09.14.2006 The Amgen Rip-off (6 comments ) READ MORE: 2006, Washington Post, George W. Bush
Medicare spends more money on Amgen’s Epogen than any other drug in its medicine chest — $1.75 billion in 2005. Virtually all of it went to patients on dialysis. (The agency also pays for the same protein for cancer treatments, but those are sold under the brand names Aranesp by Amgen and Procrit by Johnson & Johnson.)

Given that level of spending, you’d think there would be pretty good evidence that this drug, which raises the red blood cell count, is delivering positive results for the unfortunates suffering from what the government and physicians euphamistically call “End Stage Renal Disease” (ESRD). The euphamism refers to the fact that the average life expectancy of a person who enters dialysis after their kidneys fail is about five years.
You’d think that but you’d be wrong. In fact, the evidence suggests just the opposite. Of course, treating the anemia associated with kidney failure was a godsend when Epogen first came on the market in 1987. It ended the need for blood transfusions, and allowed dialysis patients to have red blood cell counts (hematocrits) near normal.
However, the Food and Drug Administration’s initial approval for Epogen called for raising hematocrits to about 15 percent below normal. While most patients don’t notice the difference, Amgen, through a series of studies it funded, attempted to show that higher hematocrits were better for patients. Their measuring sticks? “More energy” and “greater alertness.” Through intense lobbying, they used those studies to browbeat Medicare into reimbursing dialysis clinics to raise hematocrits to slightly below normal. Not surprisingly, in the wake of that 1997 decision, Medicare spending on Epogen soared.
But what were the medical results of that policy? In a paper published in 2004 in the Journal of Clinical Epidemiology, Dennis Cotter of the Medical Technology and Practice Patterns Institute and his colleagues at Johns Hopkins and the Boston VA showed that attempts to reach normal hematocrits, which required LOTS more Epogen, did not correlate with increased longevity for people on dialysis. In fact, they showed that raising ESRD patients’ hematocrits to normal levels actually resulted in shorter lifespans because it increases the incidence of heart attacks, strokes and other cardiovascular events.
Gee. You mean thickening the blood in people who have severe microvascular distress from a lifetime of untreated hypertension and diabetes (which are the primary causes of kidney failure) causes heart attacks? To quote that famous line in Casablanca, I’m shocked.
Now, Cotter and colleagues are back in the latest issue of Health Affairs (subscription required), bringing us up to date on the Bush administration’s policy on Medicare spending for Epogen. In a move that NO ONE in the mainstream press covered (Hey, another half billion dollars in drug spending? Who cares?), CMS this past April gave dialysis clinics the okay to raise patients’ hematocrits to 39, which is normal for women and a shade under normal for men.
If Cotter’s earlier paper is correct, the end result of this policy will be shorter lifespans for many dialysis patients, but greater sales and higher profits for Amgen. To use the dry language of the Health Affairs study, “CMS has tacitly implemented a policy that does not appear to confer additional proven benefit to its beneficiaries.”
What would Cotter do about it? First, improve the evidence for drugs Medicare buys. Payment decisions should no longer be based on surrogate markers like the relationship between higher hematocrits and a subjective measure like “more energy.”
Second, the agency should require randomized clinical trials, systematic reviews and meta-analyses to prove that a drug it pays for results in better outcomes for patients. In addition, since the companies selling the drugs have a stake in the outcome, those trials, reviews and analyses should be conducted by physicians without conflicts of interest.
Finally, if CMS doesn’t have that kind of evidence generated in independent studies, it shouldn’t pay for any drug that has not been prescribed for an FDA-approved use and at an FDA-recommended dosage.
This past week, Bernadine Healey, the former head of the National Institutes of Health, launched a wrong-headed attack against evidence-based medicine in U.S. News and World Report. (For a good blog entry attacking her article, see Gavin Yamey’s latest posting on the PLoS Medicine website.) The Amgen-Epogen-dialysis saga is a perfect example of how ignoring the evidence is costing taxpayers a bundle.
Meanwhile, economic pundits like Robert Samuelson (see today’s Washington Post) rail against increased Medicare spending (even though its costs are rising at a much lower rate than overall health care spending, a fact I wish he had mentioned in today’s column).
But I agreed with his larger point, which is that uncontrolled health care spending (not just Medicare) will bankrupt the rest of the economy if left unchecked. But how should we rein it in? But cutting benefits and raising first-dollar coverage so people will simply stop going to the doctor for minor ailments and preventive care?
That would be a tragedy. What we need now are reporters in the mainstream media willing to go after companies like Amgen that rip off Medicare. Of course, we also need courageous editors willing to ignore the fact that the drug industry’s full page ads are a major prop in their shrinking bottom lines.
But that’s another story.

