they need is an appearance of usefulness in mice or rats and they’re off to the races. They have little incentive to discover the true efficacy of their products.

    Is the FDA at all concerned with this promotion of PRP for musculo-skeletal injuries without controlled trials? If not, why not?

  6. magra178 says:

    even with plausability, there’s no safety evidence. I’m sorry my Steelers are the poster team for this, and my two favorite players too.

  7. Telum says:

    I got into medical school today! Thats one more who will practice science based medicine

  8. Kausik Datta says:

    Excellent arguments, Dr. Benway. That is what I don’t understand at all. How can a medicine, affecting lives and livelihoods of people, be released only on the basis of plausibility as the only parameter? I too would like to see double blind RCTs for PRP before going ga-ga over their benefits.

    OT: please don’t engage th1th2!!

  9. Dr Benway says:

    OT: please don’t engage th1th2!!

    Awr, don’t take away my chew toy, Daddy!

  10. Dr Benway says:

    Good on ya, Telum! w00t!

    That thin envelope was one of the happiest days of my life. I was on a cloud for about a week.

  11. pmoran says:

    It’s not that plausible. Traumatised areas are soon flooded with everything that a bit of plasma contains as part of the normal wound healing response.

    It is invasive — some patients will surely be made worse.

  12. I don’t think PRP is in the grey area. It’s nugget (or grain) of plausibility does not pardon the clearly excessive hype and ridiculous marketing language like “rejuvenating injured tissue” — bah! As quackery, it may not be as egregious as homeopathic inoculation against malaria, but it’s definitely quackery.

    But dial the hype down a bit, and upgrade the plausibility from nugget to something definitely worth thinking about, and you’ve got grey zone material: interventions that are definitely not yet evidence-based, but not exactly absurd either, and promoted with ordinary overconfidence and enthusiasm as opposed to actual hype.

    Is it quackery to just be a bit too bullish on a bad idea? If so, there’s a great deal of quackery above and beyond the usual suspects!

  13. Oh, and @pmoran … good points. A question, though: isn’t the idea of PRP to inject far more platelets than you’d ever get in typical wound healing? And, if so, would that increase the plausibility of a therapeutic effect?

  14. TsuDhoNimh says:

    I read several of those studies, and the periodontal use was more as a glue that was auto-origin and would be easily absorbed after the healing started.

    The stuff is incredibly sticky.

  15. Dr Benway says:

    Is it quackery to just be a bit too bullish on a bad idea?

    Is it a bad idea? Maybe, maybe not. And that’s the problem right there.

    Drug companies must complete two clinical trials with appropriate controls prior to FDA approval. What’s wrong with applying that same standard to PRP?

    The only downside to waiting for proof of efficacy and safety before trying to sell PRP to the credulous would be the impact this requirement might have upon Sampson et al’s retirement portfolio. Ergo, douchebag.

  16. pmoran says:

    Paul; “A question, though: isn’t the idea of PRP to inject far more platelets than you’d ever get in typical wound healing? And, if so, would that increase the plausibility of a therapeutic effect?”

    I suppose it is a matter of opinion.

    “If something is good, more is better” is by no means a reliable medical principle.

    Even if it applied here, it is not obvious to me that an occasional injection of PRP will deliver significantly more of anything to the right places than will the constant perfusion under conditions of increased vascukarity and blood vessel permeability that apploes virtually from the instant of injury.

    But I may be wrong.

  17. Exactly: we just don’t know. Not only is there nothing wrong with applying the same standard to all interventions, there is everything right about it.

    Let’s do it! All together now … ;-)

  18. @pmoran, yep, works for me. “More is better” is one of my biggest pet peeves in therapeutic logic, in fact. I don’t think that “you might be wrong” even applies to estimates of plausibility. You’re not asserting that it’s definitely impossible: you’re just saying that you wouldn’t bet on the therapeutic value of “more platelets, more!” Neither would I.

    And I also wouldn’t be shocked if it turned out that it helped in certain circumstances. Hence the “nugget” of plausibility. There are indeed SOME biological predicaments in which more of a thing is just what is called for!

