Dec 06 2012

Trust Me – Evidence is Coming

Both here and at Science-Based Medicine I and my co-bloggers often tackle health products that are marketed with unsupported claims. The pattern is now well established – the product is sold as a “supplement” so that it doesn’t have to deal with the pesky FDA, the claims are vague “support and enhance” nonsense, the products are generally good for whatever ails-ya, testimonials or worthless in-house studies are offered in place of peer-reviewed research, and the whole thing is cloaked in sciencey but meaningless technobabble. Some products are also sold through multi-level marketing (MLM), which itself is a highly dubious (if technically legal) practice.

It is very common, especially for products sold through MLM, for someone who sells the product to appear in the comments or to send in an e-mail defending the product. The tone is very different from the critical comments we get from “true believers” – the believers tend to be more angry and personal, while the sales reps speak in talking points as if they are reading from a brochure. The formula there is well-established as well. The same talking points pop up again and again, it’s all boilerplate.

Recently Harriet Hall wrote an excellent article at Science-Based Medicine about a product called ASEA, which is essentially salt water. Selling “magic water” is a great scam, and there are endless variations of it. There is a certain psychological appeal to water which makes it easy to believe it has healing properties. It’s also cheap, safe, and easy to distribute. Water, in a way, is the perfect snake oil – just add some pseudoscience. I won’t duplicate Harriet’s article, which covers the topic of ASEA well, but I will give a quick summary. ASEA is nothing but salt water. The company claims it has been treated with a proprietary process to create:

ASEA is trillions of stable, perfectly balanced Redox Signaling Molecules suspended in a pristine saline solution—the same molecules that exist in the cells of the human body.

What are “Redox Signaling Molecules?” A Google search indicates that the only mention is within ASEA marketing itself. A Pubmed search brings up article about redox signaling, but nothing about redox signaling molecules. Redox refers to oxidation/reduction reactions: oxidation is the gain of oxygen or loss of an electron, while reduction is the opposite. The legitimate biological concept here is that redox reactions are sometimes used by the body as a signal to trigger other biochemical or cellular reactions. Oxidative stress and anti-oxidant activity (which involves redox reactions) seem to exist in a homeostasis. The whole antioxidant craze likely failed to produce any real results because it failed to consider this homeostasis and looked only at one end of the equation. ASEA’s nonsensical claims make the same mistake but from the other end.

So even if ASEA’s chemical claims that their salt water is special and contains “redox signaling molecules” were true,  their biological claims that such molecules would have health benefits, and that they can be increased by drinking them, are extremely unlikely. They are making a chain of implausible pseudoscientific claims, all of which would have to be simultaneously true for their product to work.

Rather than publishing compelling science in peer-reviewed journals, they have decided to market their product with their unsubstantiated claims directly to the public through multi-level marketing.

False Skepticism

After Harriet’s original article about ASEA we received an e-mail at SBM from someone assuring us that ASEA is a legitimate product Just about every red flag, logical fallacy, and snake-oil talking point is present in this e-mail. They write:

I was on your site Science-Based Medicine and I read the article published by Harriet about Asea. I completely understand your skeptisism – I was also there. I have a B.Sc. in microbiology. When my mother came to me singing the praises of Asea, I was nothing but skeptic. I did my research to prove it as a placebo hoax. I realize how Asea looks to the scientific community but I tell you – the research and properly published results are coming. I promise you – this is no hoax – this is the future.

The “I was a skeptic, but now I believe” line is so common it’s a cliche.  The claim is meant to seem as if it were the overwhelming evidence that convinced the person, not predisposition. It’s an empty claim, for everything that follows demonstrates the person is anything but skeptical. Being a skeptic means more than just not believing immediately – it is a process of critical analysis and examination of scientific evidence and plausibility, all of which appears to be lacking here.

Future Evidence

The opening paragraph finishes with a promise that evidence is coming. This is also a very common claim. It is an argument from future vindication. There is, of course, no way to dispute this claim. By definition I am not privy to evidence that has yet to be published. It’s easy to make such claims, and it’s therefore an effective sales pitch, and can be made endlessly even if the studies never come.

In any case, it is dubious to make claims prior to the evidence. The promise of evidence isn’t enough, the evidence has to be evaluated and validated, that’s what peer review is for. Proponents of questionable health products and interventions, however, behave as if the purpose of scientific research is to confirm what they already know to be true, not to discover if it is true. They often say or imply, “We know it works, now we just need to prove it for those persnickety science types.”

The FDA Gambit

The e-mailer continues:

The first company which discovered the technology (Medical Discoveries Inc.) tried to have their product approved through the FDA for cystic fibrosis patients. They invested $29 million and ran out of money (they didn’t have the $100 million that most drugs cost to create and bring to market).

If they had decided to pursue drug approval through the FDA for the more than 200 indications they found Asea helped, they would have needed more than a billion dollars to invest and more than 10 years to get it to the people. Then the people could really complain about the price.

The FDA is often portrayed as an unfair obstacle to such products. It is true that it is expensive to get a drug through approval, but a product that has even the fraction of the potential that ASEA is purported to have would be worth the investment. Drug companies would be tripping over themselves to invest in such a product.

