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Doctor behind $40 sepsis treatment critics call ‘hocus-pocus’

April 8, 2017

Sepsis can be unpredictable, fast moving, and fatal. The condition has been identified as the number one reason for readmissions and the most costly.

So, when a paper in Chest described patients who recovered with an infusion of steroids and intravenous vitamin C, it got a lot of attention, not all of it good.

The study’s lead author, Paul Marik, MD, a critical care physician at Eastern Virginia Medical School in Norfolk, VA, calls the study preliminary and agrees that more data is needed.

But he thinks the sepsis regimen is safe enough to start using now. HealthLeaders talked to Marik this week. The transcript below has been lightly edited.

HealthLeaders: What was the response to the Chest paper?

I did get some pushback from people who said, ‘you can’t do this.’ But actually, we can. Steroids and thiamine are highly available.

There is an enormous amount of literature on critically ill patients who have almost undetectable vitamin C levels. That is quite appropriate to replace. If you look at the package insert, it says IV vitamin C is indicated for patients with acute deficiency of vitamin C.

HealthLeaders: Are there side effects?

Marik: We were quite comfortable in doing this. In the dose we used, there were no side effects. You always have to be careful that there is no potential for harm. In the dose we use, it is completely and utterly safe.

HealthLeaders: What should hospital administrators know?

Marik: Patients will come to our ICU in septic shock. They will leave three days later with no organ failure. From the hospital’s perspective, this is very big.

They don’t go into renal failure, so there is less requirement for dialysis. The leave the ICU and the hospital more quickly and the length of stay is very short.

Their readmission rate is much lower; sepsis is a bad thing with all kinds of organ dysfunction. They leave much healthier.

Our (president) is delighted by this because he sees the real data and he can tell that the length of stay is down, the use of resources is down… the mortality is down.

He is ecstatic… This a no brainer and a win-win situation.

HealthLeaders: What are the costs?

It costs $40, which is less than that of an antibiotic. It shortens the length of stay, it doesn’t have all these complications, which are very resource-intensive and very expensive. And patients leave the hospital well.

HealthLeaders: Are there other benefits from the treatment?

Marik: There was a randomized controlled trial in hospitalized patients with low levels of vitamin C. Researchers looked at patient’s mood and happiness and they found that patient who got vitamin C, their mood was better and they had a higher happiness index.

So our motto is they leave alive and they leave happy.

HealthLeaders: Isn’t this an off-label use? Don’t we need randomized clinical trials?

Marik: I’ve got a lot of feedback because people think this is BS and hocus-pocus and unscientific.

It’s based on very sound scientific principles. This becomes important because we think, in our setting, it is unethical not to do it.

People say we need a randomized trial before we do it. This is what we are trying to do, and I’m trying to get other people involved, but that will take time.

To do a [randomized control trial] you need a lot of money and it takes three or four years… In the meantime, millions of patients are going to die while they wait. I say, what have you got to lose?

I have colleagues across the country who are using it, and they are telling me they are seeing exactly what we see. There are other people who just won’t do it.

I was in Seattle at a sepsis conference two days ago. The audience was half nurses and half physicians. The nurses thought it was the coolest thing in the world and were really excited and wanted to do it.

Half of the physicians thought was cool and the other half thought it was nonsense and they wanted more data. That’s where we sit now.

HealthLeaders: How did you come to do this study?

Marik: It was not my goal to find a cure for sepsis or anything else. When you have really sick patients, you have an obligation to them to do the best you can and to think out of the box.

This started last January. We had this 53-year-old lady who was otherwise previously well… It was clear to me that she was going to die from sepsis.

Dr. [Berry] Fowler from Virginia Commonwealth University had sent me a paper on stuff he had done on vitamin C… When I was faced with this, I remembered and thought, maybe I should try this.

I pulled out his paper to get an idea of the dose. I thought, why don’t I use steroids with it, because maybe they will work together?

The next day when I came to work, I was shocked to find that she was off all the vasopressor agents. She was extubated two hours later. Her kidney function improved. She left the ICU three days later.

So, we started using it cautiously in more patients and found exactly the same thing.

We thought we had an obligation to continue to do this because this is such a bad disease and [we] see patients turn around.

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