Archive for the ‘science’ Category

POM Wonderful and Hearts vs Brains

The makers of POM Wonderful want you to use your heart, not your brain.

At least, that’s the distinct impression we get from the company’s recent battle with the US Federal Trade Commission. Last week, an administrative law judge for the FTC found that at least some of POM’s ads made “false and misleading” claims about the health benefits of the trendy, branded pomegranate juice. And the company is fighting back with a series of ads that, by quoting the judge out of context, makes it look like he actually looked favourably upon their product.

The tagline for these ads: “FTC v. POM: You be the judge”.

So POM wants you to be the judge. On the surface, that sounds like they want you to think for yourself. And who could complain about that? But context matters. So when the company is pushing back against the FTC’s assertion (and the court’s finding) that the health claims made on behalf of its juice just don’t stand up to scientific scrutiny, the implied message is that yes, you the consumer should decide, but you shouldn’t use your head in doing so. After all, if you used your head and thought it through rationally, you would want to look at the evidence. And, well, the evidence doesn’t look so good for POM. But the makers of POM, it seems, would rather you look inward instead of looking at the evidence. C’mon, you’ve tasted it. It’s delicious. It must be good for you. And you, dear customer, are smart enough to know that, right? Forget what the science says.

This kind of thing is arguably part of a larger social trend. See this recent essay by Joseph Heath and Andrew Potter, on the way politicians, in particular over the last decade, have found new ways to play fast-and-loose with the truth. Heath and Potter point out the new popularity of the trick of using stubborn repetition as means of bullying your way past awkward facts. A lie can be convincing, in particular when it feels right, when the claim being made fits with your world view or how you want the world to be. And who wouldn’t like to believe that a tasty serving of fruit juice could prevent heart disease or cancer?

The makers of POM are certainly not unique among advertisers wanting you to use your heart, rather than your brain. But they are unusually bold about it, going on the offensive and thumbing their noses at the people whose job it is to do the fact-checking. So consumers beware: when a company wants you not to take a hard look at the facts, it’s usually time to do just that.

Stem Cell Fraud

Stem cell science is pretty sexy. And as the saying goes, “sex sells.” And if something sells, someone is liable to make a buck off it, whether it’s right to do so or not.

See this opinion piece (in The Scientist) by Zubin Master and David B. Resnik: Reforming Stem Cell Tourism.

As with many new areas of technological advancements, stem cell research has received its fair share of hype. Though much of the excitement is warranted, and the potential of stem cells promising, many have used that hype for their own monetary gain. … Young and elderly patients have died from receiving illegitimate stem cell treatments; others have developed tumors following stem cell transplantations….

Master and Resnik point to the need for patient education, and to the limits of international guidelines, but their main focus is on the ethical responsibilities of scientists — including the responsibility not to cooperate in various indirect ways with unscrupulous colleagues. (It is very, very hard to do clinical science in a vacuum, and so isolating unscrupulous scientists may be one way to put them out of business.)

But it’s important to point out that this is as much a story of business ethics as it is of scientific ethics. The unscrupulous individuals preying upon the sick aren’t doing it for free. What these clinics are doing is committing fraud, and endangering their customers in the process.

Now there’s nothing ethically subtle about that. You don’t need a Ph.D. in philosophy to know that fraud is bad. But there’s another, subtler, issue here, namely an underlying theme about the general lack of scientific literacy on the part of consumers and the ability of business to use it to their advantage. Companies of all kinds can do a lot of good in the world by promoting scientific literacy, and by being scrupulously careful about having the facts straight when they present their products to consumers and tell them, “this works.”

Now of course, we’re never going to prevent such behaviour entirely. As long as there are desperate people in the world, there will be snake-oil salesmen eager to make a buck from their misery. But as Master and Resnik suggest, that doesn’t mean we shouldn’t try.

Winning the Hearts and Minds of Organic Consumers

The agri-food business has rapidly become one of the most ethically-controversial on the planet. Vicious cultural battles are being fought over what constitutes an ethically-decent way to raise various food products. And marketers are fighting tooth-and-claw to develop and market food products that meet the increasingly diverse desires of consumers — including consumers who may want food that is not just low-fat, low-salt, and low-cal, but organic, free-range, local, low-carbon, cruelty-free, fair-trade and/or free of genetically-modified ingredients. Winning the hearts and minds of a public with such varied preferences and interests is no easy task.