gleaned from the dialysis_support list (thanks Kim!)

What an eye opening article, and so objective! :)

Yeah, Epogen sure is a ripoff – nobody notices small increases in oxygen carrying capacity of red blood cells – that’s why so many cyclists utilize it to gain increases in their hemadocrits – because people can’t tell the difference.

Where this article fails (aside from its blatant bias) is in assuming that patient longevity is the sole purpose of dialysis. Just because Epogen isn’t prolonging life doesn’t mean it is a ripoff. In fact, I don’t think its use is for extending life, rather for improving quality of life, particularly for those dialysis patients still active in their lives.
For most of us, End Stage Renal Disease does not refer to our last stage of life, but our last stage of renal function. Most of do in fact notice a large increase in energy and alertness (I won’t use quotes the way the article does to suggest that these attributes are fictitious) with the use of EPO.
I think the real issue here, is not that Amgen is ripping off Medicare, but that Medicare is ripping off dialysis providers, and the providers are combating their losses by prescribing more epogen. Why not after all, Medicare is paying for more EPO, when it won’t pay more for dialysis treatments.

It takes less than two minutes.

Medicare is not just for seniors, it’s used by many people in different age groups and demographics – and for many it is their only access to life saving health care. Take me for example: I’m 29 years old, and un-insurable privately. That makes it really difficult to receive the life giving dialysis treatment I so desperately need.

Medicare pays for 80% of my dialysis treatment – that is – 80% of a number that is nowhere near what dialysis is worth.
Right now I think that number is somewhere around $130.00 per treatment.
The actual cost of treatment to the provider is several hundred dollars more.
That number isn’t made up – it’s based on actual costs to keep the provider running as a viable business.
Medicare though, has not changed its rate of compensation for something like 30 years, which is why the Kidney Care Quality Improvement Act is so important.
This act simply makes it possible for Medicare to pay dialysis providers more. Not more than they’re worth, but enough to actually keep up a decent standard of care.
You see, when the dialysis clinic has a bunch of patients with Medicare as their primary insurance, they lose money. In fact, they lose between $5 and $10 per patient per treatment. The obvious move for the business would be to disallow Medicare patients – but they can’t do that (thankfully). They do need fair compensation though. The result of this loss is the hiring of less staff members (we’re already well below what should be an appropriate staff/patient ratio). Also, the staff we do get are paid less, and as such are less likely to really be proud to be making the difference in lives that they are.
“Big deal” you say.
Well, every time I write about staff not changing gloves, or sticking a patient poorly, or doing some other inappropriate thing – someone’s life is honestly and truly on the line. Not changing gloves can EASILY lead to an infection. I don’t know if you know this, but the odds of leaving the hospital healthy after entering with an infection aren’t that great.
Bad sticking affects our accesses. These are quite literally our life lines, and even one bad stick can lead to clotting, and eventual loss of an access. I have been fortunate, but many who infiltrate end up with constant problems resulting in the loss of that access. We only have so many arms and legs, and after that it’s onto catheters – which have a very high infection rate.
See where I’m going with this?
What staff shrug off as a bad stick, or “just forgetting to change gloves” is really incompetence. It can only be addressed through better education, higher standards, and hiring people who understand the importance of their job.
The best way to do that right now, is to allow Medicare to pay dialysis providers what it should for treatment. This brings much needed care to many, like me, who fearfully go to the dialysis clinic, hoping that this treatment isn’t our unlucky treatment.

