Category Archives: Health Care Economics

A Patient’s Confusing Journey Into The Quagmire Of Cardiac Imaging: A Cautionary Tale

Mary-Ann, a reader from the north,  provides today’s post. Her story illustrates how easily medical care can veer off the rails while it is simultaneously railroading patients.  It is a cautionary tale with wisdom that can help most patients.

In this post I’ll just present Mary-Ann’s perspective and solicit responses.  Down the line I’ll provide some perspective on the processes, the problems and the solutions.


It started innocently enough. I showed up for a regular visit with my cardiac provider, a mid-level professional. She noted I was flushed and had a high pulse — about 100. 

Starbucks, I explained, and I flush easily — always have. She looked skeptical.

That is how I went from a half-caf Americano to a 48-hour holter monitor.

I went back for results — the usual ectopic beats but nothing scary or new. But again, she noted I had a fast heart rate and I was flushed.

And once again I explained: Starbucks — it is right down the street and okay, I might have a problem.

That is the short — but highly accurate — version of how I wound up getting a stress echo. 

I showed up for the results of the echo and that is where the runaway train started down the tracks.

“…possible inferoapical wall hypokinesis with lack of augmentation of systolic function, which are abnormal findings and may be indicative of ischemia due to underlying coronary artery disease. EF was 56% at rest and 40-50% at stress.” 

Wait — what?!

I was marched down the hall and scheduled for a cardiac angiography — and told not to run any marathons in the intervening two days. 

Marathon?! I was terrified I was going to drop dead at any moment. I contemplated just sitting the waiting room for 48 hours — just to be safe.

Then I started reading the professional literature and things were not adding up. An EF at stress of 40 – 50% is not good — in fact, it can be heading into heart failure land.

But I was active and fine — it did not make any sense.

I called the office; my provider was not available. I explained that I was worried there was a mistake. Oh no, I was assured, they are very careful to not make mistakes.

I wrote my will. I cried a lot. 

And when the person called to remind me of the procedure (like I could forget!?) I once again explained that I was worried there had been a mistake, and once again — reassurance. No mistake.

Nevertheless, she (aka me) persisted!

I sat on the hospital bed in nothing but a gown and handed the nurse my two-page letter; it started like this:

“I am reminded that what is normal and ordinary for a professional is never that for a patient. I am terrified.

First, I want to be really sure that there is not any chance of a mix-up in the stress echo test results. This is not simple denial or wishful thinking…” 

And that nurse paid attention, which is how I wound up not having a cardiac angiography. 

The cardiologist scheduled to do the procedure — we shall call him Doc #2 — wrote: 

“She has some concerns regarding the results of the stress echo study … I reviewed the most recent stress echo and it appears to me that the results for the resting versus the stress echo ejection fractions have been transposed…”

Translation: A Typo.

I was elated! Jubilant! We went to Starbucks to celebrate.

The giddy joy quickly turned to something along the lines of WTH just happened here? I read the original echo report written by Doc #1 — that lit the tinder. There were two different values for EF at stress documented in the report, and another sentence that was repeated. 

The professorial side of me was deeply affronted — in a subsequent meeting with hospital administrators I confess to saying that someone who is making hundreds of thousands of dollars a year doesn’t get to write such a sloppy ass report — and about someone’s heart, no less! 

But the best part of that meeting was learning that Doc #1 denied there was a typo — he stood by his findings. 

Oh dear.

And Doc #2 stood by his findings as well. And Doc #3 got involved somewhere along the way and he agreed with Doc #2. And the mid-level Provider also agreed with Doc #2.

The majority rule seems like an odd way to make health care decisions — wouldn’t you think all those smart people could talk among themselves and agree?

Apparently not.

That first meeting with the hospital folks included all manner of solicitous apologies and an attitude of collaboration. Of course, they said, we can send the echo to an outside cardiologist — at our expense — and get an answer.

And then I made the unthinkable mistake — and I blame the Skeptical Cardiologist for this — of asking informed questions.

“Are the cardiologists involved in reading my echo Level III echo specialists?”

“I understand that there can be variance in estimated EF between cardiologists — what level of variance is considered acceptable?”

The hospital team responded to my questions by calling a meeting — and the tone had changed considerably (Thanks a lot, Corporate Legal).

