The Chicago Tribune has a good article on a developing issue in the prescription drug field: the patent on one of the leading “statins” - cholesterol-reducing drugs - is about to expire, opening the way for generic drug equivalents at lower prices. Glenn McGee’s take on this development: “Large fries. Greasy pizza. And in Philadelphia, scrapple and cheesesteaks. A bright future beckons.” - but there is a lot more at steak than cheap penance for bad habits. This development is already - 6 months ahead of time - setting off ripples in the drug-pricing field that illustrate certain common themes in the area of access to healthcare and healthcare financing.

Zocor, the No. 2 selling drug in the United States, goes off patent in June, setting the stage for a cheaper generic copy of what has been a pricey prescription for millions of Americans, their employers and insurers for several years. . . .

Zocor’s co-payments as a generic could be half of the co-payments of branded products like Lipitor and AstraZeneca PLC’s Crestor. Because Lipitor, Zocor and Crestor are in the same class of drugs, called statins, health insurance plans and pharmacists are going to be encouraging consumers to pick a generic of Zocor because the statins are deemed similar, analysts say. . . .

Perhaps even more problematic for brand-name rivals of Zocor is that some pharmacy benefit managers will begin listing brand-name Zocor as a “preferred brand” name in their preferred lists of drugs, known as formularies, even before the drug goes generic. . . .

By putting Zocor into a preferred category before it goes to generic, “pharmacy benefit managers are trying to make branded Zocor their [plan enrollees’] first choice, that way the switch to generic is going to be easier,” said Al Rauch, pharmaceutical industry analyst for A.G. Edwards in St. Louis. “The whole idea is to get people prepared for a generic . . . a therapeutic substitution.”

In other words, not only are benefit managers engaging in the traditional maneuvers of raising premiums and charging extra for “off-list” drugs, to force patients to use only those medications that are cheapest to provide, rather than the ones the patients want, they are going further to deliberately manipulate patients into using particular drugs that are about to go generic, so those patients will then come to accept those drugs as their “regular” medication and thus prefer the generic version of the same drug when it becomes available.

The justification for this is the claim that not only are generic and name-brand versions of a given drug equivalent, but in some cases all drugs of the same pharmacological category are deemed equivalent (by the non-clinicians who serve as “benefit managers” for the payer organizations).

“This [statin] class of medications is similar in action and they have been proven to do pretty much the same thing,” said Elizabeth Young, a pharmacist who is director of formulary services for Walgreens Health Services, the managed-care subsidiary of pharmacy giant Walgreen Co., the nation’s largest drugstore chain.

“Lipitor, Zocor and Crestor are pretty much interchangeable,” Young added. “It’s a great win for consumers.”

However, name-brand manufacturers can cite studies showing slight differences between medications, and then claim that theirs is preferable, at least for some subset of patients.

Less than half of all patients being treated for high cholesterol are getting to goal–and it’s even worse for those patients who are considered high-risk,” said Emily Denney, spokeswoman for AstraZeneca, maker of Crestor. “We know that Crestor can help many of these high-risk patients lower their cholesterol better than other leading statins.”

Pfizer pointed out head-to-head studies showing its Lipitor has advantages over Zocor, including lowering risks of heart disease.

“You really have to think about what is best for patient care,” said Dr. John Tsai, a cardiologist and Pfizer’s medical team leader for Lipitor. “The best care based on these clinical trials is that Lipitor shows benefits you get in terms of cardiovascular risk.”

[Note the distinctions: one study shows more patients on Crestor reach their goal cholesterol level; another study shows more patients on Lipitor avoid clinical heart disease. And so it goes.]

And, of course, marketers of the name-brand drugs are using exactly the same tactics to protect their market share as payer organizations are using to shift patients to lower-cost medications:

To combat the push by pharmacies and insurers of patients toward generic Zocor, the drug’s rivals are expected to step up advertising and marketing. Pfizer already spends more than $100 million on promoting Lipitor to doctors and consumers, and analysts expect the company will step that up in 2006.

“They want to encourage people to be on Lipitor now because once Zocor goes generic, there will be a heavy push [by pharmacy benefit managers] to put them on the generic,” Rauch said.

As with the tactic used to shift patients to generics (penalize them for using any any name-brand drug other than one that is just about to go generic, then feed them the generic alternative when it becomes available), the “bait-and-don’t-switch” is used by the patent-drug makers as well: convince consumers or doctors that there is some benefit to using a name-brand drug, and build up their reluctance to switch when a generic version of a competing drug becomes available.

The clinical issues are complicated but not unresolvable: many competitors in large drug classes do have similar effects and are somewhat interchangeable, but not in all cases. There is also extensive research suggesting that quality control among many generic drug makers is not as high as among the name-brand originators of the drugs, and that the substitution of different supposedly non-active ingredients can be problematic. But in principle it should be possible to determine which drugs are safely interchangeable with which others. And in principle this information should be valuable in determining which drugs are worth a premium in comparison to which others.

