Archive for the ‘product safety’ Category

Herbal Remedy Scam

It’s a quality control problem at best, and outright fraud at worst.

A recent study by researchers at the University of Guelph used genetic analysis to study a range of commercial herbal remedies and found a shocking disparity between what was on the label and what’s actually in the bottle.

According to the Vancouver Sun, the researchers looked at 44 herbal products sold by 12 companies, using DNA ‘barcode testing’ to determine what plant species were in the bottle.

The result: some products contained other generally inert species of plants (for example wheat, to which some people are allergic, and rice, to which some people are allergic), without those ingredients being listed on the label. Other products were adulterated with potentially toxic plants like St. John’s wort or senna. Others simply contained none of the active ingredient they were supposed to contain. And yet these products are commercially available at a major pharmacy chain near you.

The study didn’t name names — the study was effectively about quality control within the industry, rather than about naming-and-shaming particular companies. But it’s a damning indictment for the industry quite generally. (Just two companies among the 12 in the study sold products that were just what they said they were.)

Of course, many readers will know that this is not the first reason we’ve had to doubt the integrity of the herbal remedy industry, or the ‘natural’ health product industry more generally. As others have written elsewhere (including pharmacists with the scientific and critical-thinking chops to know the difference), Canada’s regulations regarding natural health products leave much to be desired.

But it’s nothing to laugh about. Unlike homeopathic remedies, which (unless adulterated) generally contain no active ingredients at all, herbal remedies can have actual effects, though those effects may not live up to the claims implied by their labels. Herbal remedies, while under-regulated, can at least have real biological effects. That’s a source of pride for makers of herbals, situated as they are within an alternative-medicine industry that is rife with outright fraud and delusion.

But it also means that the honest bottlers of herbal remedies should be at the front of the line, lobbying government hard for stricter regulations. Perhaps even more crucially they should be doing their best to convince the major chains that there’s a difference between them and the companies whose products failed the Guelph study so miserably. In the end, it’s as much an ethical matter as a matter of self-interest. The public deserves to be better served, and who better than those within the industry itself to make sure that it happens?

Pharma and the Spirit of Competition

Once again, the pharmaceutical industry is under attack, and once again it is for all the wrong reasons.

The problem this time is this: many of the new generation of blockbuster drugs are jaw-droppingly expensive, costing tens of thousands of dollars per patient per year or even per treatment. Part of the reason is that many of them are from a category of drugs known as “biologics.” Such drugs aren’t made with old-fashioned chemistry, but are instead produced inside living cells, typically genetically modified ones, inside giant vats known as bio-reactors. It’s an expensive new technology. And the big biotech firms that make these drugs are not fond of competition.

According to the New York Times, “Two companies, Amgen and Genentech, are proposing bills that would restrict the ability of pharmacists to substitute generic versions of biological drugs for brand name products.”

The companies claim they’re just trying to protect consumers. The generic versions, they argue, are typically similar, but not identical, to the originals. These aren’t simple drugs like Aspirin or the blood thinner, Coumadin. These are highly complex molecules, and the worry is that even slight differences in the manufacturing process could lead to problematic differences in form and function.

The makers of generics, for their part, acknowledge that worry, and say they’re fine with pharmacists limiting substitution to cases in which the Food and Drug Administration has declared two drugs to be interchangeable. But they oppose any further restrictions, including ones that might be imposed at the state level and for which the name-brand manufacturers are lobbying mightily.

What are we to say, ethically, about efforts by name-brand manufacturers to limit competition and thereby keep prices and profits high? Is it wrong of them to do this in a context in which health spending is out of control, and in which patients can die from being unable to afford a life-saving drug?

But as strange as this may seem, there is arguably nothing wrong with pharma behaviour that harms patients and strains private and public healthcare budgets. They aren’t responsible for the fact that people get sick, and they’re not (usually!) responsible for the decisions made by governments or by insurance companies. A lot of the behaviour on the part of pharma that people complain about is no more wrongful than the behaviour of the woman who invents a better mousetrap, thereby putting employees of the less-good mousetrap maker out of business. Innovative, competitive behaviour is good in the long run, but net social benefit is consistent with less-good outcomes for some.