Further, the company would not have to get a separate indication for 200 separate conditions. To get a drug on the market you only need a single indication. The company could then only market to that one indication, but people and practitioners would be free to use it off label for any indication. If they really have 17 years of evidence for other indications, they could publish these studies to support such off label use. The “billion dollars” defense is simply absurd.

Good For What Ails Ya

One of the hallmarks of snakeoil is that it is apparently effective on a wide range of conditions, practically or sometimes literally every condition. We already see that the e-mailer is claiming the product works for more than 200 indications. They add:

When the current company, Asea, bought the intellectual property, they found in the research that this product helped pretty much every condition.

I have seen first hand how Asea works – that is the kicker – it really works on a 100% of people 100% of the time.

It is highly implausible that any treatment would be effective for so many different conditions, which have many different underlying causes. The second part of the claim above gives a clue as to how such an extraordinary belief comes about – the e-mailer is clearly relying heavily on anecdotal experience. If you rely upon subjective outcomes then placebo effects guarantee that you will come to believe the treatment works for everything. This claim is strong evidence not that the product works for everything, but the process of assessing the product is hopelessly flawed.

The related claim is that is works 100% of the time. I suppose this is meant to seem impressive – good sales copy. Actually it is a huge red flag that the claims are bogus. Nothing works 100% of the time in 100% of the people. Biology is too complex and variable for that to be plausible.

Multi-level Marketing

They continue:

They also decided on a direct sales model, it is a different method of distribution but definitely not a get rich quick scheme. They pay their associates for their marketing and advertising – it is a different method of inventory management. Word of mouth is a very powerful marketing tool when you have a product that can help many sick people but you are not permitted to state which types of illnesses it helps. Many negative stigmas exist about direct sales but Tupperware, Melaluca, Amway and Usana are all legal network marketing companies just like Asea.

That reads as it if is right out of a Multi-level marketing (MLM) recruiting brochure. MLM is basically a scam. Almost no one who gets involved makes money. Profits are usually seen only by those who start the companies or get in at the very top, not for the rank and file. It is a way of making your customers into a cheap sales force. Most people who sell some health supplement through MLM just make enough to support their own use of the product, or wind up with a garage full of cases of unsold product.

Argument from Popularity

It is just a matter of time until all embrace this technology. Asea is now in 14 countries with over 100,000 associates – that is a whole lot of placebo results… I promise you, at some point in all of your lives, you will take Asea. It is not an “if” product, it is a “when” product.

How could so many people be wrong? Because it’s human nature. The e-mailer implies that this many users (“associates” is a term for MLM sales people) could not all be based on placebo effects, but why? If they are also associates, then they have a motive to believe in and promote the product – hardly unbiased observers. But even if they were unbiased, that is the nature of placebo effects and anecdotal evidence. Millions or even billions of people can be falsely lead to believe that a worthless product is effective if they are basing it on subjective experience.

As an historical example, in the first quarter of the 20th century Dr. Albert Abrams was marketing his “electronic reactions” –  machines that used radio signal to diagnose and treat any illness. The claims are, for practical purposes, identical to those of Asea – treats anything, very popular, uses some new fangled technology in some proprietary process, etc. At its peak there were 3500 practitioners with millions of patient treated. It turns out that not only was the concept worthless, his machines did not even do what he claimed. Scientific American investigated and found they contained loose random machine parts.

But wait – how could millions of patient have been fooled by placebo effects?

They Laughed at Galileo

Penicillin was also laughed at when it was first introduced as a medicine. My, my how we have learned to depend on antibiotics. Asea is the next step.

I don’t remember anything about penicillin being laughed at. Perhaps the e-mailer read about “resistance to penicillin” and misunderstood. Even if true, this argument is worthless – and so common it is referred to as the “Galileo gambit.” The argument is that because some people who were criticized, dismissed, or laughed at in the past were later vindicated, that current people or claims that are also dismissed or derided will also later be vindicated.

Of course, most people who come out with fantastical scientific claims are cranks, not visionaries, and most extraordinary claims end up on the trash heap of scientific history. It is hindsight bias to look back and pick out the very few who were later shown to be right and argue that this is not only typical but is somehow evidence that any particular current claim will also be vindicated.

Big Pharma

Of course, no snake oil promoter can resist a swipe at “big pharma:”

Many big pharma companies were interested in buying the technology to shelve it – food for thought – healthy people are not good for the pharma sales.

So why didn’t they buy it? They certainly have the money.

But the real claim here is that pharmaceutical companies do not want drugs or products that actually cure people. They want to keep people sick to help boost sales. This is simply absurd. Any company who owned the right to an actual cure for anything would make a killing. Imagine a drug that can cure hundreds of conditions. Talk about a blockbuster.

Also – healthy people just live longer and eventually have more chronic conditions. Keeping people alive is good for business.

Conclusion

The real magic of MLM is that it can create customers who fervently believe marketing BS. The best way to get people to remember and believe something is to have them try to convince someone else of the same thing. It’s brilliant, actually.

Asea, however, is still a fantastical and unbelievable claim supported by nothing but hype, sales copy, and empty promises. It is salt water. The hand-waving nonsense about redox reactions is incoherent technobabble – the very essence of pseudoscience.

What would be convincing is published, peer-reviewed, independent, rigorous scientific studies with clear results. These don’t exist. No amount of distraction will change that fact.

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