Heartfelt with Dr Melissa Walton-Shirley

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ATLAS ACS 2-Where do we stop?

Nov 13, 2011 22:53 EST


Last week, a patient told me I had cost her an extra $360 per month. She lives on a fixed income and suffers from angina. She has hypertension, diabetes, and dyslipidemia. With the simple stroke of a pen, I added a new medication and I changed her life, but maybe it's not been such a good thing. She can no longer comfortably have a night out with her granddaughter. She will be more careful about what she purchases at the local grocery. Christmas will be different this year because in three months, she'll spend an extra $1080 dollars on her medication. In today's ATLAS presentation, the antithrombotic rivaroxaban lowered mortality when added to aspirin and clopidogrel, and I couldn't help but think about what my patient had said. Although I was thrilled to see a positive result in the world of secondary ACS prevention, just where is all the madness going to end?

During the 1960s, heart-attack treatment and prevention of reinfarction was deplorable. It consisted of bed rest and chicken soup. Then came nitro, aspirin, and later, heparin. Beta blockers and statins were then added to our armamentarium. We lurched light-years ahead with CABG. Finally, the appearance of the mightiest of the mighty therapies: PCI came into our midst kicking and screaming, flexing its muscles and burrowing its way into the world of ACS with balloons, wires, and stents. All of this came at a price, but we physicians are rarely aware of exactly how much of our patient's money we are spending for them.

Like a snowball rolling down hill on a particularly good day for packing and shaping, the veritable laundry list of drugs for our patients potentially adds a new layer of pharmaceuticals each year or two. We now have "add-on" meds like aliskiren, soon the CETP inhibitors, and now potentially low-dose rivaroxaban for its new indication for ACS.

There is little doubt that the planning has been extensive for the sale and marketing of this drug. There is also little doubt that our US patients will likely pay for both the development and the world's supply of this medication. At what point will a battle-worn US patient revolt, weary from the financial burden we have thrust upon them? But aren't they revolting already and not telling us?
Study after study has demonstrated that compliance at its best is around 50%. I used to think it was just hardheadedness, lack of dedication to good health, or lack of education that drove that statistic. Now, in this environment of economic despair, it is also the lack of funds that dictates who buys what and when. Intelligent, sophisticated patients are literally begging for mercy every time I write a prescription.

At some point, someone is going to have to own the process and ask when it's time to go backward and delete things from our medication list that might no longer be needed. Someone has to decide which things are antiquities and which medications have retained their relevance.

In deep winter, on a snowy day, we layer up with coats, shirts, long johns, hats, scarves, and gloves. But when we come inside, into a different environment, we have to shed some of that insulation. If we don't, we could easily overheat to the point of becoming ill. It's time to examine the possibility of shedding some of the old pharmaceutical clothing that is suffocating our patients. Dr Paul Armstrong from the University of Alberta even questioned if one "needs to subtract aspirin" from our patient lists in this era of cardiovascular polypharmacy.

One can never know where they are going unless they know exactly where they have been. We've come a long way to get to this point. ATLAS ACS just might get us thinking in a better direction.

See also:

ATLAS ACS 2: Low-dose rivaroxaban looks good in ACS








Your comments
ATLAS ACS 2-Where do we stop?
# 1 of 5
November 14, 2011 09:11 (EST)
Glen Brizendine

Awesome read Dr. MW-S.  So, so true and I live in the world of industry.  The crying shame is the lack of patent enforcement that US companies are afforded abroad, which in my view results in the US population footing the bill for the rest of the world (as you stated in your article).

 

# 2 of 5
November 14, 2011 08:59 (EST)
Dan Hackam

Maybe better primary prevention would help?  Question: how did this lady become dyslipidemic, hypertensive, diabetic and anginal in the first place?  Answer: through decades and decades of plaque accretion caused by poor habits in the context of poor genes.  Now you are seeing her in the last decade or two of her life - when health costs are known to soar - and because of positive RCT's, we have to pile on with lipitor, aspirin, plavix, coreg, altace, metformin, actos and now xarelto.  Note that all of these drugs have mortality benefit data so how do we pick and choose between them?  The RCT's don't help with that, so I do not see the latest trial as getting us thinking in the right direction, as you stated.

