STUPID HATRED OF DRUG COMPANIES

The fact that volume matters more than price means the emphasis of the prescription-drug debate is all wrong. We've been focused on the drug manufacturers. But decisions about prevalence, therapeutic mix, and intensity aren't made by the producers of drugs. They're made by the consumers of drugs. This is why increasing numbers of employers have in recent years made use of what are known as Pharmacy Benefit Managers, or PBMs. The PBMs draw up drug formularies--lists of preferred medications. They analyze clinical trials data to find out which drugs are the most cost-effective. In a category in which there are many equivalent options, they bargain with drug firms, offering to deliver all their business to one company in exchange for a discount. They build incentives into prescription drug plans to encourage intelligent patient behavior.

There is no mention of these successes in The Truth About the Drug Companies, [a new book by Dr. Marcia Angell, a physician and former editor of The New England Journal of Medicine]. Though much of the book is concerned with the problem of such costs, PBMs, the principal tool that private health care plans use to control rising drug costs, are dismissed in a few paragraphs.

Angell's focus, instead, is on the behavior of the pharmaceutical industry. An entire chapter, for instance, centers on the fact that the majority of drugs produced by the pharmaceutical industry are either minor variations or duplicates of drugs already on the market. Merck pioneered the statin category with Mevacor. Now we have Pfizer's Lipitor, Bristol-Myers Squibb's Pravachol, Novartis's Lescol, AstraZeneca's Crestor, and Merck's second entrant, Zocor--all of which do pretty much the same thing.

Angell thinks these "me-too" drugs are a waste of time and money, and that the industry should devote its resources to the development of truly innovative drugs instead. In one sense, she's right: We need a cure for Alzheimer's much more than we need a fourth or fifth statin. Yet me-too drugs are what drive prices down. The presence of more than one drug in a given category gives PBMs their leverage when it comes time to bargain with pharmaceutical companies.

Angell appears to understand none of this. "Medicare will have to pay whatever drug companies charge," she writes, bafflingly, "and it will have to cover expensive me-too drugs as well as more cost-effective ones."

The core problem in bringing drug spending under control, in other words, is persuading the users and buyers and prescribers of drugs to behave rationally, and the reason we're in the mess we're in is that, so far, we simply haven't done a very good job of that. "The sensitivity on the part of employers is turned up pretty high on this," Robert Nease, who heads applied decision analysis for one of the nation's largest PBMs, the St. Louis-based Express Scripts, says. "This is not an issue about how to cut costs without affecting quality. We know how to do that. We know that generics work as well as brands. We know that there are proven step therapies. The problem is that we haven't communicated to members that we aren't cheating them."

Among the costliest drug categories, for instance, is the new class of anti-inflammatory drugs known as cox-2 inhibitors. The leading brand, Celebrex, has been heavily advertised, and many patients suffering from arthritis or similar conditions ask for Celebrex when they see their physician, believing that a cox-2 inhibitor is a superior alternative to the previous generation of nonsteroidal anti-inflammatories (known as NSAIDs), such as ibuprofen. (The second leading cox-2 inhibitor, Merck's Vioxx, has just been taken off the market because of links to an elevated risk of heart attacks and strokes.) The clinical evidence, however, suggests that the cox-2s aren't any better at relieving pain than the NSAIDs. It's just that in a very select group of patients they have a lower risk of side effects like ulcers or bleeding. "There are patients at high risk--people who have or have had an ulcer in the past, who are on blood-thinning medication, or who are of an advanced age," Nease says. "That specific group you would likely start immediately on a cox-2." Anyone else, he says, should really be started on a generic NSAID first.

"The savings here are enormous," he went on. "The cox-2s are between a hundred and two hundred dollars a month, and the generic NSAIDs are pennies a day--and these are drugs that people take day in, day out, for years and years." But that kind of change can't be implemented unilaterally: The health plan and the employer have to explain to employees that in their case a brand-new, hundred-dollar drug may not be any better than an old, one-dollar drug.

There is a second book out this fall on the prescription drug crisis, titled Overdosed America (HarperCollins; $24.95), by John Abramson, who teaches at Harvard Medical School. At one point, Abramson discusses a study he found in a medical journal, concluding that the statin Pravachol lowered the risk of stroke in patients with coronary heart disease by 19 percent. That sounds like a significant finding, but, as Abramson shows, it isn't. In the six years of the study, 4.5 percent of those taking a placebo had a stroke versus 3.7 percent of those on Pravachol. In the real world, that means that for every thousand people you put on Pravachol you prevent one stroke which, given how much the drug costs, comes to at least $1.2 million per stroke prevented.

Here is a classic case of the kind of thing that bedevils the American health system: dubious findings that, without careful evaluation, have the potential to drive up costs. But whose fault is it? It's hard to blame Pravachol's manufacturer, Bristol-Myers Squibb. The study's principal objective was to look at Pravachol's effectiveness in fighting heart attacks; the company was simply using that patient population to make a secondary observation about strokes. In any case, Bristol-Myers didn't write up the results. A group of cardiologists from New Zealand and Australia did, and they hardly tried to hide Pravachol's shortcomings in women and older people. All those data are presented in a large chart on the study's third page.

In the end, the fight to keep drug spending under control is principally a matter of information, of proper communication among everyone who prescribes and pays for and ultimately uses drugs about what works and what doesn't, and what makes economic sense and what doesn't, and medical journals play a critical role in this process. As Abramson writes: "When I finished analyzing the article and understood that the title didn't tell the whole story, that the findings were not statistically significant, and that Pravachol appeared to cause more strokes in the population at greater risk, it felt like a violation of the trust that doctors (including me) place in the research published in respected medical journals."

The journal in which the Pravachol article appeared, incidentally, was The New England Journal of Medicine. And its editor at the time the paper was accepted for publication? Dr. Marcia Angell. Physician, heal thyself.

More here

***************************

For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

***************************