The offer to pay for an outside opinion was off the table — after all, they said, you would not have a patient-provider relationship with the cardiologist reading the echo. Ahem, I noted — I have zero relationship with the first cardiologist who read the echo and would not know him if I bumped into him at Starbucks. And you all did offer to pay for that outside opinion…

Oh never mind those minor details. No outside opinion on their dime. They would do a Lexiscan at their expense as a tie breaker. Final Offer.

Tiebreaker — really?! Is this a soccer game?

And seriously — should I have to have an invasive test to settle THEIR disagreement?! [Note: If it involves needles, it is invasive.]

Because there were not enough cardiologists involved already, I saw yet another one — from a different practice. He offered that the EF at stress looked more like 55%, placing his bet smack in the middle, and recommending a CT Angiography Coronary Arteries with Contrast as the tiebreaker.

Tiebreaker. That word implies both sides are equivalent or equal. However, my heart is not actually a game and the two teams cannot both be right — there is no equivalency in play here. What we are really trying to do involves accuracy — not breaking a tie score.

But I digress.

It doesn’t seem like you should have to make a chart to keep track of what cardiologists say about the same echo but in this case, it seemed necessary.

 And in the meantime, yet another cardiologist weighed in that the quality of the echo was poor — and no wonder they could not agree.

Deep breaths.

And so, for the past four months I have tried to navigate all this, and to understand what this actually means about cardiology and medicine and so many things. My confidence and my mind have been blown. Resources – and time – have been wasted. 

Ectopic heartbeats are typically benign in a structurally normal heart — I thought I was safe. But I have not felt safe since that day when I learned that Doc #1 and Docs #2, 3, and so on had decided to have a stand-off at the OK Corral that is my heart.

Except, I do not know if it is okay. And that is the problem. 


Unfortunately, Mary-Anne’s tale is not uncommon. It touches on many of the areas that patient’s should be aware of including

-Undergoing diagnostic imaging testing when you are free of symptoms

-Inadequate quality control in diagnostic imaging and how that leads to false positive results

-Variance in imaging performance and interpretation-how the same test can be read as normal by one doctor and markedly abnormal by another.

-The tendency of some cardiologists to recommend invasive testing when it is inappropriate and likely to cause more harm than good

-The importance of second opinions, especially if invasive testing is recommended

-The importance of patient’s doing their own research and asking good questions based on that research.

Transparently Yours,

-ACP

Where Are My Generics Medications Made? India, China, or the US?

With the recent recall of valsartan due to carcinogenic Chinese contaminants the issue of where one’s generic medication is manufactured has become more important.

I take two generics: ramipril for my hypertension and rosuvastatin for my cholesterol/atherosclerosis and I had no idea where they came from when I discussed the rise of generics manufactured in China recently.

Where Is My Ramipril Made?

I called my St. Lukes pharmacist, Robert, and asked him if he could give me information on the origin of these pills.

Robert told me that my 10 mg ramipril capsule was distributed by a company called West-Ward located in New Jersey.  West-Ward was an independent Columbus, Ohio company but was purchased in 2016 by a very large pharmaceutical company , Hikma, based in Aaman, Jordan. Now the Hikma web site indicates West-Ward is no more and is simply called Hikma in the US.

According to a 2017  Columbus article

Hikma Pharmaceuticals Plc projects it will end 2017 with about $2 billion revenue, about $600 million of which is from generic drugs made by its U.S. subsidiary West-Ward. In the spring, the company had projected $800 million in generics sales.

Customer service at Hikma informs me that my ramipril was made in their Columbus, Ohio plant.

Where Is My  Rosuvastatin Made?

My rosuvastatin (generic of Crestor) was made by Glenmark Pharmaceuticals which, per wikipedia

 is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons.

Glenmark received FDA approval to market their generic rosuvastatin in the US in July, 2016. and at that time had 115 products authorized for distribution in the US market and 61 drugs pending approval with the US FDA.

My rosuvastatin according to Robert was made in India although the Glenmark product catalog does not reveal this information.

Generic versus Brand Name

I’ve talked about Crestor/rosuvastatin a few times on this blog and the development of a generic version has been very helpful for many of my patients. Looking online today I see that generic rosuvastatin goes for about 10$ per month compared to 260$ for Crestor.