  19. stargazer9915 says:

    # Dr Benwayon 22 Oct 2009 at 8:53 am
    Steve Sampson, D.O., you are a douchebag.

    All I can say is “Ditto”

  20. Significant new evidence on the efficacy of PRP was just published in JAMA. The results were predictable. I just posted my report on the new PRP evidence on SaveYourself.ca.

  21. drhanson says:

    I like how some of you preach efficacy for alternative type treatments, but all still likely prescribe antibiotics for childrens ear infections (ineffective and against amer. acad of pediatricians recommendations). Reasearch also shows the ineffectiveness of knee surgery, LESS effective than a sham procedure (only the incision was made). Yet when a therapy that doesn’t involve a billion dollar drug comes along there is skeptisism abound. If you are playing by the rules of wanting science backed conclusions at least apply them across the board and not just to treatments you have a problem with. Big Pharma is the biggest hype machine since Hitler, so a DO’s appearance on “The Doctors” and an email is hardly big news.

  22. drhanson wrote: “but all still likely prescribe antibiotics for childrens ear infections”

    That is a huge assumption, which I happen to know is also wrong. You just make up assertions to support your point – but that simply reduces your point to propaganda.

    We advocate high standards of science-based medicine across the board – and we have dealt with both surgical and pharmaceutical treatments on this blog – if you bother to look.

    I think a far bigger hype machine than “big pharma” (which I am not defending, just to clarify) is the pro-CAM hype machine that produces the knee-jerk false assumptions as in your comment.

  23. Harriet Hall says:

    Steven Novella pointed out “we have dealt with both surgical and pharmaceutical treatments on this blog – if you bother to look.”
    In fact, I criticized Big Pharma just last week.
    http://www.sciencebasedmedicine.org/?p=3278

    drhanson’s comments can be disregarded. He is just trolling and setting up straw men – and he even mentioned Hitler. And he can’t even spell skepticism.

  24. David Gorski says:

    @dr hansen:

    You clearly aren’t a regular reader of this blog. If you were, you’d know how ignorant your claim that we ignore big pharma and medical devices is. Here are just a few examples of criticisms of big pharma and expensive procedures:

    1. Vertebroplasty http://www.sciencebasedmedicine.org/?p=665
    2. Conflicts of interest http://www.sciencebasedmedicine.org/?p=2466
    3. Seeding trials by big pharma http://www.sciencebasedmedicine.org/?p=192
    4. Failures of big pharma to publish negative or equivocal drug trials http://www.sciencebasedmedicine.org/?p=215
    5. Fraud in science-based medicine http://www.sciencebasedmedicine.org/?p=408
    6. Radiation from CT scans and cancer risk http://www.sciencebasedmedicine.org/?p=3154
    7. The risks of too aggressive screening for breast and prostate cancer http://www.sciencebasedmedicine.org/?p=2249
    8. Nurses threatened with jail for reporting a doctor’s dubious business practices http://www.sciencebasedmedicine.org/?p=1771
    9. Overdiagnosis in mammography screening http://www.sciencebasedmedicine.org/?p=565 http://www.sciencebasedmedicine.org/?p=477
    10. How hot areas have more dubious research http://www.sciencebasedmedicine.org/?p=553
    11. Big pharma paying to publish a fake medical journal http://www.sciencebasedmedicine.org/?p=477

    I could come up with more examples, but I’m tired. The bottom line is what Steve said. We advocate for the highest scientific standards in medicine, period. In fact, we consider distinguishing alt-med from scientific medicine to be a false dichotomy. Medicine that is validated scientifically is medicine, regardless of whether it started out as “alternative” or not.

    Oh, and regarding your Hitler reference, two words: Godwin’s law.

  25. drhanson, the knee surgery research you referred to is presumably the fascinating Moseley et al study in NEJM in 2002 (its findings were echoed by another NEJM study and a Cochrane review last year). Good stuff. Interesting science.

    However, you reference it recklessly, using it to make the point that all knee surgery is useless, and by extension all surgery. It was a study of the effectiveness of debridement for osteoarthritis. Generalizing Moseley’s findings to “all knee surgery” is daft. Perhaps you’ve heard that that there are other kinds of surgeries for other kinds of knee problems?

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