Please go and make your voice heard

Robin Titterington is a dialysis patient who I know only through the dialysis_support group.
She constantly keeps her head up, and finds something bright and cheery EVERY day of her life.
It amazes me, and I look forward gleefully to reading her posts. She proves to be an encouragement each and every time I read what she has to say.

Today she had quite a time at dialysis, and her post really sort of “struck” me.
After all the talk I’ve been doing today with regards to patient care, it’s difficult for me to read her most recent update and not feel like I would have liked to have been there personally.

OH, today was . . . . something. I have a leg graft, both arms are used up
and the other leg does not have good circulation. I have a tough graft to
stick. I actually learned how to do the arterial myself but after two months
of misses with the venous, decided that was not my thing. I have one tech
and one LPN who can hit it consistently and we have an agreement that if I
don’t complain about waiting, one of them will do it. Or so I thought.

Today one of the newer techs, that I have never personally worked with at
all was setting everything up. As we got closer to “stick” time, I said,
“Monica or Marva will do it, right?” and she said (and I quote) “I want to
try!” I said, “no, I’m sorry, it;s a really hard stick and this is my last
access point. I don’t mind if you try if one of them are here guiding
you.” She totally ignored me. Then she started aiming and I realized she
had the wrong size needle. SIGH So she went and got the right kind.
Again, I said, “I really prefer Marva or Monica do this.” Nope, here she
comes. He just barely got it in, it HURT (I use emla) and I nearly pushed
her away and practically yelled, “YOU ARE DONE. Do not touch me, go get
Monica or Marva. NO, you are NOT going to do this.” She got Monica and I
pointed out to MOnica that I could tell the needle was not in at the right
angle. Monica agreed, we had to take that one out and start over.
Meanwhile, I’m saying (with her still there), “Monica, I told her no but she
ddin’t care what I said. Do people here not comprehend LIFELINE? This is
my last choice and I can’t have people just practicing on me.” Monica is
very easy going and just said, “oh, yeah, no problem.” Then the RN came
over with the heparin (sweet young thing had gone away) and I said “I did
not want to hurt her feelings but it’s a hard stick and my last access.” SHe
just kind of shrugged. Anyway, I guess Monica or Marva talked to th eyoung
one during their break because about an hour and a half later she came over
full of apologies saying she didnt mean to upset me. I said, “I’m not upset
but this is my LAST possible access and I need to protect it.” SIGH, she
just kept apologizing about upsetting me, not sure she really “got it.” She
took me off but we didn’t have much to say to each other. We’ll see what
happens Wednesday. Anyway, I came home and took the fabulous furries out
and we pretended it was a holiday!!! HUGS Robin (getting cheery again)

People deal with adversity in many ways, but you Robin are an encouragement to us all with your rich understanding of life and what matters. You continue to treat those around you with respect and courtesy – even when they have not earned it. You do so I might add, with a smile on your face. We can ALL learn something valuable from this.
You’re today’s awesome dialysis patient (a short list – so consider yourself AWESOME!)
*wink*

Some of you have lived this process with me (the development of my buttonhole sites), and so I feel a need to update everyone that they are still working well.

Extremely well in fact.

It’s gotten to the point that the needles just sort of slide right in, with minimal persuasion from me.
The sites have not gotten any larger, and are very easy to use. If I would have been using them since the beginning I feel my arm would look a lot more “normal” now.

