Random Thoughts from a Restless Mind

Dr. Darrell White's Personal Blog

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Posts Tagged ‘eye drops’

Hoisting Another White Flag: Generic Medications

The great Dick Lindstrom recently posted an editorial on the challenges faced by doctors in a world that is focused solely on the cost of medication, one in which pressure is brought to bear on both doctor and patient to use an inexpensive generic at all times. Dr. Lindstrom reaffirms his career-long position that only one factor matters in the complex decision making process that is medicine: what is best for my patient’s health is my sole concern. Indeed, it is important for each physician to fight for this outcome, to fight for the person who sits before us in the exam chair or beneath us on the operating table. When a clinical difference exists between the expensive branded medicine and the cheaper generic we are honor and duty bound to prescribe and support the better medicine.

Sigh. It’s just all so tiresome, this battle. We physicians certainly did not choose this fight, and frankly most of us have no dog in the fight other than the best interests of our patients. I wrote PREVIOUSLY that the notion that pens, penlights, and candlelight dinners prompt doctors to become shills for pharmaceutical companies is farcical and offensive. Come on…I’m gonna look for a reason to prescribe some new eyedrop because someone dropped off a couple of pens? That’s all silly enough, but the battle has escalated with the entry of insurance company and government programs that automatically switch to a less expensive “therapeutically equivalent” medication and then require doctors to personally run the gauntlet necessary to “justify” their clinical decisions.

We are on the receiving end of the same kind of stuff that big companies use to defeat smaller foes in court: we are bombed with paperwork. Not only that but it’s carpet bombing, indiscriminate deluges of time bombs meant to bludgeon doctors into submission. There’s collateral damage, just like in carpet bombing, only the casualties are more subtle. Forcing doctors to be a part of this irreparably damages the doctor-patient relationship, making it more of a commercial interaction as doctor becomes ombudsman for patient.

As Dr. Lindstrom exhorts, I’ve been fighting the good fight. Dr. Lindstrom doesn’t need this fight. He’s a living legend who has earned the right to stand aside from these types of petty issues and to choose to put his considerable gravitas to work on stuff that has to be more fun. Yet he willingly takes on this battle and I’ve followed his lead. Standing my ground and insisting on newer branded meds when they are superior to older, cheaper generics. It’s getting to me, though. I’m tired. My staff is tired.

I surrender. Up goes another white flag.

I’m going to surrender in the battlefield of Glaucoma. Why Glaucoma and not cataract surgery for instance? I’m tired and beaten up, but I’m neither a hero nor a coward, not a sentient nor an idiot;  I don’t need to be a seer, some kind of morbid Karnac the OK, to know the outcome for either cataract or Glaucoma. I’m declaring right up front what is going to happen, how it will affect my patients, my staff, and me, and what the ramifications will be for American healthcare. I’m surrendering in Glaucoma because I can, continuing to fight in cataract surgery because I must.

In my 27 years as a physician only one paperwork/government regulation/billing issue has ever resulted in better care of my patients: the requirement to do an extended Review of Systems for a particular kind of visit resulted in the identification of major side effects from glaucoma eyedrops. Indeed, this was a total surprise and led to a rapid change in the way we took care of Glaucoma patients. Older medications, effective or not, were replaced by newer medications or laser because the newer treatments were both more effective and freer of side effects. What will I find this time?

Timoptic (topical Timolol) was introduced in the early 1980’s. It was a Godsend. Nothing less than a miraculous savior of vision, keeping legions of patients out of the operating room and saving thousands and thousands of people from certain blindness. It’s been off patent for decades but is now no more than a third line treatment. Why? Tons of side effects, some subtle (decreased exercise capacity, erectile dysfunction) and others less so (my friend essentially killed his very first Gaucoma patient in year one of the Timoptic era by prescribing Timoptic and causing 1st degree heart block). It’s really cheap now, but who can write this Rx and look themselves in the mirror, white flag or not?

We know that the Lipid class of Glaucoma eye drops is the most effective group of pressure lowering medications. The original, Xalatan, dethroned Timoptic in less than 2 years. Lower eye pressure and no systemic side effects and a new treatment paradigm was nigh. The worst side effect was a permanent darkening of the iris in 9% of patients, the price to pay to save your vision. Xalatan is now available as a generic (latanaprost). There are 3 newer, stronger, more effective Lipid medications, all of which are branded and all of which are 2-4X the cost of latanaprost. They all reduce eye pressure on average 2-3 points more than latanaprost.

I’ll start here. Starting next week every new glaucoma patient who opts for medical treatment will start on latanaprost. On top of that I will change every patient on a branded lipid to latanaprost if they risk losing insurance coverage for their drop. I will not respond to any insurance company challenge. If pressure reduction is inadequate I will follow my standard protocol and I will offer a second medication or glaucoma laser treatment, both of which are standard of care. If a second medication is chosen I will write for the generic second line Rx, an alpha-agonist. The generic and the brand alpha-agonist have equal efficacy; the generic has a 35-40% unacceptable side effect rate compared with the brand’s 10-12%. The generic cost is ~1/4 of the brand.

