From Abracadabra to Zombies
is a commentary on
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Honesty, law, and the free market
20 Dec 2009. On a recent Skeptic's Guide to the Universe podcast, there was a discussion of the legality of advertisements for homeopathic products that claim to cure AIDS, prevent malaria, and do other wonders. You'd think this topic would be treated the same way as, say, selling heroin to six-year-olds. Anyway, the non-discussion of legalizing harmful lying led to a discussion of whether it should be legal to sell homeopathic products in drugstores when major players in the game admit that such products are not "efficacious." In the U.S., homeopathy is not as big an item as it is in the UK, where homeopathic remedies are handed out by their National Health Service at taxpayers' expense. In a recent blog post, Dr. Ben Goldacre of Bad Science wrote about a UK government committee reviewing a decision that allows homeopathic products to make medical claims without evidence of efficacy. Several defenders of the decision lied about the evidence, but one, the head of Boots (a major pharmacy chain in the UK), was honest and admitted he had no reason to believe such products were "efficacious," but he sold them anyway because people want to buy them.
One view is to ban products that are known to be no more effective than a placebo. Another view is to allow the sale of such products, but inform potential buyers that they are about to spend good money on a sugar pill or drop of water that is packaged with a load of false claims about health benefits. A third view is to allow the sale of placebos labeled as whatever and let the buyer beware, as long as the claims fulfill current obligations regarding false and deceptive labeling and advertising. The SGU crew seems to favor the first position. Goldacre seems to favor the second. I favor the third.
I favor the third not because I'm a libertarian who believes the market should be free from any government interference. I am not a libertarian. I think the government should ban the sale of any over-the-counter health product that is known to be harmful if used according to the manufacturer's specifications. I don't think the government should be regulating every product that can be harmful if misused or intentionally abused. Only if the abuse is widespread and the danger serious should the government regulate sales.
I oppose banning the sale of homeopathic remedies because even if there is a reasonable line one can draw between products that are effective and products that aren't, that line shouldn't be drawn by the government. Furthermore, banning the sale of worthless remedies would empty most of the shelves in the pharmacy. The cold and flu remedy section would be nearly completely wiped out.
Americans spend $3 billion a year on cold remedies such as zinc lozenges, echinacea, Airborne, vitamin C, DayQuil, NyQuil, and other products despite strong evidence that they are not effective and have no measurable benefit against cold viruses or their symptoms. Antihistamines, decongestants, cough suppressants, and fever reducers do nothing to shorten the infection. Some even work against the healing process. Evolution Rx, William Meller, MD
The vitamin and mineral supplement area would have to be emptied. The detoxification and beauty products sections would have to go. There is no evidence that any of the thousands of such products do most buyers any good. Such products have their defenders and the debate would be endless regarding their "proven efficacy." If our government were in the business of providing worthless medicine to our citizens, I would be more sympathetic to a ban on such products, at least by our national health service (if we had one). I don't have as much of a problem with people wasting their own money as I do with them wasting some of mine.
In the weekly 3-page newspaper ad for my local CVC, a large pharmacy chain, more than 50% of the products offered are alcoholic beverages. Most of the other items listed and pictured are things like sodas, pizzas, ice cream, cashews, and candy. There are several food items listed, like eggs, milk, and orange juice. The only items listed that would be found in what might be loosely referred to as the pharmaceutical section are supplements of glucosamine/condroitin and coenzyme Q-10. The former has been shown to work no better than a placebo and the latter, while touted for many things, has been shown to reduce migraines but not much else. The evidence that coenzyme Q-10 reduces muscle pain caused by statins is very thin.