I strongly encourage any of you who are unfamiliar with this to read more about it.
There are very few contraindications – the most prevalent of which is simply the Dr. or clinic’s lack of familiarity with it.
Many doctors and clinics tell their patients that they are not candidates for buttonholes for many reasons, but I fear that frequently this information is incorrect.
Many more patients could be utilizing this technique than are now, and it is the fault of the dialysis industry, and the doctors coupled with them. It’s yet another example of how healthy people who take care of sick people never fully realize how their actions affect the end user.

It’s this sort of rookie stuff that makes me wonder if any of the people working in dialysis think of the patient as a consumer, who demands their utmost attention and care?

There are plenty of industries out there where top notch customer service is not only demanded, but enforced.
The Green Briar – a nice restaurant near here always has people taking care of you who seem to want you to enjoy your stay there.
They seem to take pride in their duties, and in their ability to provide you with a good experience.

Dialysis costs us a heck of a lot more than a good dinner, and is infinitely more important – why then are we seen solely as patients, and not consumers?
If the Facility Administrators would begin to demand this level of service from their employees, we would see some serious benefits I believe.
Techs have to be taught that it is simply unacceptable to do certain things – like have personal conversations with each other right in front of, or while working on, the dialysis customer.
It is unacceptable to treat the customer like they don’t know what they’re talking about, especially as it pertains to their own body.
It should be unacceptable to make stupid sanitary mistakes as well. This sort of thing should result in immediate suspension. If the techs are incapable of figuring these things out on their own, then it is the responsibility of the manager (Facility Administrator) to take care of it. It is unacceptable for techs to work day in and day out with nobody watching their movements and actions with each patient.
This sort of lax behavior results in the high infection rate we have among dialysis patients. I can’t be the only one who is seeing this.
We shouldn’t be seen as complaining patients, we should be seen as customers who demand the full attention, and best care from each tech and nurse. If they don’t want to be in a customer service industry where the customer is put before themselves, then they are in the wrong field completely.
I anxiously await the day that Facility Administrators and those in charge begin to demand what is necessary of their employees.
The customers are waiting – and some are dying while they wait.

Julie is one of the patients coming out of John’s Hopkins who has received a transplant from a donor of an incompatible blood type.

She is also doing very well.

Read her story here.

Blood Type No Longer Matters?

According to this article a “new procedure” helps to remove harmful antibodies pre and post transplant in the recipient. I remember reading something about this being accomplished via plasmapheresis several months ago, but I’m not sure if this is the same thing or not. Unfortunately, the article doesn’t really say.

“There may still be some people whose antibody levels are so high that we can’t overcome them,” he said.

“But for the majority of people who have a donor of the wrong blood group, this will open up a new opportunity.”

The blood filtering treatment was used in the weeks before and after the transplant.

Very interesting, I can’t wait to see how this develops in coming months.
Go Aussies!

In the last year or two a couple of very portable, very usable dialysis machines have hit the market for home patients.
It has been mentioned more than once on the dialysis_support list that there are numerable benefits to home dialysis modalities. Several patients there are utilizing the NxStage machine, and are enjoying the results.

The point of this post isn’t to explain these home modalities, or to get into the specifics of the machines (though I may try to do that in the near future).

The meat is thus:
I started looking at HomeDialysisCentral for information on home modalities, and ended up finding a national coverage map telling me exactly where which of the different home modalities was available.
Perhaps I’m being naive, but I figured such options must not exist here in Colorado, or I would have heard about them. I mean, why would a company such as DaVita who claims to lose money on Medicare dialysis patients, not embrace a modality which would significantly lower their cost of doing business?
I mean, they must not be in favor of such a thing or they would be making me aware of it right?

…

I mean … right?

____________________

So…..
after poking around a bit more I found that Colorado’s home-hemo coverage is provided by DaVita AtHome, the department of DaVita specializing in home modalities.
That’s weird, I would think they’d be trying to recruit me as a home patient. You’d think they’d at least be educating their patients to the options available to them!

How many patients out there are beginning and enduring dialysis treatments in-center simply because they’ve been told to?