For a peek at the cultural and ethical complexity of the agri-food industry, check out this story, by Louise Gray, writing for The Telegraph: Soil Association ditches rockstars to go back to its roots. The story is really a profile of Helen Browning, the new director of the UK’s Soil Association, which is the nation’s most significant pro-organic charity, as well as the organization responsible for the world’s very first certification system for organic food back in the 60’s.

Two key points are worth making, here:

1) Browning displays an unusual degree of common sense in avoiding an “us vs. them” attitude towards non-organic farmers:

Much to the dismay of the more ‘fundamentalist’ wing of the organic movement she is also relaxed about letting non-organic farmers join the organisation and sharing information with intensive agriculture….

This is essential, if advocates of organic farming really are concerned with the health of consumers and the planet, rather than merely being concerned with promoting the organic ‘brand.’ Turning organic agriculture into an all-or-nothing category makes it too much like a cult, alienating non-organic farmers and giving them little reason to try to learn about alternatives or to reduce the amount of pesticides they use.

2) On the other hand, Browning’s hit-and-miss attention to science is are sure to do damage to her cause.

The former chair of the food ethics council argues that large scale units are overusing antibiotics and creating MRSA strains that are a danger to humans as well as animals.

She uses homeopathy to keep her herd healthy, but mostly it is being outdoors on a mixture of grass and clover that makes happy cows and tasty beef….

This is rather alarming. While Browning is right to worry about overuse of antibiotics in agriculture — that’s a serious public-health risk — opting for homeopathy as an alternative is utter lunacy, roughly equivalent to relying on witchcraft. (The Soil Association’s standards for organic livestock do permit standard vaccination, but also promotes the use of homeopathy.) Where the health of food animals is concerned, we need proven methods, not dis-proven ones. Consider: any food-processing plant that relied exclusively on, say, prayer or the blessings of a priest to eliminate germs, instead of thoroughly cleaning their machines, would face the wrath of regulators, not to mention public outrage. If organic agri-business is to win not just hearts, but also minds, it needs to do a better job of relying on science, and not just wishful thinking.

Profiting from Customers’ False Beliefs

Is it ethical for a business to profit from its customers’ false beliefs? Or, more to the point, is it ethical to profit from your customers’ beliefs when you think those beliefs are false? What if you encourage those beliefs?

Case in point: a number of businesses have sprung up to take advantage of the fact that a number of fundamentalist Christians believe that May 21, 2011 (i.e., tomorrow) is the day on which “The Rapture” will happen, which will involve the return to earth of Jesus Christ, the rescue of believers, and the start of a process culminating in the destruction of the world in October. Enter the profit-seeking atheists. Eternal Earth-Bound Pets, for example, will guarantee (for just $135) to come to a believer’s house, post-rapture, to rescue their pets. Salvation, after all, is for human believers only, so the faithful “know” that atheists and animals will be left behind. (For more details, and more examples, see this item from ABC News: May 21, 2011: Profiting on Doomsday?)

Profiting from this particular set of false (i.e., unsupported) beliefs seems, frankly, pretty innocuous. Those who hold such beliefs are few, and are liable to be mocked by the vast majority of Christians, who scoff at the idea that the exact date of the Rapture can be determined so precisely. When the Rapture ends up not happening (and I realize I’m going out on a limb, there) those who ponied up for the “service” offered by Eternal Earth-Bound Pets will be out $135, but other than that they’ll be no worse for wear. But what about other examples?

Let’s start with a fictional example to test our intuitions. What if I find out that you believe, for whatever reason, and despite the fact that you live far from any indigenous populations of elephants, that your rose garden is in imminent danger of being trampled by elephants. And let’s say you also believe (for whatever reason) that elephants are deterred by he sound of the revving of a Porsche engine. Am I justified in selling you a Porsche that you do not otherwise need, and that perhaps you cannot truly afford? Would that be predatory? Your belief, here, is clearly a crazy belief, and my profiting from your delusion seems not-quite-right. But then, as far as you’re concerned, I’m genuinely helping you. On the other hand, what if the reason you have that delusional belief in the first place is that I’ve convinced you of it?