I oppose requiring complete honesty by law when selling snake oil because, while it's absurd to think pharmacists are voluntarily going to put up notices about the ineffectiveness of most of the products they sell, requiring them to do so would lead to more warning notices than safe and effective products. Furthermore, such notices might actually be noticed and make the customer wonder about a business that knowingly sells junk medical products. Why trust the other products to be what their labels say they are? Also, if a pharmacy is going to be honest, it will have to put notices on the vitamin and mineral supplement aisle that unless you have been diagnosed with a known deficiency, you will get no benefit from these products. You'd have to list which vitamins are toxic, how many people overdosed on them last year, and how many children died of an overdose of vitamin pills. You'd have to put a notice up next to the acetaminophen that it is the second leading cause of liver failure and report how many deaths it caused last year. And so on.
In the Google era, there is no excuse for anyone being uninformed about useless or harmful medicines. Everything you need to know about homeopathy and placebo medicine is at the tip of your fingers. People have a responsibility to wade through the literature. If they can't think critically and are persuaded that a sugar pill or drop of water can cure them of AIDS or prevent malaria, no law is going to save them from themselves.
Rather than legislate homeopathy out of business or demand honesty from pharmacies about the many products they sell, we'd do better to try to educate people. We should be encouraging the teaching of critical thinking in our schools, as the JREF is doing. We should continue with writing about the scientific evidence regarding homeopathy, vitamin supplements, etc. We should notify COSTCO, CVC, Rite Aid, Boots, and other pharmacies when products like Airborne are deemed useless and their manufacturers fined by the FTC. We might ask our pharmacists why they sell such products, and refuse to accept as an answer "because people buy them." People buy many illegal products, but that's not a sufficient justification for selling them. It may not do any good in most cases, but there may also be an occasional store manager with a conscience who will at least put Kevin Trudeau's latest book in an area that's hard to find.
Remember when laundry balls were the rage? A local business that sells filtered water was also selling these things. (I admit I once was naive enough to buy filtered water because I thought it tasted better than Davis, CA, tap water. Hey, even our City offices provide bottled water to their employees.) I mentioned to the owner that the Oregon attorney general had taken them off the market because they're worthless. The next time I visited the water shop, he wasn't selling laundry balls. I admit, however, that if my government were handing out laundry balls at the taxpayers' expense, claiming they would save the environment or cure AIDS, I would be first in line to sign the petition to make it illegal to sell them.
"Niceguy" Eddie of Nice Guy Eddie's Political Blog found fault with each of the three alternatives proposed above for dealing with ineffective products: the two discussed on the SGU podcast I'm responding to and my position that would “allow the sale of placebos labeled as whatever and let the buyer beware.” Eddie offers a fourth alternative, which I will try to paraphrase succinctly and accurately. Note: to keep it simple, I will use "effective" and "ineffective" from here on to mean "effective [or not] beyond the placebo effect."
Eddie: I don't think the average person is able to read and interpret information well enough to leave it up to the buyer to determine whether a product is effective. You think they can get whatever information they need on Google. So do I, but I don't think the average person is capable of separating the bunk from the credible information. I think the FDA should have the job of determining which products are effective and which are not. Only those that the FDA approves as effective should be allowed to be sold. In fact, I would go so far as to say: "I would outlaw the making of ANY MEDICAL CLAIM on ANY PRODUCT that has not passed FDA muster (or some idealized system that you are free to propose) for both efficacy and safety." Snake oil [i.e., ineffective products] would be allowed to be sold, but no medical claims can be made about such products either in labeling or in advertising.
reply: I should note at this point that it is already illegal to make false medical claims about products. Remember Airborne? The FTC fined the makers of that ineffective product $23,300,000 for claiming their vitamin and herb product could prevent and cure the common cold. So why is Airborne still stacked up in my local drug stores and COSTCO? Because now the producers of this ineffective product are not violating the law. Neither in its advertising nor on its labels is there a claim that the product cures or prevents the common cold. The manufacturer of this ineffective but legal product now makes claims like this: The key ingredients in Airborne have been shown to help support a healthy immune system as shown in scientific studies and medical journals. The producers of this ineffective product call it a dietary supplement and by doing so evade all the laws that apply to drugs under the governance of the FDA (as long as the product is not shown to be harmful, in which case, the FDA can step in). My point is that the snake oil salesmen will always be one step ahead of any governmental agency we put in charge of policing them. They don't have to make medical claims to get their point across.
