Archive for the ‘pharma’ Category

Can Big Pharma Learn to Self-Regulate?

A new study suggests that the pharmaceutical industry’s attempt to regulate its own activities with regard to advertising erectile dysfunction drugs has fallen far short of the mark. According to the study, co-authored by US professors Denis Arnold and Jim Oakley, some of the industry’s biggest companies failed repeatedly, over a period of years, to live up to the standards they set for themselves. The companies studied had all committed to the 2005 PhRMA Guiding Principles, but didn’t come close to living up to that commitment.

I suspect few will be surprised by this result, though they may be surprised by the extent of of the violations documented by Arnold and Oakley. Eli Lily’s Cialis campaign, Pfizer’s Viagra campaign, and Bayer Healthcare, GlaxoSmithKline, and Merck’s Levitra campaign violated more principles than they adhered to.

The notion of businesses regulating themselves raises plenty of eyebrows. Skepticism about business is high, and many people will find it hard to believe that profit-oriented businesses will respond to any rules that aren’t backed by the force of law. And the idea of the pharmaceutical industry — an industry not exactly famous for its ethics — self-regulating with regard to marketing a cash-cow category of drugs is sure to garner even more skepticism. Did anyone expect it to work in the first place?

But we shouldn’t let an example like this cast a pall over the notion of self-regulation more generally.

Self-regulation can mean lots of things. It can mean the tacit evolution of norms within an industry, a shared sense that “this is how things should be done.” It can mean efforts to establish industry-wide standards (such as GAAP) that end up being woven into legislated regulatory requirements, and enforced by courts. It can also refer to the simple fact that thousands of basic ethical issues are left up to individual businesses and individual employees. Some of those mechanisms can reasonably be expected to work reasonably well, for some issues. And others, unfortunately, probably cannot.

Self-regulation by means of industry-wide standard-setting is in some sense a best-case scenario for self-regulation. Companies within a single industry have a shared set of interests, including an interest in forestalling intrusive government regulation. They also in many cases form a true community, and are hence able to exert peer pressure on each other to promote compliance. Of course, as the Arnold and Oakley study demonstrates, it doesn’t always work.

And there’s a powerful argument in favour of making use of self-regulation where feasible. After all, government can’t be everywhere, and if it could be we couldn’t want it to be. Having government pass rules about every aspect of business operations and then monitor compliance with those rules would be both terribly expensive and brutally intrusive. The question isn’t whether self-regulation is a good idea. The question is for which issues will self-regulation work, and under what conditions? We need as a society to be able to rely on a good deal of self-regulation, and business needs to figure out how to do it.

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.

Lance Armstrong: How the Mighty (Book) Has Fallen

It's not about the bike.

Lance Armstrong: It’s Not About the Bike.

What are we to make, at this point, of Lance Armstrong’s best-selling 2000 book, It’s Not About the Bike: My Journey Back to Life? I have to admit that I never read the book, and my interest in doing so has not increased in the wake of accusations of doping. But why? After all, the book was a best-seller, one by an athlete whom many regard — still regard — as a hero.

The picture above is one I took, of a box of free books a neighbour of mine left outside on the sidewalk. When I ran by one recent Saturday afternoon, only one book remained: Armstrong’s book. Funny but sad, I thought. When I passed again roughly 24 hours later, the box looked exactly the same: just one book, unwanted even for free. I snapped a picture.

(Another perspective on the book’s value: Amazon is still selling the book, for about $11, though you can also buy a used copy via Amazon for just a penny — in other words, for the cost of shipping it.)

The book, as you can surmise from reading any of a number of reviews, tells the story of Armstrong’s rise to prominence in cycling, his battle with and ultimately triumph over cancer, through to his victory at the 1999 Tour de France. It is, in short, the story that made him a hero to so many.

We are now all but certain that Armstrong’s meteoric rise to the pinnacle of the cycling world was aided by pharmaceuticals, a sophisticated and rigorous doping program that he not only stuck to but bullied his teammates into adopting. Should he still be regarded as a hero in any sense? And is his book still worth reading? We all know now that the book left out crucial details, but as far as I’ve heard there’s no reason to doubt the basics: he had cancer, he had surgery, he “beat” the cancer, he trained hard, he won the Tour de France. So the basics of the hero story remain as valid today as they were when the book came out over ten years ago. So why is the book now effectively — literally! — consigned to the trash-heap?

For some, the explanation might be simple personal disillusionment. When a hero falls, he falls really hard. So some who previously lionized Armstrong may not want even to think back upon what they now see as their own naiveté. Others may not want to be ‘inspired’ by someone they see as a liar: perhaps they just don’t want to listen to life lessons and inspiring stories, no matter how useful, told by someone who cheated and then lied about it.