My staff and I will take the time necessary to inform my patients of these side effect issues, a time investment that will be a laughably small fraction of the time it takes us to fight the paperwork wars for Brand coverage. I will document this up the wazoo, noting every treatment failure and every last little side effect, jotting down every incidence of patient non-adherence. I will gear up for more glaucoma surgery, both laser and incisional, because I remember how much more of both I did in the days when Timoptic was king, in the days when version 1.0 of today’s medicines was so hard to take due to side effects. I will have this all on hand when we start to read of the new golden age of Glaucoma surgery.

I will be ready to answer the critics who accuse eye doctors of doing too much Glaucoma surgery.

The Subtle, Cynical Rationing of “Good Enough”

It took exactly one week. One whole week before we had our first adverse reaction to the not-so-new new generic eyedrop. Not a one of us was surprised because we’d been here before. The branded version of this particular medicine, version 1.0, did the same exact thing. Thankfully, branded version 2.0 and 3.0 worked like a charm with pretty much no side effects. Yup…one week forward to end up 7 years in the past. Our own little front row seat for the spectacle of the subtle, cynical rationing of “good enough”.

We’ll see more, of that I am sure.

Let me share the back story here before I expand and move on. In eye surgery, specifically cataract surgery, there is a very inconvenient complication called “Cystoid Macular Edema”, swelling of the center of the retina also known as CME. As a natural phenomenon it occurs in 6-9% of cataract surgeries, and unfortunately it occurs even in people without any risk factors who had perfect, uncomplicated surgery. However, if you treat cataract surgery patients with a Non-Steroidal Anti-Inflammatory Drug (NSAID), kind of like Motrin in a drop form, you decrease the likelihood of CME by a factor of 10, down to 0.6-0.9%. Wild, huh? A real no-brainer. A classic example of that chic and trendy outcome-based medicine thing, especially since CME is costly to treat and very scary for the patient.

This 10X decrease originally came with a cost, however. The original versions of these NSAID drops stung and burned, and some 30% of patients had swelling and inflammation in their cornea which caused a temporary DECREASE in vision. So, stinging and burning which reduced the number of people who actually took the medicine, and an inflammatory side effect that decreased vision and forced you to stop the medicine. Tough call. But we live in America. Lo and behold out come versions 2.0 and 3.0 which still have a 10 times decrease in CME, only this time without any stinging or burning, and without any inflammation and decreased vision. BINGO! Another no-brainer, right? Same benefit with pretty much no side effects. Sure. Easy. Right up until a generic of version 1.0 comes out. It took exactly one week to be reminded why 1.0 was bumped by 2.0 and 3.0.

It’s like they used to say in Amish country when my wife was a kid: it’s good enough for who it’s for.

And there’s the rub, of course. Right now it’s for “them others”, but eventually it’ll be good enough for YOU. That’s the whole name of the game with this rationing stuff, you know. All you have to get to is “good enough” and then the only thing that matters is cost. No consideration for compliance, convenience, or quality of life, the only consideration on the board is cost.

Why does this matter? Isn’t the cost of medical care in the United States the single greatest fiscal challenge facing our local, state, and federal governments? Simply put, yes, the cost of caring for an increasingly unhealthy population is, indeed, getting out of hand. Rationing based on “good enough” is based on a very superficial analysis of this problem, however. This is part of the cynical aspect of this type of rationing, because a true effort at cost containment demands a deeper root–cause analysis of the “why” it’s getting so expensive. “Good enough”, by its very nature, brings healthcare to at best a standstill, and as I noted above generally involves rolling back the clock.

Reasonable people have asked why this isn’t actually, truly, good enough. In truth, what we have available to treat diseases today, or even stuff available in 2003, is at least one full order of magnitude better than that which is available in second and third world countries today, or available in first world countries in 1975. Why WOULDN’T this be good enough? Well, how do you think we got where we are today? We did so, of course, by always seeking BETTER. Not only that, but at least in America we did so by always seeking better for EVERYONE. Even “them others”.

Rationing is the great chameleon of health care cost reduction. It’s not just the forced use of generic medications (some are actually exactly equivalent to their branded counterparts) but it takes many other forms as well. The effective denial of access to both primary and specialty care for those individuals “covered” by Medicaid. The myriad, byzantine rules and regulations that are so opaque that individuals throw their hands up in disgust and dismay and fail to seek care for fear of the financial consequences of doing so. Scarcity of resources which is either real (there is an inadequate number of neurologists practicing in the United States), bureaucratic (operating room privileges for specialty surgeons are limited by governmentfFiat in Canada), regulatory (exciting new uses for established medications go undiscovered because of FDA gag rules). or arbitrary ( payment for cataract surgery is denied if the visual acuity is not decreased to a particular level regardless of how it is affecting an individual’s life). Seriously, I could go on and on.

“Good enough” is okay, I suppose, if it is used as the floor beneath which we will not allow healthcare to fall. It’s okay if that floor is constructed by carpenters whose only consideration is the real “boots on the ground” outcome from that healthcare, NOT people whose major concern is cost alone. Finally, it’s really only okay if that floor is actually the floor of an elevator, always and ever moving upward, because even “good enough” has to get better. Every example of “good enough” is actually the result of some yesterday’s healthcare breakthrough. Some yesterday’s effort at achieving “better.” Every version of “good enough” is actually trickle-down “better”.

“It’s good enough for who it’s for” is all well and good as long as you remember that, eventually, who it’s for is you.