I'm not averse to having the government put out consumer information that would include such reminders as: even though your immune system and your health in general depend on vitamins and minerals, unless you have been diagnosed with a specific deficiency, supplements are a waste of money. Supplements have no health value for most people. Most people get an adequate supply of nutrients in their daily diet. Six of the 13 vitamins you need can be toxic if taken in excessive quantities. Your body produces plenty of antioxidants and you will not benefit from antioxidant supplements of any kind. Furthermore, antioxidant supplements may do you harm by aggravating cancer cells and reducing longevity.
"This approach has several things going for it:
1) Better overall public health, particularly on a per-dollar-spent basis.
2) No more harm (as in your 'What’s the harm?' section) will be done, and yet this is accomplished without the need for increased safety/warning labeling.
3) Most (if not all) “Free market” principles still apply. [Fraud isn't protected by law and selling products that have been shown to be ineffective is fraudulent.]
I do realize that what I’m proposing is not practical, politically speaking. The special interests of the snake oil salesmen, just like every other form of magical thinking, hold far too much [power] in our government and over public policy making. (And I'm only talking about the US here! I realize that it's much worse in the UK with their libel laws!) But it’s the only system that I can see 'working,' especially in the 'Google age,' and it is therefore the only principled conclusion I can reach, given the ideals that I hold."
reply: Even without the special interests, there is a major problem with elected officials who have fallen in love with some form or other of snake oil and are hell-bent on making sure their favored ineffective or harmful "health" products and practices get the equivalent of favored-nation status. People like Sen. Harkin may mean well, but they do great harm to our health-care system when they promote acupuncture, homeopathy, chiropractic, natural cures, and so on. Some medical professionals would like to see these "alternative" professions legislated out of existence — a kind of Prohibition of Ineffective Health Practices.
Harmful medicine is a separate issue. I'm concerned in this blog entry only with the issue of ineffective medicine. I would note, however, that a product deemed effective and safe for one thing can be used for something else and that something else might prove harmful. So, you're not going to eliminate the potential for harm with your proposal. There's also the problem of what to do when the FDA says something is effective (and safe), there are no scientific studies to say otherwise, but anecdotes have been piling up for years that indicate something is amiss? This is the current situation regarding certain generic drugs. (See this NY Times article for more info.)
I'm not convinced the FDA or any other agency should have the power to determine what is and what is not effective beyond a placebo effect. I am convinced that even if the FDA had such power it would be easy to circumvent any regulations they might make. We've seen what has happened when a government agency fines or shuts down a Kevin Trudeau or producers of such products as Airborne, fuel enhancers, Slick 50, free energy machines, Q-Ray bracelets, Q-Link jewelry, the Quadro Tracker, etc. The results are not very encouraging. The hucksters repackage, retool, and reinvent themselves with new labels, new packaging, and new customers. Fraud is already illegal. Harmful products are regulated by many government agencies.
It's obvious that millions of people currently use ineffective health products and services, even though the scientific studies are out there for anyone to see that demonstrate that such things as acupuncture, homeopathy, chiropractic, naturopathy, herbal and supplement medicine, holistic medicine, energy medicine, and the like are not effective beyond a placebo effect for most of the things they treat. And for those who won't or can't read the scientific studies, there are other sources: skeptical and science-based websites and blogs, etc. I don't think it is because the average person isn't capable of understanding the information that prevents our debunking of ineffective medicine from having more of an effect on society in general. Many of the users and defenders of "alternative" medicine have a deep distrust of the government, of science and science-based medicine, of drug companies, and of anyone who defends science-based medicine. We might be able to prevent these people from getting their alternative products or services legally or in their own country, but you will not be able to force them to use science-based medicine.
