Demystifying Medicine One Month at a Time

Category: medication (Page 2 of 3)

Medical ‘Reversals’

Twenty-five years ago, the New England Journal of Medicine issued a report on a stunning new medical discovery: Aspirin helps prevent heart attacks.

Yes, good ol’ aspirin. Known since the time of Hippocrates for its magical abilities to quell fever and pain, it took only 2000 years for us to understand the science of it well enough to design a ‘sufficiently powered’ double-blind, placebo-controlled randomized trial on aspirin’s efficacy in preventing heart attacks. The Physicians’ Health Study, so named because the study subjects were randomly selected physicians from across the U.S. (whom it was correctly assumed would have higher adherence in swallowing daily pills), addressed the question of whether or not aspirin has true live-saving benefit.

It does. Citing aspirin’s “extreme beneficial effects on non-fatal and fatal myocardial infarction”—doctor speak for heart attacks–the study’s Data Monitoring Board recommended terminating the aspirin portion of the study early (the study also looked at the effects of beta-carotene). In other words, the benefit in preventing heart attacks was so clear at 5 years instead of the planned 12 years of study that it was deemed unethical to continue blinding participants or using placebo.

week_in_reverse3Confusingly, there is now strong evidence that what’s beneficial for hearts can be harmful in eyes: older people who routinely take aspirin are nearly three times as likely to develop macular degeneration than non-users. Macular degeneration is the leading cause of blindness in Americans 55 and older. It presents a vexing medical problem, in that once it’s discovered, it’s too late to do anything about it. Macular degeneration afflicts more than ten million people in the U.S., which is likely an underestimate of its true prevalence.

What we see in this situation is a classic story arc in modern American medicine: Wonder-drug saves lives. Study stopped. Practice adopted. Then, years later: wonder-drug causes harm. Edicts to stop prescribing it, or be much more selective about recommending it.

Adam Cifu, a doctor (and former colleague) at the University of Chicago, has written about the concept of “reversals” in 5741medicine. In a fascinating paper, Cifu and colleagues catalogued several examples of new knowledge leading to “abandonment” of mainstream medical practices. A major example is hormone replacement therapy for post-menopausal women. For decades estrogen was given to American women as an elixir for many ills. All of the data in support of the practice was observational–outcomes conformed neatly to expectations about the drug. When good science (a randomized, controlled trial called the Women’s Health Initiative) finally challenged the practice, it was almost entirely abandoned.

I asked Cifu for a prediction about the near-blanket recommendation to people of a certain age to take aspirin, which is prescribed so widely, including to many who do not actually have heart disease or elevated cardiovascular risk. In an email, he wrote:

The [Physicians’ Health Study] never showed mortality benefits but only benefit to lesser outcomes – such as [heart attack].  Even in the earliest studies there was evidence that the benefit was only in limited populations, older ones, and was balanced by significant risk of bleeding (GI [stomach, etc] and CNS [brain]).  I think what has happened is that as the scope of the trials have expanded in terms of both patients and endpoints, we have gotten a more nuanced view.  Certainly the idea that [not] everyone over 40 should be on aspirin is a reversal but we will probably always be giving prophylactic [aspirin] to a subset of patients.

Got that?

One thing seems to be sure in medicine: if we just wait long enough for excellent science to guide us ahead, things we trust as ironclad rules often change.

Pills. Lotsa, lotsa pills.

Ever get confused over the names of medicines?

I do. There’s Zantac. And Xanax. Zanaflex; Zaleplon.

But Zanaflex is also known as tizanidine. Tizanidine functions very differently than Zantac and it’s other name, ranitidine, even though they sound alike.pill-man

Every drug has (at least) two names—one proprietary, and one generic. Proprietary names are created to sound catchy by the original manufacturer, almost always under a patent. The generic names are more like chemical names, in that drugs of the same class that are similarly purposed will have common suffixes, like the cholesterol controlling pills known as  ‘statins’, or the cardiac medications known as ‘beta-blockers’ (whose names end with ‘-olol’).

As Theresa Brown points out in her most recent “Bedside” column, this is a recipe for disaster.

One way to cope with this issue in the medical world is to insist on the use of generic names. One of my professors used to do that. If a medication’s trade name was used, he would insist he’d never heard of that drug.

Medical journals, though chock-full of proprietary-named drug ads, insist on generic names in their scientific articles. Better to separate the wheat from the chaff.

One addition to Brown’s piece: There’s lots of confusion over generics, too. Since any drug manufacturer is able to make and sell generics, multiple companies can make the ‘same’ medication though the pills (because of the ‘inert’ additives) might look entirely different.