Is it worth paying an extra 250$ per month to get brand name Crestor if, let’s say it was manufactured in the US? For most people it isn’t. For one thing, there is no guarantee of where your brand name drug is manufactured.

Crestor used to be made in a factory in Bristol, UK but this was shut down in 2017 and now I can’t tell where Astra-Zeneca makes the stuff. Frankly, I’m surprised that they are selling any of the drug which used to account for 5 billion dollars of their annual sales.

So my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio by a Jordanian company.

I never realized how globalized the pharmaceutical industry has become. Hopefully, the FDA is doing a good job of monitoring the safety and quality of products we rely on for our wellbeing which are manufactured all over the globe.

Skeptically Yours,

-ACP

Addendum: I have an updated post which includes more generic ARB recalls here

Is Your Generic Medication Made In China and Is It Safe?

Last week the FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen (see here.)

Since then I  have switched many patients from the bad valsartan to losartan or valsartan from presumably safe manufacturers.

It didn’t really occur to me that this could be just the tip of the iceberg until I received a reader comment which I will copy below.

As I thought about it, I realized that I have no idea where the generic ramipril I am taking is manufactured. It very well could be in China or India.

This recent article from The Epoch Times confirms that Americans are becoming more and more reliant on medications manufactured in China and that many researchers feel this poses a significant security threat.

The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all.

The book, “China RX: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh,” details the problem.

It is very hard to find out how many US drugs come from China since drug companies don’t make their sources apparent. In addition, even if the drugs themselves aren’t manufactured in China, Gibson and Singh write

“China is the largest global supplier of the active ingredients and chemical building blocks needed to make many prescription drugs, over the counter products and vitamins.”

Below are the comments of my reader:


This is horrible. We have a problem in the U.S. It is the infiltration of Chinese generics. I had no idea that this generic was being supplied by a Chinese maker. In fact, the bottles I got said “SOLCO” which is based in New Jersey. Now I’m painfully aware that SOLCO Healthcare US which is based in New Jersey, is owned by Zhejiang Huahai Paarmaceutical based in China’s Zhejiang Province. So this is the Chinese company’s subsidiary distributing this drug in the U.S. China has a long history of selling tainted products in the U.S. Chinese drywall, lead-based paint on toys, tainted pet food, etc. Now it is important to understand that 85% of prescriptions filled in the U.S. are generic. And insurance companies will not pay for brand when generic is available. My valsartan was about $30 for 90 days. Diovan is $750. I get it. But when these companies cut corners and people are endangered, something is wrong. I will never ever take another generic drug without first finding out where the product comes from. I know this is not perfect, but it is something. I think the U.S. lawmakers need to do something to make this information more transparent. It baffles me as to how this drug could have been tainted with a highly toxic chemical for so many years (they now say 4 years). This chemical is known to cause liver damage and cancer. Apparently the manufacturer changed the way it made the active ingredient which created this poison by-product. And now who do we hold accountable? How do we get to the bottom of what went wrong, and how to prevent this going forward. We have no way to compel anything in China. All that said, thanks for your information here it is helpful. I worry that the losartan is made by the same company – I will surely investigate.


China is also flooding the American market with useless OTC medications. I realized this when I looked closely at this “motion sickness patch” which is highly rated on Amazon.

It has no active ingredient which could be realistically thought to treat motion sickness yet is featured on Amazon’s motion sickness treatment section and is favorably reviewed by over a thousand users.

 

Unfortunately, in the US now users of medications must be very aware of the source and quality of the products they put in their body. Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Skeptically Yours,

-ACP

Addendum: I have a more recent post which includes additional recalls here.

US Health Care: Spending More But Getting Less Than Peer Countries Since 1980

Austin Frackt has a good article up at The incidental Economist discussing this graph:

life-spend

Why did the US become such an outlier; spending lots more per capita on health care but without demonstrable benefit?

A second graph shows how US longevity has not kept up with improvements noted in peer countrieslife-expectancy-1.jpg

Frakt touches on many of the proposed mechanisms for America’s divergence from the pack and the article is well worth a few minutes of your time.

Skeptically Yours,

-ACP