Every now and then the makers of quack medical products and other woo-woo snake oil nonsense get a well deserved smack down. The makers of the Q-Ray Ionized Bracelet, which I’ve written about previously here, got one back in September of 2006 when the FTC sued them for fraud and the court ruled in the FTC’s favor. The makers of the Q-Ray Bracelet filed an appeal and the results of that case were just announced yesterday (PDF file). Here’s a sample:
EASTERBROOK, Chief Judge. WIRED Magazine recently put the Q-Ray Ionized Bracelet on its list of the top ten Snake-Oil Gadgets. See http://blog.wired.com/gadgets/2007/11/10-awesome-gadg.html.
The Federal Trade Commission has an even less honorable title for the bracelet’s promotional campaign: fraud. In this action under 15 U.S.C. §§ 45(a), 52, 53, a magistrate judge, presiding by the parties’ consent, concluded after a bench trial that the bracelet’s promotion has been thoroughly dishonest. The court enjoined the promotional claims and required defendants to disgorge some $16 million (plus interest) for the FTC to distribute to consumers who have been taken in. 448 F. Supp. 2d 908 (N.D. Ill. 2006), modified in part by 472 F. Supp. 2d 990 (N.D. Ill. 2007).
According to the district court’s findings, almost everything that defendants have said about the bracelet is false. Here are some highlights:
- Defendants promoted the bracelet as a miraculous cure for chronic pain, but it has no therapeutic effect.
- Defendants told consumers that claims of “immediate, significant or complete pain relief” had been “test-proven”; they hadn’t.
- The bracelet does not emit “Q-Rays” (there are no such things) and is not ionized (the bracelet is an electric conductor, and any net charge dissipates swiftly). The bracelet’s chief promoter chose these labels because they are simple and easily remembered—and because Polaroid Corp. blocked him from calling the bangle “polarized”.
- The bracelet is touted as “enhancing the flow of bio-energy” or “balancing the flow of positive and negative energies”; these empty phrases have no connection to any medical or scientific effect. Every other claim made about the mechanism of the bracelet’s therapeutic effect likewise is techno-babble.
- Defendants represented that the therapeutic effect wears off in a year or two, despite knowing that the bracelet’s properties do not change. This assertion is designed to lead customers to buy new bracelets. Likewise the false statement that the bracelet has a “memory cycle specific to each individual wearer” so that only the bracelet’s original wearer can experience pain relief is designed to increase sales by eliminating the second-hand market and “explaining” the otherwise-embarrassing fact that the buyer’s friends and neighbors can’t perceive any effect.
- Even statements about the bracelet’s physical composition are false. It is sold in “gold” and “silver” varieties but is made of brass.
The magistrate judge did not commit a clear error, or abuse his discretion, in concluding that the defendants set out to bilk unsophisticated persons who found themselves in pain from arthritis and other chronic conditions.
It doesn’t get much clearer than that. The court agrees with the FTC that the product is bullshit and that every claim made about it is an outright lie. What do the lawyers for Q-Ray have to say? Well, they think the judge was being unfair::
Defendants maintain that the magistrate judge subjected their statements to an excessively rigorous standard of proof. Some passages in the opinion could be read to imply that any statement about a product’s therapeutic effects must be deemed false unless the claim has been verified in a placebo-controlled, double-blind study: that is, a study in which some persons are given the product whose effects are being investigated while others are given a placebo (with the allocation made at random), and neither the person who distributes the product nor the person who measures the effects knows which received the real product. Such studies are expensive, not only because of the need for placebos and keeping the experimenters in the dark, but also because they require large numbers of participants to achieve statistically significant results. Defendants observe that requiring vendors to bear such heavy costs may keep useful products off the market (this has been a problem for drugs that are subject to the FDA’s testing protocols) and prevent vendors from making truthful statements that will help consumers locate products that will do them good.
“But it costs money to prove our products actually do what we claim they do! How can you expect us to maintain our absurd profit margins if we have to show our products work!?” This next bit contains an important point which I think a lot of folks don’t realize so I’m going to underline them for you:
Nothing in the Federal Trade Commission Act, the foundation of this litigation, requires placebo-controlled, double-blind studies. The Act forbids false and misleading statements, and a statement that is plausible but has not been tested in the most reliable way cannot be condemned out of hand. The burden is on the Commission to prove that the statements are false. (This is one way in which the Federal Trade Commission Act differs from the Food and Drug Act.) Think about the seller of an adhesive bandage treated with a disinfectant such as iodine. The seller does not need to conduct tests before asserting that this product reduces the risk of infection from cuts. The bandage keeps foreign materials out of the cuts and kills some bacteria. It may be debatable how much the risk of infection falls, but the direction of the effect would be known, and the claim could not be condemned as false. Placebo-controlled, double-blind testing is not a legal requirement for consumer products.
Did you get that? Most medical products sold that are covered by the FTC (read: that aren’t drugs) are not required to undergo placebo-controlled double blind tests to prove their claims. Any testing done is not only at the whim of the company, but the methodology can be whatever the hell they want it to be. This is as true for so-called “herbal supplements” and “homeopathic remedies” as it is for craptastic medical devices. If it ain’t a drug (and even if it is, but that’s a different discussion for another time) then you should skeptically consider any claims of “clinically proven” or “proven in studies” made in an advertisement.
This is why everyone needs at least a basic amount of scientific literacy. We get bombarded with claims of miracle cures constantly and the government isn’t going to stop them until they’ve made enough money and gotten enough pissed off consumers to complain that the FTC considers it enough of a problem to do something about it. I get emails from people trying to defend these companies all the time that all say the same thing: “Well they wouldn’t be allowed to sell it if it didn’t work.”