I riffed about this previously, and the harm it caused a patient of mine.

Why not mandate a standard pill size/shape/color for generics and minimize the likelihood of error?

Aspiversary

Twenty-five years ago this month, the New England Journal of Medicine published a special report on something that’s become medical gospel:

aspirinAspirin.

That’s right. Not as in “take two and call me in the morning,” but in the realm of the randomized double-blinded placebo-controlled trial. Or what we generally consider the gold standard of evidence in medical research.

If you’ve often heard that bit of jargon but always wondered why it’s so exalted, break it down:

  • randomized: the assignment of the treatment (aspirin) or placebo (‘inert’ sugar pill) is not given in any planned sequence.
  • double-blinded: neither the researchers nor the subjects know who is taking what (everything is coded so that analysts can find out at the end).
  • placebo-controlled: the study compares the treatment against placebo to see if it’s helpful or harmful.

Even though acetylsalicylic acid’s properties as a pain reliever and fever reducer had been known in the time of Hippocrates, it was in 1899 that Bayer first patented and marketed what came to be known as aspirin worldwide.

A mere 89 years later, researchers from the “Physicians Health Study” did something unusual. Citing aspirin’s “extreme beneficial effects on non-fatal and fatal myocardial infarction”–doctor speak for heart attacks–the study’s Data Monitoring Board recommended terminating the aspirin portion of the study early (the study also was looking at the effects of beta-carotene). In other words, the benefit in preventing heart attacks was so clear at 5 years instead of the planned 12 years of study that it was deemed unethical to continue blinding participants or using placebo.

Turns out that aspirin inhibits platelets, tiny specialized blood cells whose job it is to stop your cuts from bleeding. In heart attacks, platelets clump inside the arteries of the heart depriving the heart muscle of vital oxygen. Using aspirin to inhibit their function is a key mechanism of preventing this phenomenon.

The amazing thing is that it took decades to organize an elegant and simple enough study with enough power (statistical heft) to show that good ol’ aspirin could really make a difference.

And that it was “just” aspirin. Shows how far we have yet to go in building medical knowledge.

Dispensing Docs

An article in the NY Times sheds a little light in a dark corner of medicine, the world of workers’ compensation. In particular, it highlights a world of doctors that dispense drugs in their offices, which improves both patient satisfaction and profit$.

My office is slightly better organized than this…(and we don’t dispense drugs–samples or otherwise…).

Though fraudulent insurance claims are always easy headline-grabbers (see here for an example), the real world of workers’ comp is complex and not always so tailor-made for sound bites. [See here for a PBS counterargument stating that 98% of claims are legitimate.]

Add to this mix the medical industry’s role.

Doctors in practice loathe disability evaluations. They are time-consuming and require several pages of documentation. After more than a decade in practice, I still fear the repercussions of these assessments.

I’m inclined to want to advocate on behalf of my patients, especially when I know them and trust their stories. But:

  • What if the patient is malingering and I’m unable to ascertain that? That makes me feel as if I’m party to fraud.
  • What if the patient is truly disabled and my assessment fails to further their claim? That makes me a failed advocate.

Primary care doctors typically have no specialized training in conducting disability evaluations, and even less understanding of the byzantine world of workers’ compensation.

As a result, most insurance companies now make claimants get evaluated at specialized occupational medicine centers, where the practitioners know exactly what to test for and how to document it to the satisfaction of the insurance companies. Yet there are always unintended consequences to this.

One example, as pointed out in the Times article, is that private equity funds have invested in companies that package or distribute drugs to doctors’ offices. It seems that practices specializing in the business of workers’ comp are particularly suited to be recipients of this investment.

What could private equity be doing in this realm, you ask?

Let’s just say they’re not in it to carry on the traditions of Hippocrates; rather, they see a handsome profit opportunity.

Turns out that most states (43 of them) allow doctors to dispense drugs, and in addition set their own prices on the medication. A handsome mark-up opportunity is thus enabled!

Don’t the patients see through this price-gouging, you ask?

Here’s the rub: Most of the time, health insurance (particularly the company’s workers’ comp insurance) foots the bill. So the patients don’t care! They’re just happy to get medicine as soon as possible after having been evaluated. Besides, so what if the overcharging sticks it to the workplace in which the patient was injured?

Some states have recognized this naked profiteering for what it is. Amazingly, California and my home state of Oklahoma are two of the states that have passed laws forbidding the huge markups.

Let’s face it: When the governments of these two vastly different states are both calling out corruption, you can bet there’s something rotten in Denmark going on.

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