I’m constantly encouraging patients to learn as much as they can about their condition and treatment. The reason is to avoid the negatives that come with any chronic illness, typically brought on by over-zealous physicians seeking to better you.
I wrote earlier this week about one such episode. While this particular procedure was recommended, I as the patient had the right to say “no” at any time.

We as patients can not afford to forget this.

After doing some research on the benefits of home dialysis especially for long-term dialysis patients, I’m amazed and appalled that we as patients have to find these modalities for ourselves. Why aren’t our physicians recommending this obviously superior alternative? I understand that perhaps people would still choose in-center dialysis due to comfort-level (I have been doing in-center for nearly 4 years now). Why though, are these people not even being made aware of these simple, superior home modalities such as the daily home-hemo done with the NxStage machine?

This is not a rhetorical question – I’d love to hear the reasoning behind it.

As I sit here listening to Young MC’s Roll With The Punches – I wonder how it is that a DaVita patient who has been proactive, interested, and prone to self care has not been made aware that DaVita itself offers some very new home-dialysis options?(!)

My guess is that it has something to do with the doctors themselves, and their relationship with the dialysis providers. The only thing that would change with me moving to home care (assuming it was the best option) would be the physician in charge of me. The provider (and recipient of my Medicare $$) would still be DaVita.

I can’t be so cynical – it can’t be so… There has to be another obvious solution that I am foolishly blind to at the moment.

Someone please fill me in.

No, this is not when a large blood-vessel shows up at your doorstep to deliver some candy and a friendly message from a friend.
Instead, it is a procedure in which your fistula is “checked out” from the inside.

Why Do One?

Normally this test is done to see if there are any problems inside the fistula, affecting its flow. For example, perhaps there is a stenosis (narrowing) of the vessel constricting the flow. Normally this happens further up the arm, as the blood is on its way back to the heart.

So What Do They Do?

Don’t let them fool you, it’s a surgical procedure.
Not very painful, but because of the surgical surroundings, it is a tad uncomfortable. You change into the hospital gown, sign the papers (the normal ‘I/my family will not sue you if I die right now’) and head into the room. In front of you is a large table with all sorts of goodies spread out on it.
I kept thinking to myself “wait, they said this was just going to be some X-Rays of my arm with die in it!” It was – it’s just that they like to freak you out a bit with tools, assistants, blue-paper wrapping everything, and oxygen pumped into your nose. “Why are they trying to calm me down with O2″ I thought to myself. “Is this going to be more invasive than I thought?”

Well, yes, and no. It was a surgical procedure, but I would have no problem doing it again (if I absolutely had to).
The reason they set it up this way is so that they can take care of any problems they may run into right then and there (narrowing, clotting, etc.).

So basically they thread a catheter into the fistula. The needle used isn’t any bigger than what’s used during dialysis procedure – so no real discomfort there. This catheter then dispenses iodine into the vessel, which is then bombarded with x-rays. I don’t know what sort of FPS this machine was capable of, but it seemed like it was probably taking at least 5 pictures a second. So you’re sort of watching x-ray video of the inside of your arm – followed by a rush of dark liquid which you see flow through your vessels, and through the fistula.

Awesome!

Well, yeah, but it would’ve been much more intriguing if I were watching someone else’s fistulagram take place. As it was there were a lot of Our Father’s going on.

What Did They Find?

Awww – the meat of this post.

My basic beef with much of the medical community for the last nine years has been their lack of sensitivity regarding almost everything they do. Doctors have become so preoccupied with quantity of life, that they have forgotten that their goal is quality of life. So it’s not uncommon to have an entire team of physicians chasing something in you that doesn’t exist – or is posing no real problem.

This test was ordered because my KT/V value was a bit low, and my potassium was a bit high. Both out of the acceptable range, but not by a large margin. Rather than re-draw the tests, an invasive procedure seemed the logical answer. When I questioned this the answer was essentially “well, you’ve never had a fistulagram.” As in, it almost felt like “why not?”
Yes, it was explained to me that low KT/V and high potassium were definite indications of lowered blood flow through the fistula – but rather than re-draw these two simple tests, it was decided that there was no reason not to do one.