Even in the secondary prevention setting, do we need more antithrombotics in CAD/ACS? At what point are we going to take care of eliminating the nidus for future atherothrombotic events? Intensive risk factor control would do that. Getting lipids to unheard of very low levels, together with BP and blood glucose, physical activity, smoking cessation, diet, would pretty much eliminate the need for a third antithrombotic substance such as xarelto (just look at STENO-2).

But the other way to look at this is akin to antineoplastic therapy for cancer. No one questions the need for a cocktail of 3 or 4 or 5 toxic therapies for such a serious disease as cancer. Isn't CAD also a life-threatening disease? Isn't it also lifelong?

Just 3 perspectives from 1 person. 

# 3 of 5
November 15, 2011 12:24 (EST)
Bryan

Wow, finally! I'm a bit of an odd Pharmacist in that I've been saying for a long time that adding all these drugs is not the right answer. With compliance issues being what they are, would we be better off if we got 100 % compliance of an ASA a day. Rather than 30-50 % complience of a 2-3 drug regimen. Not to mention the increased quality of life with an extra $360 or more/month. The recent Free-MI trial pretty much proved that you can take a horse to water, give him the water, tell him how important water is and it doesn't matter 67% of the time.

I do understand though that physicians are compelled to try to treat all of these folks issues. They are also held liable if they do not. But that does not mean it's the best thing to do.

# 4 of 5
December 2, 2011 04:08 (EST)
Bill

One way to analyze studies is to assess the overall outcomes of things that are in the "good" and "bad" column. The primary endpoint of having MI, stroke, or death plus fatal bleeding. I am sure everyone can agree that dying is a bad thing. There is too great a reliance upon RRR, HR, OR and NOT absolute differences for the "benefit" of a drug.  Adding the primary outcome plus the worst adverse effect gives a 1.7% absolute difference for 2.5 mg and 5 mg doses of rivaroxaban.  This can be compared to the 7-7.4% of patients NOT getting a thienopyridine and between 1.3-1.5% who did not get aspirin (as stated they did in the methods). Also, statins were not given to 16.1 to 16.4% of the patients. This is clearly below any standards of care. The authors should inform the readers if these differences mattered to the outcome.

 

One can also reverse the equation when assessing data and ask what % did not have an event (avoiding the primary enpoint PLUS fatal bleeding) and find those numbers of 2.5 mg, 5 mg, combination, and placebo were 90.8%, 90.8%, 90.8%, and 89.1%, respectively. The rate of fatal bleeding was higher in the 5 mg group than 2.5 mg and placebo. MANY patients would say these are not very different results.

 

Asking how much of a difference makes a difference is something I was taught a long time ago. I am not sure this is a huge difference, despite the p values! 

# 5 of 5
December 4, 2011 10:58 (EST)
Avinash Murthy

I am glad we have come a long way from chicken soup and bed rest. The compliance issue has been a bane for sometime now, but that is not the reason not to use medications which we think serve better, particulalry after ACS. Patient economics is an important consideration, but as a practioner it is difficult to shy away from prescribing medications we think works.... being a good doctor is certaainly more than writing prescriptions. 

I am not sure which new drug costs 360$ a month in the managment of angina, but it is difficult to understand why doctors write prescriptions without giving the patient heads up about how much it would cost and verify with them if they can afford it.... this piece serves as a good reminder to check with the patient every time we write a new precription if they can afford it or not. 

 


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About Dr Melissa Walton-Shirley
Dr Walton-Shirley performs invasive cardiology, nuclear cardiology, and stress echocardiography in a private practice in Glasgow, KY.

Her chief medical interests are CHF/hypertrophic obstructive cardiomyopathy and the promotion of primary PCI for acute MI. Recently she played a significant role in helping to launch an ambitious pilot study of primary PCI in Kentucky, the Kentucky Primary Angioplasty Pilot Project. She has also participated in the TIMI 19, Duke-HF, NRMI, and CRUSADE trials and is proud to have been an advocate of the first smoke-free initiative in Kentucky (2011). She champions a smoke-free America.

Dr Walton-Shirley received her undergraduate degree at the University of Kentucky and went to medical school and did her residency and fellowship at the University of Louisville. She is married with two daughters. Her interests include singing, writing poetry and songs, fitness, and, of course, theheart.org.