The real sin, here, isn’t against consumers or governments, but against the market itself.

Markets, and the businesses that populate them, can only promise to be socially beneficial when there is competition. When governments move to foster competition, businesses that profess to believe in free markets cannot rightly cajole governments to do otherwise. The same goes for using lobbyists to encourage government to make a market less competitive. After all, playing by the rules of the game is the fundamental obligation of business. But when it comes to changing the rules of the game, we have to look to the limits implied by the spirit of the game. That’s where pharma is going astray here. Using government to limit competition isn’t just bad ethics; it’s bad capitalism.

GMO Labelling and Consumer Rights

Next month, Californians will vote on Proposition 37, regarding the mandatory labelling of genetically modified foods. Because it’s about food, and because it’s taking place in California — a place where they take their food and their plebiscites seriously — the effort has been highly-publicized and highly politicized. California is both an important agricultural state and the state with perhaps the highest concentration of believers in the “Natural is Good” mantra. So it’s not surprising that the fight over Prop 37 is raising some dust.

One of the favourite slogans of the pro-Prop37 forces is the claim that consumers have a right to know what they’re eating. This is a strong claim. Using the language of rights is a way of making the strongest possible kind of ethical claim, a way to draw a line in the topsoil, as it were. To say that someone has a right to something is quite different from saying merely that “it would be good if we did this” or “good people and good companies do this sort of thing.” It expresses a kind of moral absolute.

Indeed, if it were true that consumers really have a strong right to know what they’re eating — including, presumably, a right to know the genetic makeup of their food — then Prop 37 ought to be redundant. Any corporate citizen worth its salt makes every effort to respect its customers’ rights. When there is a right to some piece of information, institutions and methods of production need to be designed and implemented to respect and promote such rights.

But the idea that we have a right to know what we’re eating can’t stand up to scrutiny, at least not if we define “what we’re eating” to include every aspect of the food’s makeup and indeed its history. Counter examples are easy. If you’re sipping a Coke, do you have a right to know the exact proportion of various ingredients? No, that’s a secret. If you’re eating in a restaurant, do you have the right to know the Chef’s method for searing your tuna steak so perfectly? Of course not — though you of course have the right to eat elsewhere.

Or consider this example: do you have the right to know whether the banana you’re eating was picked on a Thursday? (Imagine that Thursday is a holy day in your religion.) No, because recording and tracking day-of-harvest for boatloads of bananas would be difficult and expensive. Yes, the fact might matter to you a lot, but there are other ways of accommodating your interest in that information, short of attributing a morally weighty (let alone legally binding) right to it. Taken seriously, the right to know your food’s history even implies that the racist or sexist or homophobe has a right to personal information about the people who handled their food along the supply chain. And yet surely there is no such right to information that let’s someone act out their prejudices.

The point is that people might want to know all sorts of information about the food their eating. And that’s fine. But saying they have a right to it is a different thing altogether. Rights protect important interests. And there simply is no compelling evidence that anyone needs to know that genetic makeup of their food, or that a right to such information would protect any important consumer interest.

Addendum:
For more, see my previous entry on the “Right to Know What I’m Eating” over at my Food Ethics Blog.

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.

Philip Morris: Endangering Kids and Academic Ethics

Tobacco giant Philip Morris is doing its best to get its hands on research about teen smoking, and encouraging some UK academics to violate ethical standards along the way.

Here’s the story, by Andrew Hough for the Telegraph: Philip Morris: tobacco firm using FOI laws to access secret academic data

Philip Morris International has tried to force the University of Stirling to hand over secret data into teenage smoking and cigarette packaging gathered over more than a decade.

The manufacturers behind the popular Marlboro brand, have used Freedom of Information laws to [attempt to] gain access [to] about 6000 confidential interviews undertaken with teenagers as young as 13, which discuss their views on smoking and tobacco….