The problem, of course, is that, although much of this information is available, it plays almost no role in determining which drugs are made available to patients. The decisions that are made are made on almost entirely financial grounds: payers invariably argue that all drugs of a given kind are equivalent and use whatever coercion they can command - namely, imposing added costs for people who have already paid the premium for health covereage in the first place, if they do not accept the treatments and conditions imposed by the payer - to force patients into accepting the cheapest one available without reference to that particular patient’s clinical condition or history; drug makers invariably argue that their one drug just happens to be the best available for a particular condition, and that no substitute, and even no equivalent, would be acceptable, thus payers must accept the price demanded by the maker as the only reasonable means of providing patient care.

If these patterns were not so predictable, and the financial motivations behind them not so nakedly obvious, it would be worth considering whether some coercion of patient preferences might not result in a more efficient healthcare system. But the towering conflicts of interest driving the major players in this cynical game, and the fact that, without exception, the supposed professionals employed by each side just happen to come to the conclusion that the interests of patient care and ethics coincide precisely with their employers’ financial interests in every case, make any of this too much to swallow. Like the most manipulative of politicians or the most dishonest of debaters, each side seizes on trivial claims favoring its position and declares them decisive, gutting not only fact-based clinical decisionmaking but the idea of science-based medicine itself.

The result is that consumer choice is constrained entirely by the financial interests of those who have the power to influence the consumers’ behavior (which is to say: to penalize them for acting on unapproved healthcare preferences) - even when developments favor the consumers’ interests! Generic drugs are a good thing for patients - when they are clinically appropriate, and when they add to patients’ ranges of choices and treatment alternatives. When they are imposed as the cheapest and only alternative whether patients prefer them or not - or at least when all other alternatives are held behind a barrier of a 50% or more price penalty - they are simply another way to sell patient welfare down the river for others’ financial gain.

Glenn McGee may be ecstatic over cheap treatment for the heart disease he’s eating himself into, but I’ll bet he has a health plan that makes it possible for him to get what he really needs if he really needs it. Few Americans do; what they get is what someone else decides they need, on the basis of that other party’s interests - which is enough to give you heartburn without the cheesesteak and pepperoni pizza.

Hat tip: AJOB/bioethics.net

This begins the first full calendar year of Sufficient Scruples. The last 6 months or so have been interesting and fun, but I’m still struggling to build readership, and trying to figure out how to make the blog as unique and as useful as possible. Sufficient Scruples is not quite a “new blog” anymore, but I think of the last half of 2005 (since the birth of the blog) as a shakedown period. Beginning with the New Year, I want Sufficient Scruples to play a distinct and particular role in ethics blogging, and to perform a service for readers with a certain perspective on these issues.

As many past posts should make clear, my penchant is for longer, discursive entries, and not so much commentary on every “breaking news” item that pops up. My temperament and the amount of time I have to put in make this work better for me. And there are lots of bloggers keeping abreast of the headlines - most of them are better than me.

So one thing I will try to do is find more issues of real significance in conceptual or ethical terms - rather than those that happen to be relevant as of the moment - and focus on teasing out what they have to tell us about ethical health care in general. Sufficient Scruples will be a place where particular incidents and news events will serve to illustrate larger ethical themes, and perhaps point up conflicts or difficulties attending the principles that relate to those issues.

I will also try to post more regularly, though it’s hard doing it alone, especially if you make a habit of longer posts. But this at least frees me from feeling guilty that I’m not discussing every latest event or hot topic. Look to the right and you’ll find a blogroll full of up-to-the-minute bloggers who are really hot on current issues, and have great things to say.

Another thing I will do is get podcasts going as soon as possible. (I’m jonesing for the Blue Snowball, the best USB microphone available, and at $139 just exactly $139 more than I can afford.) That was part of the original plan, but it fell by the wayside during a somewhat trying second half of 2005.

Also, I will try to expand the library of “White Papers”. (I hope to god someone’s reading those.) Any feedback on whether those essays are useful, or suggestions as to issues on which you would like to see a broad, expository discussion, are welcome.

In these ways and others I hope to supercharge Sufficient Scruples in 2006 and move onward and upward. I hope there is a niche for considered, long-form (by blogging standards), deliberative discussion of ethical principle in the healthcare setting. That’s what I will try to provide; we’ll see how well it works.

One problem, though, is readership. I don’t seem to have any. It’s still early days, but things are definitely lagging in that department, which is very frustrating. Posting and linking more will help, but I don’t know what else to do. One plea I would make to readers: say something! I know I get more readers than comments - go ahead and give some feedback, respond to each other, let me know y’all are out there. I can talk to myself at home. Seriously, it would help me feel this was worth doing if I knew that anyone was listening.

But for those who are, thanks so much, and stick around. 2006 is a new beginning and a new opportunity! Help me make the most of it!