Re: VIOXX, PRODUCTS LIABILITY AND HEALTH CARE
Below is a WSJ article on Merck's withdrawal of Viox, the arthritis drug, from the markets. But first a little color.
This summer at Tahoe I met Bruce C., 62 years old, and the most engaging retired teacher you could ever imagine. He loved teaching, refused to go into "administration", and has a thousand charming stories about his kids, every one of whom he gave pet nicknames.
Six mornings a week, Bruce bicycled the 7 miles up "Blackwood Canyon" and then 7 miles back; beautiful, but so difficult that I only did it 3 times! But Bruce has severe arthritus and he literally loved Vioxx. As it is, he can' even take long walks, but with Vioxx he could do wonders on a bike. He is one of those roughly 4.5 million people for whom no other drug will do, who faces severe stomach bleeding if he uses conventional medicines.
So Bruce is devastated; and this is no exaggeration: his whole lifestyle will change; he risks becoming a crumpled up old man. It is life changing.
The trial lawyers are already gearing up, setting up web sites to coordinate their assault against 'corporate greed and all those who care more about their profits' than looking out for the little guy.
Reading between the lines, Merck took this very beneficial drug off the marketplace even though their is a large class of users who benefit more than they risk. Merck simply couldn't afford to risk their corporate existence.
The story is not unique and if anything will become more common in the years ahead.
Bruce L
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Good Drug, Bad Customers
October 6, 2004; Page A19
Merck's Vioxx migraine illustrates why the nation is queasy about its health-care system, and the problem isn't primarily naughty, conniving drug companies. Vioxx was hardly a bad product. Among a handful of Cox-2 inhibitors designed in the lab to behave like aspirin and other nonsteroidal pain relievers, but without the propensity to induce stomach bleeding, Vioxx was the sole entrant whose tummy gentleness was demonstrated in a controlled study.
That made it a pill with unambiguous value to a clear subset of patients: 4.5 million arthritis sufferers who are at high risk of stomach bleeding, which can be a surprisingly fatal side effect of taking conventional pain relievers. However -- good news/bad news -- the Cox-2 drugs actually racked up $5.6 billion in sales last year, 65% of which was accounted for by patients not at risk for bleeding ulcers. So whose fault is that?
Insurance companies blame drug advertising and doctors who prescribe the newest and most expensive drug whether or not it's necessary. Doctors blame demanding patients who've been exposed to the industry's ads and, sotto voce, trial lawyers who might file a malpractice claim if a patent keels over from a bleeding ulcer.
Drug companies, for their part, aren't in the business of bad-mouthing those who prescribe their drugs and those who pay for them. Still, they note that, heck, doctors and insurers are in a better position to judge which drug is best for a given patient.
But here's the real answer. As a matter of statistical revelation, drugs turn out to be part of the health-care system, exhibiting all the maladies thereof. Bruce Stuart at the University of Maryland examined thousands of patient records and found that whether a patient took a Cox-2 or a cheaper drug was determined less by medical need than by whether or not an insurance company was picking up the tab.
That's not a comfortable place to be for a drug company that depended on Vioxx as much as Merck did for its profits -- especially when a late-breaking study revealed that all those not-strictly-necessary customers were taking an unwitting, small risk (about twice that of a placebo group) of heart attack or stroke. As CEO Raymond Gilmartin noted last week in withdrawing Vioxx from pharmacy shelves, Merck might have tried just slapping a new, expanded warning label on the drug. He decided to yank it altogether, though, "given the availability of alternative therapies."
Translation: "We have to get it out of the hands of people who would have been just as well off with aspirin or Tylenol or Advil." And while we're putting words in his mouth, let's finish the thought: "When the smoke clears, and when a subset of patients for whom Vioxx has been a genuine Godsend raise their voices, we'll bring it back with a new label."
More than anything else, the episode illustrates how bollixed up our health-care financing system is. That bollixing is particularly detrimental to drug companies, or so we'd argue, because their products are rigorously tested and, unlike much of health care, can offer unambiguous value in the hands of the right customer.
Merck's Vioxx ads, like all mass-market ads, bombarded everyone in hopes of capturing just a few for whom the message was directly appropriate. In a normal marketplace, potential customers would have quickly sorted themselves into two groups: those arthritis sufferers who've tried everything and can't get pain relief without tummy risk, thus are willing to pay top dollar for Vioxx; and those who take one look at the steep price and decide Tylenol, Motrin or store-brand aspirin are just fine.
Health care is not a normal marketplace. Drug companies, in fact, are about the last major providers for whom out-of-pocket spending by actual consumers is still a significant source of business. In 2000 (the latest data from the federal government), 46.1% of prescription drugs were bought directly by consumers, 33.9% were paid for by private insurers, and government paid for the rest.
This will shift dramatically when the elderly, our biggest pill poppers, begin having their pills paid for by Medicare. But drug companies already have been adapting themselves to a third-party payership world. They've become leading champions of "disease management," which in some of its more esoteric dimensions only makes sense in a managed care world.
Take the Cox-2s. Common pain relievers send an estimated 107,000 patients a year to the hospital with stomach bleeding, of whom 16,500 die, and 80% never felt a twinge of warning symptom. Dr. Gurkirpal Singh, the acknowledged authority on the subject, estimates that such hospital admissions dropped by 8% in 1999 because of the introduction of Cox-2 inhibitors, even as overall hospitalizations increased in line with an aging population.
This still doesn't make the drugs an easy sell to insurers: If every rheumatoid arthritis sufferer were on a Cox-2, the cost would be about $400,000 for every hospitalization avoided, and $30,000 if restricted to those at highest risk of bleeding ulcers. But Cox-2s would be an even harder sell to the average patient who'd have to pay, say, an additional $50 per month to cut his already small risk in half.
Yet this also points to a corollary that didn't make it into Mr. Gilmartin's statement. Several million potential patients would have remained who might have had no hope of arthritis relief except from Vioxx. Had a value-smart consumer been enlisted long ago to sort out who should really be taking Vioxx, he would have had an unimpeachable case for leaving the drug on the market, albeit with an expanded warning label.
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