The researchers are rightly fighting the request.

It’s a shocking move on Philip Morris’s part, even just from a PR point of view. To be seen seeking information that the company clearly hopes to use in marketing to children will do nothing to improve anyone’s opinion of the firm or the industry.

But there’s a second wrong, here, and that lies in the attempt to get the researchers in question to violate their obligations to the research subjects — the children and their parents — who participated in the research in question.

When university-based researchers conduct any kind of research on human beings, they are required to adhere to pretty strict standards for research ethics. The most fundamental of those standards has to do with obtaining informed consent from research subjects. Such consent may be obtained only after research subjects are fully informed about the goals of the research, as well as about what sorts of privacy protections they can expect. In the case described here, it is almost certainly the case that the children interviewed, and their parents, would have been assured that while the researchers would of course eventually make public the aggregate results of their research, the raw data — the interview transcripts that Philip Morris seems to be seeking — would of course be kept confidential.

So Philip Morris is asking these researchers to break their promise and to breach the trust placed in them by research subjects. The company is attempting to get the researchers to violate their duty. This puts the company’s behaviour into the same moral category as suborning perjury or intentionally putting another party into a conflict of interest. It’s a bad thing when a company violates its own duties; but it is especially corrosive to work so hard at encouraging other people to violate theirs.

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.

Glock Pistols, Ethics and CSR

It’s been a week now since the Tuscon, Arizona killings in which Jared Lee Loughner apparently emptied the high-capacity magazine of his 9 mm pistol.

Plenty has already been written about the awful killing. Inevitably, some of it has focused on the weapon he carried, namely the Glock. According to Wikipedia’s Glock page,

The Glock is a series of semi-automatic pistols designed and produced by Glock Ges.m.b.H., located in Deutsch-Wagram, Austria.

Despite initial resistance from the market to accept a “plastic gun” due to concerns about their durability and reliability, Glock pistols have become the company’s most profitable line of products, commanding 65% of the market share of handguns for United States law enforcement agencies[5] as well as supplying numerous national armed forces and security agencies worldwide….

If you want to learn more about the company that made the pistol Loughner used, see this article, by Paul M. Barrett for Bloomberg Businessweek, Glock: America’s Gun

…Headquartered in Deutsch-Wagram, Austria, the company says it now commands 65 percent of the American law enforcement market, including the FBI and Drug Enforcement Administration. It also controls a healthy share of the overall $1 billion U.S. handgun market, according to analysis of production and excise tax data. (Precise figures aren’t available because Glock and several large rivals, including Beretta and Sig Sauer, are privately held.) ….

Barrett’s article provides a fascinating account of the invention of the Glock pistol and how it came to its current dominant market position through a combination of excellent engineering, good marketing and cagey lobbying.

The sale of semi-automatic pistols with high-capacity magazines is a good example of an issue where the term “corporate social responsibility” provides a useful analytic lens. I’ve argued here before that the term “CSR” is over-used — we shouldn’t try to stuff every single ethical issue into the relatively narrow notion of corporate social responsibility. But like the BP oil spill, the current case raises issues that are genuinely social in nature. As difficult as it may be, set aside for a moment the tragic events of January 8th, and look at the marketing of the Glock pistol (and its accessories) from a social point of view.

Do Americans as individuals have the right to buy certain kinds of weapons? As a matter of constitutional law, yes. And there’s arguably no direct line to be drawn between the sale of an individual gun and a particular wrongful death (because there’s always the complicating factor of the decision made by the individual who bought the gun and then pulled the trigger). So let us take as given (even if just for the sake of argument) that there’s nothing intrinsically wrong with making and selling guns to the public. Let us assume that individual customers have a legitimate interest in owning semi-automatic pistols, and there’s nothing unethical about a company seeking to make money from satisfying the demand for this entirely-legal product.