Next, let’s get back to real-life examples. But let’s look at one that doesn’t revolve around a single event, like Rapture insurance does. What about, for example, selling homeopathy? Now, it’s one thing for a homeopath to prescribe and sell homeopathic treatments. After all, the homeopath presumably believes that such remedies work, in spite of the lack of evidence for that belief. Now, that belief itself might be culpable — if you’re going to sell a product, then ethically you ought to do what you can to make sure it really works — but at least the homeopath is selling in good (if misguided) faith. What about when licensed Pharmacists, people with the training to know perfectly well that homeopathic treatments cannot possibly work, sell them? That happens all the time. Shoppers Drug Mart, for example — Canada’s largest pharmacy chain — sells homeopathic treatments, and all the franchisees of that chain are required to be licensed Pharmacists. That is, they are people whose scientific training tells them that such remedies have zero scientific credibility. So they, too, are profiting from their customers’ false* beliefs — beliefs that they, the sellers, know to be false. Of course, the difference between selling homeopathy and selling Rapture insurance is that in the case of homeopathy, people’s lives really might be at stake.

Information is crucial to the efficient operation of a free market. Asymmetries of information constitute an entire category of situations in which economists will tell you market failures are liable to occur. Knowledge, alas, can never be perfect. So what we instead insist on is that transactions at least be made in good faith. It’s clear that that means the consumer needs to have enough information to know that the product she is about to buy will satisfy her desires; what’s less clear is whether the consumer must also know enough to know whether the product will satisfy her needs.

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*Note: some of you may want to quibble with my use of the word “false” to refer to beliefs in either a) the Rapture or b) homeopathy. You may point out that saying that there’s a lack of evidence for a particular belief isn’t the same as saying that that belief is false. That’s technically true. But when a belief is implausible on the face of it, is unsupported by evidence, and conflicts with a great number of beliefs that are well-supported by evidence, it is entirely reasonable to call it “false.” At least until the Rapture.

Insider Trading at the FDA

A scientist employed by the US Food and Drug Administration has been arrested and charged with insider trading.

Here’s the story, from Diana B. Henriques at the New York Times: U.S. Chemist Is Charged With Insider Stock Trades

A 15-year veteran of the federal Food and Drug Administration and his 25-year-old son were arrested on Tuesday and charged with systematically using confidential information about pending drug applications to reap millions in illegal trading profits since 2007.

As part of its drug-approval process, the FDA is given sensitive information by companies seeking such approval. And the status of a company’s application within the FDA’s own decision-making is itself sensitive information. Since FDA approval is essential to getting a drug to market, the announcement that a company’s drug has been granted, or denied, approval by the FDA can have a huge impact on the value of a company’s stock. And what FDA chemist Cheng Yi Liang did is to use information available only to FDA insiders to make profitable trades on the stock of companies then seeking FDA approval.

Just what was so wrong with what went on here?

In a statement announcing the case, Lanny A. Breuer, the assistant attorney general for the criminal division, said: “Cheng Yi Liang was entrusted with privileged information to perform his job of ensuring the health and safety of his fellow citizens. According to the complaint, he and his son repeatedly violated that trust to line their own pockets.”

Now Mr Breuer is clearly engaging in a bit of prosecutorial rhetoric. He’s right of course that Cheng Yi Liang was entrusted with privileged information, but there’s no obvious reason to think that his use of that information for personal gain jeopardized anyone’s health or safety. But fair enough: Mr Breuer is playing his role in an adversarial system, and that licenses a certain amount of hyperbole.

But what really is wrong with the kind of insider trading that Cheng Yi Liang engaged in? The precise worry about insider trading is the subject of some debate, and I’ve blogged about that before. (See: Ethics of Insider Trading.)

There are several ways we could get at just what was unethical about what Cheng Yi Liang did. One worry is that he profited unjustly, gaining money that he didn’t earn and had no right to. Also, in engaging in insider trading, he traded on information not accessible to others. That means that the people he traded with were at an unfair advantage, and likely lost money as a result. It also means that, subject as it was to significant information asymmetries, the market in which he traded was rendered slightly less efficient, as a whole.

There is of course another ethical worry: if chemists working for the FDA take a personal financial interest in the fate of various approvals, that could quite easily corrupt the work they do. In other words, it puts such a chemist into a conflict of interest. In a conflict of interest, what is fundamentally at stake is our trust in an individual’s judgment. If FDA scientists have a personal stake in their scientific work, then we have reason to doubt their judgment. And, worse, if the judgment of FDA scientists becomes subject to doubt, then the public ends up having a reason (though perhaps not a sufficient reason) to doubt the work of the FDA as a whole.

Unethical Herbal Supplements

Hey, what’s in that bottle of all-natural herbal supplements on your kitchen counter? Are you sure? What will those supplements do for you? Cure all that ails you? Something? Nothing? One way or the other, how do you know? The truth is, you probably shouldn’t feel so certain.