The best was being told beforehand that they didn’t think they would find anything wrong. Was that said solely to comfort me? Why the lies? Obviously you think there’s something wrong or why am I going through this in the first place?

For the most part the test went alright, until they decided to take a look at the arterial side of the fistula. The Dr. inserted a new catheter in a new site going in the opposite direction towards the arterial anastomosis. Explaining what buttonhole technique was and why they should avoid these two particular sites was hilarious.
Nurse to surgical assistant after I requested that I be able to show the Dr. where to stick:

“He needs to show the Dr. his buttons, they’re a great access.”

*me rolling eyes*

“Uh – no … ‘buttonhole technique’ is the method I use to cannulate, it’s also called constant-site tech…. you know what? never mind – the point is, he needs to be at least one inch AWAY from these sites either proximally or distally, they are NOT accesses for him to use!”

So with the new catheter threaded in and going towards my wrist, they tried to create some back flow into the artery by partially occluding the fistula and squirting in some iodine. The thinking was that without the blood pulsing through the fistula, it would back flow into the artery, at which point they would see it entering the fistula, and check for blockage.
It didn’t work.
For the next hour, they tried over and over to occlude the fistula and squirt in more iodine. For some reason they couldn’t see the radial artery, or my arterial anastomosis (point of connection between the vein and artery).

After a bit of confusion as to how my fistula must have been created, they spoke with the surgeon who created it. His first question to me: “Why are you here?”
“Good question” was my reply.

So after a couple hours of poking and prodding, two very educated doctors decided that there was really nothing to be seen on this day. Both seemed to think – “Leave well enough alone”.

The trick will be convincing my doctors that this is the best course of action. I can practically hearing them now telling me why I need an arteriogram to assure them that there’s no problem with my fistula’s in-flow.
For those non-medical types, the arteriogram is much like my fistula gram, only they feed the die in from the arterial side. Meaning that they must thread a catheter from my femoral artery (in the groin) aaaaaalll the way to my arm.

Needless to say I’m not going to be advocating for that particular test – nor will I be doing it unless there is some other evidence that it is needed.
I understand the need to catch things before they get out of hand. But are we perhaps being a bit over sensitive here?
Every time my KT/V has been lower they have wanted to do a fistulagram. For four years, I have said “No. Re-draw the lab.” And every time, the new KT/V value has been better.

Why would you use this one test if it varies so much? And why does it vary so much?
For one, time is factored into it – time dialyzed. So having a picky machine alarm all night greatly affects the accuracy of the KT/V. Or how long the tube sits in the back of the nurses station before being spun down. There are tons of factors – all of which can affect the accuracy of KT/V. Why then would you rely solely on this value?
“But your potassium was also high.”

Great, potassium – another test that’s very picky. Perhaps my potassium was high due to the extra helping of potato salad I had the night before you drew that lab? Potassium can build up VERY quickly in the blood stream, so having a slightly higher than normal potassium reading could be due to just having eaten something containing some potassium.

I should make it clear that there may indeed be a problem. I might be writing in two weeks time about my arteriogram, how painless it was, and how thankful I am we caught this so quickly.
I’m not always right (pretty much always though).
If these tests and procedures are really indicated, I have no problem going through with it.
I just can’t help but feel used on this one though. I felt it wasn’t necessary in the beginning, and now after a very uncomfortable day for my wife and I, we have no more information than we did before, and two doctors asking us why we even came in.

Forgive me if this is more venting than educational – I hope this information can help someone to ask “do I really need to do this-or-that test?”
As patients we have the right to do (or not do) whatever we feel is necessary. It is very important for you to fully understand what you’re going through, and not just follow along blindly.
Otherwise, at the end of it all you look back and realize there were many things you went through that you did not need to.
I know.