That still leaves as an open question, I think, the question of social impact. The best rationale for public acceptance of the kind of zealous, profit-seeking behaviour seen in the world of business lies in the social benefits that arise from a vigorous competitive marketplace. This implies that the moral limits on business are also to be found in a business’s net social impact.

There is a raging debate, in the US, over the net social impact of the sale of handguns. And where a product is contentious, you can argue that “the tie goes to the runner,” and that the “runner” in this case is freedom. When in doubt, opt for freedom of sale and choice. So let’s say (again, if only for sake of argument) that there’s nothing wrong with selling handguns to the public. So Glock (the company) is justified in existing and in carrying out its business. That still leaves open the question of the particular ways in which handguns and their accessories are marketed. The social benefits of selling handguns may be fundamentally contentious; in other words, reasonable people can agree to disagree. But I doubt that the same can really be said for marketing moves designed, for example, to foster the sale of high-capacity magazines (ones that hold 33 bullets instead of the usual 17).

I’m not presuming to answer that question here; I’m merely pointing out the significance, and appropriateness, of a specifically social lens.

——
(See also Andrew Potter’s characteristically sane piece on the politics of gun control: ‘You can’t outsmart crazy’—or can you?)

Lead Content in Products for Children Adults

Selling products for kids is a tricky business. We adults are, to a certain extent, willing to adopt a “buyer beware” attitude. But kids deserve protection — the duty to protect children is a universal ethical norm. Add to that the fact that they are simply more physically vulnerable, and it’s not hard to see why we expect (and impose) higher standards of behaviour on the part of companies that make products aimed at kids.

That implies all kinds of ways in which manufacturers need to exercise caution: in product design, in the sourcing of parts and ingredients, in the manufacturing process, and in marketing. One way to avoid the extra hassle: make a product for kids, ignore the relevant safety standards, but make sure that you claim, when asked, that it’s really not for kids at all.

Here’s the story, by Justin Pritchard for The Associated Press: Feds dismiss recall on lead glasses

A federal agency reversed itself Friday and said lead-laced Wizard of Oz and superhero drinking glasses are, in fact, for adults — not children’s products subject to a previously announced recall.

The stunning about-face came after the Consumer Product Safety Commission said last month the glasses were children’s products and thus subject to strict federal lead limits.

Lab testing by the Associated Press found lead in the colored decorations up to 1,000 times the federal maximum for children’s products. The CPSC has no limits on lead content on the outside of adult drinking glasses….

The story here is in part about the odd decision by the Consumer Product Safety Commission. But I want to focus on the decision the company here made.

Now, I might have been a bit harsh when I implied above that the company making these glasses is being disingenuous when they say the glasses really aren’t for kids. Who knows what their intentions were? Our default assumption about people’s intentions should be a fair and charitable one, in the absence of evidence to the contrary. But that of course highlights the difficulty with a regulation based on divining a company’s intentions:

Under federal law, an item is a “children’s product” if it is “primarily intended” for those 12 and under.

Now on one hand, regulation based on intent makes a good deal of sense. If the relevant standards for kids’ products really is different, there really is no other way to draw a line between what counts as a product for kids and a product for adults. There’s nothing stopping parents from giving their kids access to products that are clearly “for” adults. So it seems fair for companies to be able to say, look, we intended that product for adults…it’s not our fault if some parents decided, instead, to give our product to their kids.

But I also think it’s worth pointing out that while regulations may focus on the manufacturer’s intentions, the relevant ethical standard should point to reasonable expectations. The makers of the glasses in question here may well have intended their product to be used primarily by adults, but the question they should have asked themselves is whether glasses with fantasy characters on them can in fact reasonably be expected to end up in the hands of kids. And if so, they should adhere to standards that are relevant to that expectation.


Thanks to LH for alerting me to this story.

Deadly Crashes, “Agency Theory” & the Challenges of Management

Sometimes for a corporation to “do the right thing” requires excellent execution of millions of tasks by thousands of employees. It thus requires not just good intentions, but good management skills, too.