Here’s the story, from Katherine Harmon, in Scientific American: Herbal Supplement Sellers Dispense Dangerous Advice, False Claims

[The lack of evidence for their effectiveness] …hasn’t stopped many supplement sellers from making the false claims and even recommending potentially dangerous uses of the products to customers, according to a recent investigation conducted by the Government Accountability Office (GAO). To obtain a sample of sales practices, the agency got staff members to call online retailers and to pose undercover as elderly customers at stores selling supplements.

Customers were not only told that supplements were capable of results for which there is no scientific evidence (such as preventing or curing Alzheimer’s disease); the advice and information also was potentially harmful (including a recommendation to replace prescription medicine with garlic)….

Some fans of herbal remedies are liable to complain that the relevant government agencies ought to be directing their efforts at the real culprits, namely Big Pharma. Why pick on people who package and sell “natural” herbal products when major pharmaceutical companies are, on a regular basis, found to have engaged in a whole range of dubious and sometimes deadly behaviours? But that’s roughly like a bank robber, upon his arrest, complaining that the cops ought to be out chasing white-collar criminals instead. The fact that embezzlement is a bad thing does nothing to diminish the badness of robbery. Both are wrong, and both are worthy of punishment.

Essentially, what we’re seeing here is history catching up with the makers of herbal supplements. Over the last decades, we’ve imposed increasingly tough rules on the pharmaceutical industry (though those rules still need to be tightened up in various ways). But herbal products are part of the “natural” products industry, and that industry is woefully under-regulated. Indeed, that industry is probably about as well-regulated today as the pharmaceutical industry was, say, 50 years ago.

(p.s. for information about which herbal supplements are and are not backed by good science, see Scott Gavura’s Science-Based Pharmacy blog.)

Pharmacists and Candour About Homeopathy

If someone selling something believes that it doesn’t work, should they tell you so? Does it matter if the person doing the selling is a licensed professional, someone with advanced training and a sworn duty to promote the public good?

From the BBC: New guidance for homeopathy use

The regulatory body for pharmacists in NI [Northern Ireland] has proposed that patients be told that homeopathic products do not work, other than having a placebo effect.

The draft guidance comes following a report on homeopathy published earlier this year by the House of Commons Science committee.

It reviewed the evidence base for homeopathy and concluded that it was “not an efficacious form of treatment”….

Of course, some people believe — despite the best available evidence — that homeopathy really works. But pharmacists (being educated in the scientific evaluation of evidence) generally do not. And as professionals, they have an obligation not just to be honest with customers about that, but indeed to be candid about it.

Here is the Code of Ethics for the Pharmaceutical Society of Northern Ireland. The Code calls upon Pharmacists to “Maintain public trust and confidence in [their] profession by acting with honesty, integrity and professionalism”. That’s pretty vague, so applying it requires interpretation. And in the literature on professional ethics, the argument is usually that what we need from professionals like Pharmacists is not just old-fashioned honesty, but candour. Why? Because mere honesty really just boils down to telling the truth when someone asks you a question. And that’s a very good start, of course. But in many situations — the kinds of situations where we turn to professionals for help — we often don’t know the right question to ask. So we rely on the professionals to be candid; in other words, we rely on them to be open and forthright, and to volunteer information that they think we would want and/or need. And health products are among the most difficult for consumers to understand. So, it’s not at all surprising that the professional body in this case advised its members to be candid with the consuming public about the lack of evidence in support of homeopathy. In fact, it’s barely even commendable, given that candour about such things is a basic professional responsibility.

Should Consumers Trust Big Pharma?

Lots of people don’t trust Big Pharma. And to a significant extent, that’s for good reasons. (I’ve blogged about some of those reasons here, here, here, here, here, here, here and here, just to cite a few examples. See also some of the entries on the other blog I co-author, the Research Ethics Blog.)

Trust in big pharma is an important issue. Pharmaceuticals are responsible for saving and improving a huge number of lives. Vaccines alone have prevented literally millions of deaths. Survival rates for many cancers are better than they used to be. And AIDS, once a death sentence, is now regarded as a chronic disease. So there’s real benefit from pharma, but also an undeniable track record of scandals and general unethical behaviour. What should we think?

The first thing worth noting is that the question in the title above is vastly oversimplified. The question isn’t “should consumers trust big pharma?”, it’s more like “To what extent, and under what circumstances, on what issues, should consumers trust big pharma?”