I don't think it's impossible to determine that a health product or service is ineffective, but I don't think a crystal clear case can always be made. I think more benefit to society will come from letting the borderline cases be decided by the marketplace rather than by a government agency. A government agency is likely to follow the precautionary principle about products that seem effective for some people some of the time but not for most people most of the time. Remember, we're not talking safety here, we're talking effectiveness. It's my body and I don't want some government bureaucrat telling me that I can't buy a product because studies have been producing conflicting results and he's not sure the product is effective. Some scientists say it is; others say it isn't. Let me decide. If I'm wrong, no harm done. If the government's wrong, some benefit may be denied me, not to mention the benefit denied to those making, distributing, and selling the product I want to buy.
In any case, I don't think we need fear your proposal going into effect any time soon. A greater and more imminent danger is that some influential Senators and Congressmen will succeed in making the government pay for ineffective medical services and products. Now we're talking about some of my money being used to subsidize quackery. This is not a free-market issue so much as it is a government-waste issue. I'm against government waste and support all legislation that would prohibit using taxpayer money to provide ineffective health products and services. If my neighbor wants to overdose on homeopathic sleeping pills, let him. It's his money and I don't like him anyway.
Niceguy Eddie's response:
The irony was not lost on me that you paraphrased my original email and, expecting to not have much to say about it (at least according to your email,) went on to write a response at least twice as long as my original (admittedly wordy) letter. LOL. Oh well. I'm happy to have provided such food for thought! :)
There's just two points that I don't think were clearly made - and it's possible that I hadn't been clear enough in my original letter. They don't really change anything from a skeptic's standpoint, but I think some clarification is needed...
1) While we both agree that information can be found on Google, in my experience Google is a far more effective way of disseminating bad information than it is for finding good information. And it's more than just that the average (and sometimes even exceptional) Joe may not know the difference. Chances are, "Google" is where they found their 'woo' in the first place! It's as much part of the problem as part of the solution. ("Google," I'm assuming BTW, is just a metaphor for the Internet. I wouldn't want people to think I owned stock in "Yahoo!" or something.)
2) I did mention the FDA as a possible testing body for any and all medical claims, but I think it's quite an exaggeration to paraphrase what I was saying down to "I think the FDA should have the job of determining which products are effective and which are not." That's WAY more of a declaration of faith than I'm willing to make in the FDA as it stands now!
I only mentioned the FDA because they were a conveniently available, existing example of what I was proposing. You are certainly right that the FDA can and has been politicized. So... yeah: there would be issues within the agency that would need to be addressed. Or, if you prefer, we can scrap the whole thing and design the perfect system / body for testing these claims for market approval from the ground up. I just figured my email at the time was already getting too long, so no sense trying to fix ALL the world's problems in one go. :) In any case, while I do believe that having certain controls and procedures and a certain amount of openness with the documentation as part of the public record can prevent a lot of the political and corporate tampering, I am well aware that the current incarnation of the FDA is far from perfect in this regard. (It made me cringe a bit the way it sounded like I was making a ringing endorsement of the FDA!) Also - defining all of these would end up running WAAY longer than I'm willing to put in for at the moment, and be way off-topic besides.
All in all though, I enjoyed reading your response, and appreciate you including my [albeit paraphrased] comments. (And thanks for the LINK back!) I'll probably include a link to that (12/17) page, along with my original email in my blog at some point in the near future because, as you've stated, there are a lot of issues in play here: Public safety, public health/tax dollars, free speech, free market, what agency of body has what role or responsibility... Lot's of good stuff to mull over, talk about, argue about... It could definitely get interesting.
Thanks again, Niceguy Eddie
reply: Yep, I think this may be one of those roads that never ends or ends by spiraling back on itself.
update: 21 Jan 2010. Science-Based Pharmacy reports that the Ontario College of Pharmacists has prohibited Ontario pharmacies from selling health products that are not approved for safety and efficacy by Health Canada.