The best answer, I think, lies in the loss of trust. Armstrong’s message was one of hope and courage, and it can only really bring hope and courage to the reader if the reader trusts Armstrong’s words. Armstrong’s message was like that of the kind, experienced physician in whom the cancer patient puts his or her faith. “We’re going to take good care of you,” says the physician. Armstrong’s message: You too can triumph over adversity. Neither messenger can guarantee results: surviving cancer is much more a matter of luck, and good medical care, than it is of gutsy determination. But the other half of the message — the reassurance, the comfort, the message of hope — requires that the patient put their faith in the messenger. And that is the part of his own message that Armstrong so effectively killed.

Corporate Participation in the Death Penalty

grim reaperDrug companies are often accused of engaging in, or of complicity in, all manner of wrongdoing.

It’s less often (though certainly not unheard of) that they’re accused of participation in actual killings, or offered the opportunity to save a life. This is one of those cases.

The story begins here, with a heinous crime not committed by any corporation: Jury Finds Steven Hayes Guilty In Connecticut Triple Murder

Steven Hayes was found guilty today in the deadly home invasion that left a woman and her two daughters brutalized and murdered, making him eligible for the death penalty….

Hayes may well be executed, but only if a subsequent legal proceeding results in that decision, and only if the state of Connecticut has the help of a particular corporation, namely the one that supplies the drug necessary for lethal injection. And that help can’t be assumed. To begin, there are reports that one of the suppliers is having trouble supplying a key drug used in lethal injection.

Not everyone thinks that shortage is a bad thing. See this piece, by Jim Edwards, writing for Bnet: Why Hospira Should Stop Supplying Prisons With Lethal Injection Drugs

Hospira (HSP), the company that makes the lethal injection Pentothal used in death row executions, says the restricted supply of the drug that has halted executions across the country is caused by supplier issues and has nothing to do with the company’s distaste for the death penalty. But why shouldn’t Hospira cut off prisons from their supply of Pentothal?

Now, I don’t know whether Hospira is the company that Connecticut relies on to facilitate its executions (Ewards’ article lists only Oklahoma, Kentucky, Virginia, Arizona and California). But the drugs they use come from somewhere, either Hospira or another drug company.

So, I’m going to ask you to engage in an exercise in imagination. Forget, for a moment, what your own view on the death penalty really is. Ask yourself these two questions:

  • IF the death penalty is morally justified, is Hospira (or another company) required to sell the requisite drug to the state in question? May they opt out? Must they remain in some sense “neutral” on this hot-button issue?
  • IF the death penalty is morally unjustified, is Hospira (or another company) required not to participate? Or is the company blameless for its participation? If the company is blameworthy for participating, are we likewise to blame the company that makes the gurney that Hayes will lie in as the drug is injected? The company that makes the needle? Why or why not?

Again, even if you have strong views on the death penalty itself, please do your best to set that aside and consider more specifically the ethics of business participation in the practice.

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.

Business Ethics & Alternative Medicine

This is a “meta” blog posting, bringing together the various blog entries of mine over the last couple of years on the single topic of business ethics and alternative medicine.

Alternative medicine (includes things like homeopathy, herbal supplements, Traditional Chinese Medicine, acupuncture, therapeutic touch, and so on) raises some interesting ethical issues. On one hand, most of it doesn’t work (or to be more accurate, most of it is unproven, and much of it is disproven), and we tend to think people should only sell products that work as advertised. But on the other hand, alternative medicine has many fans, and we generally think consumers ought to be able to choose for themselves what products are good for them.

Two other factors make alternative medicine interesting, from a business-ethics point of view.

One factor is that both the safety and efficacy of alternative therapies varies. Some therapies (e.g., homeopathy) are entirely implausible, whereas others such as some herbal therapies probably are effective. Not surprisingly, the pattern is reversed for safety: homeopathy is entirely safe (unless the consumer does something foolish like forgoing real medicine in favour of homeopathic remedies for the treatment of a serious illness), while on the other hand some herbal remedies pose significant dangers.

The second important factor is that alternative medicine is generally under-regulated. In Canada, for example, herbal supplements are categorized as “natural health products” and subject to only minimal oversight. The result is that neither consumers nor companies can assume that the law is providing significant oversight. In the absence of strong consumer-protection legislation, there’s a particularly strong obligation for companies to act ethically.

Here are my blog postings on this topic, in reverse-chronological order:

By the way, to the best of my knowledge, there is not a single scholarly paper that looks at the selling of alternative medicines from a business-ethics point of view. If you know of one, please let me know!

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.)

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.

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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