For an example, consider the story of the crash of a Concorde supersonic jet a decade ago. The conditions leading up to the crash were complex, but one factor (according to the court) was negligence on the part of an aircraft mechanic. Whether (or to what extent) that mechanic’s employer is responsible for that negligence, and hence at least partly responsible for the crash, is a difficult matter.

Here’s the story Saskya Vandoorne, for CNN: Continental Airlines and mechanic guilty in deadly Concorde crash

The fiery crash that brought down a Concorde supersonic jet in 2000, killing 113 people, was caused partially by the criminal negligence of Continental Airlines and a mechanic who works for the company, a French court ruled Monday.

Continental Airlines was fined 202,000 euros ($268,400) and ordered to pay 1 million euros to Air France, which operated the doomed flight.

Mechanic John Taylor received a fine of 2,000 euros ($2,656) and a 15-month suspended prison sentence for involuntary manslaughter….

I don’t know the details of this story well enough to have any sense of whether the mechanic in this case really did act negligently. But what intrigues me, here, is the issue of corporate culpability. Note the difficulty faced by airline executives who (for the sake of argument) want desperately to achieve 100% efficiency and never, ever to risk anyone’s life. In order to achieve those goals, executives have to organize and motivate hundreds or perhaps thousands of employees. They need to design and administer a chain of command and a set of working conditions (including a system of pay) that is as likely as possible to result in all those employees diligently doing their very best, all of the time. That challenge is the subject of an entire body of political & economic theory known as “agency theory.”

Agency theory and the various mechanisms available to motivate employees in the right direction are things that every well-trained business student knows about, because those are central challenges of managing any corporation, or even any small team. What is recognized too seldom, I think, is just how central a role agency problems play in assessing and responding to ethical challenges in particular.

California’s Marijuana Industry: Ethical Issues

I’ve blogged about the insurance industry, the mining industry, the auto industry, even the donut industry. But the pot industry? Yes, it’s time.

From the Sacramento Bee: Growth of California’s Pot Industry is Good News for Unions

As Californians prepare to vote on a November ballot initiative that would expand legalization to recreational pot use, labor groups see the potential for perhaps tens of thousands of unionized jobs.

United Food and Commercial Workers Union, Local 5, which has 32,000 members in California working in trades including the grocery and food processing industries, began organizing marijuana “bud tenders,” greenhouse workers, packagers and laboratory technicians last spring….

So, here a budding industry, built around a controversial product that is illegal in most jurisdictions. There’s plenty of grass-root support for broader legalization (both for medicinal and recreational use). But there may be enough opposition to blunt the enthusiasm of law-makers about sudden moves. The support of politically-powerful unions is another ethically-significant factor — as is the potential capture of this new industry by unions.

This is such a rich and interesting story that there’s too much in it for me to try to hash it out by myself without resorting to quick, potted answers. So here are a handful of questions to seed the discussion. I’ll let you weed the good from the bad.

  • Ryan Grim reports that “The teachers union, citing the revenue that could be raised for the state, is also backing the initiative.” Is that sufficient reason? You don’t have to be an anti-pot puritan to worry about anything that might (inadvertently) encourage use of pot by school-age kids.
  • What business ethics issues are faced by producers and sellers of pot in the illegitimate parts of the drug industry? What new issues will the newly-legitimized industry face?
  • What CSR-type responsibilities does the (expanding) legal marijuana industry have?
  • Why are California Beer & Beverage Distributors lobbying against the proposed change? (See useful discussion over at Marginal Revolution).
  • What sorts of regulations should the industry seek? What motives will be foremost in industry’s mind in his regard — protecting revenues? protecting its image? protecting consumers?
  • Will the other drug industry — the pharmaceutical industry — move into this line of business? Why or why not?
  • Is the unionization of this industry generally a good or bad thing? Unionization improves the lot of workers, but also tends to raise prices. Since unionization itself is controversial, let’s ask it this way: is the case for unionization stronger or weaker, with regards to the marijuana industry?

I’ll open the floor for discussion.

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