Bzzt! Wrong! Thanks for playing, but you’re a complete idiot! They can sell it for years before action might be taken against them and even then it could take awhile before anything happens. The Q-Ray Bracelet has been around for the better part of a decade and when the FTC first turned its eyes towards them the makers simply changed their commercials to remove any specific claims about what the bracelet does. It featured a lot of people standing around talking about how when they first put it on they could instantly feel a difference (difference in what?) and how they felt better and more energized since they started wearing the bracelet (which means what exactly?) and that was enough to buy them a few more years. Even after losing the lawsuit in 2006 it’s taken over a year for the appeals court to uphold it and guess who’s been selling bracelets the entire time? The best defense against getting ripped off by bogus medical claims is to have enough science under your belt to smell the bullshit being shoveled your way.
Still, reading the comments of the judge in this case, who wasn’t buying the argument at all, does a lot to warm the heart:
But how could this conclusion assist defendants? In our example the therapeutic claim is based on scientific principles. For the Q-Ray Ionized Bracelet, by contrast, all statements about how the product works—Q-Rays, ionization, enhancing the flow of bio-energy, and the like—are blather. Defendants might as well have said: “Beneficent creatures from the 17th Dimension use this bracelet as a beacon to locate people who need pain relief, and whisk them off to their homeworld every night to provide help in ways unknown to our science.”
Not that the lawyers didn’t try to prove the bracelets work, but when you see what they were claiming as the basis of their proof, well, if you’re like me then you’ll probably laugh out loud and scare your coworkers and/or family members:
To this defendants respond that one study shows that the Q-Ray Ionized Bracelet does reduce pain. This study, which the district court’s opinion describes in detail, compared the effects of “active” and “inactive” bracelets (defendants told the experimenter which was which), with the “inactive” bracelet serving as a control. The study found that both “active” and “inactive” bracelets had a modest—and identical—effect on patients’ reported levels of pain. In other words, the Q-Ray Ionized Bracelet exhibits the placebo effect. Like a sugar pill, it alleviates symptoms even though there is no apparent medical reason. … Defendants insist that the placebo effect vindicates their claims, even though they are false—indeed, especially because they are false, as the placebo effect depends on deceit. Tell the patient that the pill contains nothing but sugar, and there is no pain relief; tell him (falsely) that it contains a powerful analgesic, and the perceived level of pain falls. A product that confers this benefit cannot be excluded from the market, defendants insist, just because they told the lies necessary to bring the effect about.
Isn’t that amazing? The lawyers for the Q-Ray Ionized Bracelet have admitted under oath in a court of law that the product is no more effective than swallowing a sugar pill at relieving pain and, this is the really good part, they had to lie about its benefits otherwise there would’ve been no benefit at all. So the product does work, at least somewhat, and our lies were justified because they make the product work!
As a side note: Those few idiots who still send me emails occasionally telling me that I have no proof that the Q-Ray Ionized Bracelet is complete bullshit can stop sending those emails now. The lawyers have fessed up in court to the truth.
The appeals judges apparently weren’t completely unsympathetic to the argument that the placebo effect is of some use to some people, but that wasn’t enough to justify the defendants in this case. The following quotation is quite lengthy, but it does an excellent point of answering the placebo effect argument:
Yet the Federal Trade Commission Act condemns material falsehoods in promoting consumer products; the statute lacks an exception for “beneficial deceit.” We appreciate the possibility that a vague claim—along the lines of “this bracelet will reduce your pain without the side effects of drugs”—could be rendered true by the placebo effect. To this extent we are skeptical about language in FTC v. Pantron I Corp., 33 F.3d 1088 (9th Cir. 1994), suggesting that placebo effects always are worthless to consumers. But our defendants advanced claims beyond those that could be supported by a placebo effect. They made statements about Q-Rays, ionization, and bio-energy that they knew to be poppycock; they stated that the bracelet remembers its first owner and won’t work for anyone else; the list is extensive.
One important reason for requiring truth is so that competition in the market will lead to appropriate prices. Selling brass as gold harms consumers independent of any effect on pain. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is represented as a miracle cure but works no better than a dummy pill is a form of fraud. That’s not all. A placebo is necessary when scientists are searching for the marginal effect of a new drug or device, but once the study is over a reputable professional will recommend whatever works best.
Medicine aims to do better than the placebo effect, which any medieval physician could achieve by draining off a little of the patient’s blood. If no one knows how to cure or ameliorate a given condition, then a placebo is the best thing going. Far better a placebo that causes no harm (the Q-Ray Ionized Bracelet is inert) than the sort of nostrums peddled from the back of a wagon 100 years ago and based on alcohol, opium, and wormwood. But if a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer. See Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992) (a statement violates the FTC Act “if it is likely to mislead consumers, acting reasonably under the circumstances, in a material respect”).
Physicians know how to treat pain. Why pay $200 for a Q-Ray Ionized Bracelet when you can get relief from an aspirin tablet that costs 1¢? Some painful conditions do not respond to analgesics (or the stronger drugs in the pharmacopeia) or to surgery, but it does not follow that a placebo at any price is better. Deceit such as the tall tales that defendants told about the Q-Ray Ionized Bracelet will lead some consumers to avoid treatments that cost less and do more; the lies will lead others to pay too much for pain relief or otherwise interfere with the matching of remedies to medical conditions. That’s why the placebo effect cannot justify fraud in promoting a product.
Well said I thought. It’s worth reading the whole document as the discussion on the remedy—the makers of Q-Ray have to forfeit $16 million plus interest in profits back to consumers—as it includes decisions on objections raised by the company to the terms and reveals just how dishonest they are. In particular is the fact that if you bought a bracelet by phone you had 30 days to get you money back, but if you bought it through their website (which the infomercial heavily encouraged you to do) then you only got 10 days for a refund.