Setting aside the industry’s spotty track record, the main reason people tend not to think Big Pharma trustworthy is, of course, the fact that Big Pharma consists of profit-oriented organizations. And the general assumption is that money corrupts. Of course, money isn’t the only thing that corrupts judgment (so does love, reputation, ideology, etc etc), and big pharma is far from the only industry where big money is at stake. But still, there’s a real worry here (one I’ve blogged about before).

Now, what about the reasons in favour of trusting Big Pharma? What factors would tend to make Big Pharma trustworthy, to at least some extent?

Now I cannot emphasize this strongly enough: what follows is not intended to imply a general conclusion about the trustworthiness of Big Pharma. It’s just a list of important factors to keep in mind when assessing the trustworthiness of a particular claim, by a particular company, on a particular issue.

1) Ethics. Don’t just think about the organizations; think about the people who work at them. They’re mostly people like you & me. Most of them got into the business to try to help people (and, yeah, to make a living). And most of them were raised by their parents to be decent, honest folks. Most people tell the truth about most things most of the time.

2) Regulation. The pharmaceutical industry is heavily regulated, subject to lots of laws regarding the efficacy and safety of their products, as well as regarding advertising. Criminal and civil sanctions are possible when pharma companies misbehave. Now, that’s not to say that the current level of regulation is sufficient, or that enforcement is adequate. But companies (and individuals) have been subject to serious sanctions. Companies generally want to stay out of court, and so they’ve got a reason — not always a sufficient reason, but a reason — to behave in a trustworthy manner.

3) Peer Review. In few other industries is fundamental information about what makes your product work (or not work) open to public scrutiny. In order for a new drug to receive approval to be marketed, it has to show itself to be safe and effective in clinical trials, and the results and methods of those trials have to be published in peer-reviewed medical journals. Drug companies are not allowed to make claims based on secret data. “Peer reviewed” means that the articles reporting on the trials have to be vetted by a panel of qualified experts if they are ever going to see the light of day. It’s an imperfect system (all systems relying on human judgment are) but bad science tends to get weeded out pretty quickly. Then, once a study is published, it’s there for assessment, and potentially criticism and rebuttal, by hundreds or thousands of other experts.

4) Scientific Overlap. You sometimes hear it implied that physician-researchers (the ones who do most clinical research, as well as doing all that peer reviewing mentioned above) have all been corrupted by corporate money. And it’s true that there really is cause for worry here. Too many docs get too much money (and other perks) from pharma, and are insufficiently transparent about that. So: it’s good to worry…up to a point. Here’s the problem with the pharma-controls-everything theory. Physician-researchers publish in scientific journals that are read not just by other physicians (some of whom don’t have industry funding), but also by biologists, chemists, epidemiologists, statisticians, and so on, most of whom have no corporate funding whatsoever. Further, modern science more generally is an enormously complex process for finding mistakes and exaggerations in each other’s research. And it helps that there’s significant overlap between the sciences, so no one group of scientists is ever truly isolated and free from scrutiny. Oversimplifying, you could say that biologists are double-checking the work done by the physicians, chemists are checking up on the biologists, and physicists are checking up on the chemists. (That’s why any physician who tries to use “quantum theory” in writing about disease had better be careful: there are armies of physicists waiting to explain just how irrelevant quantum mechanics is to human physiology.)

5) Competition. People often talk about Big Pharma as if it’s a monolith, one big organization, rather than a bunch of companies with divergent interests competing savagely with each other. That competition gives them every reason to attack each other’s weaknesses, and to point them out to the public. Add to that the fact that there are hundreds of smaller firms nipping at the heels of the big players. It’s far from a cozy conspiracy. This vicious competition of course means that there’s sometimes an incentive to cut corners in unscrupulous ways; but it also means that when you cut a corner, there’s always someone out there ready to point it out.

Now, again, this list is not supposed to lead to any particular conclusion about just how trustworthy Big Pharma is. It’s just a list of social and institutional mechanisms we need to take into consideration, in addition to the obvious bad track record and obvious financial incentives. Each of those mechanisms will apply to a greater or lesser degree with regard to specific situations. For particular issues, we need to think carefully both about what’s at stake, and about whether the above factors are likely to be sufficient to reassure us.

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Late-breaking Note:

I’ve been getting (and rejecting) comments full of unsubstantiated, and in some cases very dangerous, claims on some topics related to the above. When it comes to matters of health, if you’re not going to cite reliable sources, I cannot take responsibility for allowing your comments on here. There’s too much at stake, in terms of public health.

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