I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on July 23, 2011, 02:05:03 AM
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Safety of Epogen dosages questioned
By Tom Kisken
Posted July 22, 2011 at 9:09 p.m.
Ventura County's largest private employer built its empire on a miracle: a drug that reduced the need for blood transfusions among legions of American dialysis patients and their suffering counterparts worldwide.
The astounding product, Epogen, even countered the anesthetizing fatigue that accompanies each dialysis session, Amgen of Thousand Oaks pronounced for 18 years after the drug's 1989 debut.
"We focus on science that uncovers new ways of understanding biology, makes significant contributions to medical knowledge, and can be applied to new approaches to treating disease," Amgen spokeswoman Christine Regan said in an email outlining company philosophy.
"Amgen's mission is to serve patients," she said.
But after more than two decades of widespread use and $60 billion in Medicare payments for the drugs, new regulatory guidelines have questioned the safety of Epogen dosages and dosages for Amgen-developed descendants of the product.
Health experts are coupling that development with Amgen's political lobbying against a proposal to provide kidney transplant patients a lifetime of the drugs needed to keep them off dialysis. They are sharply critical of the company.
"Over the years, Amgen has given us ample evidence that they're a very strategic, profit-motivated Corp. with questionable regard for patients' health or safety," said Rep. Pete Stark, D-Fremont, who has called for restrictions on Epogen use as a ranking member on the House Ways and Means health subcommittee.
Regan acknowledged that Amgen joined the rest of the dialysis industry in successfully opposing the kidney medication proposal by Sen. Dick Durbin, D-Ill., which was extracted last winter from the health reform law. Durbin has pledged to reintroduce the measure before year's end.
Though the Congressional Budget Office estimated it would cost a relatively modest $100 million a year to fund the kidney medications, Regan argued the money could not be spared from Medicare's $8.6 billion annual dialysis budget. Amgen receives at least $2 billion a year from that Medicare coffer for providing Epogen and its other drugs.
"The important goal of expanding access to immunosuppressive drugs for transplant patients should not be tied to policies that will restrict access to other products of critical importance for dialysis patients," Regan said.
Lori Hartwell, a four-time kidney transplant patient who started the Glendale-based Renal Support Network, put it more simply: "We didn't feel it was fair to take away from one group to help another group. We wanted a different solution."
Hartwell's nonprofit organization for patients is part of a national lobbying group that includes Amgen and the country's largest dialysis providers.
The director of the kidney transplant program at Cedars-Sinai Medical Center in Los Angeles, Dr. Stanley Jordan, said he's disappointed Amgen opposed legislation providing the lifetime benefits. The company has been at the forefront of kidney disease awareness, he said.
"I don't see their argument," the doctor said. "I don't think there's a sustainable position."
Today, nearly all U.S. dialysis patients, as well as some cancer and HIV patients, are prescribed the Amgen drugs.
But with its home run drug, Amgen was forced to backtrack on a powerful initial claim.
The company's long-standing citation of studies asserting Epogen fought fatigue was scrutinized by the U.S. Food and Drug Administration, which instructed Amgen and other drugmakers to reconsider such claims in 2007. Amgen now says on official company disclaimers for the drug that "Epogen has not been proven to improve quality of life, fatigue or well-being."
Amgen's assertion that the drug helped dialysis patients recover from the unrelenting fatigue that relegates many of them to part-time lives was based upon studies that posed open-ended survey questions to patients, said Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit that evaluates the clinical and economic implications of health technologies.
By 2009, his studies showed strong evidence the drug increased risk for stroke, heart attack and death. His most recent findings, published last month, show a 28 percent increase in the risk of death for diabetic patients receiving higher dosages of the drug.
"What we do know, what we demonstrated, is that with high doses of Epogen the risk went up tremendously," said Cotter.
After years of issuing more-stringent warning labels, the FDA finally announced on June 24 new guidelines that are projected to slash the U.S. clinical use of Epogen by as much as a third. The FDA cited the increased risk of cardiovascular events ranging from stroke to death.
Amgen-developed offshoots of the drug called Aranesp and the Johnson & Johnson product Procrit, which is manufactured by Amgen under contract, are projected to see similar reductions in use.
The company issued a news release that coincided with the FDA announcement on June 24, saying it supported the new guidelines.
Years of regulatory scrutiny of showcase products might have been enough to cripple other companies. But by the time the benefits of Epogen were challenged by researchers and regulators, Amgen had become the world's largest biotechnology company with enviable political influence.
According to the Washington, D.C.-based Center for Responsive Politics, Amgen spent $10.2 million on federal political lobbying in the most recent full year of 2010. That is second only to drug giant Pfizer, which spent $13.3 million on lobbying.
Amgen also raised its charitable profile with its Safety Net Foundation program, which Regan said is providing free Amgen drugs to 7,600 patients currently enrolled.
Dr. Kant Tucker, who operates Simi Valley-based Kidney Center's eight dialysis sites in Southern California, said Epogen's undisputed ability to reduce the need for blood transfusions can't be overemphasized.
However, he wishes the drug was less expensive. It accounts for an estimated one-fifth of all Medicare dialysis expenditures.
"One starts to wonder when the price will start to come down," he said.
That could happen because Amgen's patents on Epogen products will begin to expire over the next few years, allowing the production of generics.
Cotter said his organization will continue to measure the safety of Epogen-type products, no matter who makes them.
But criticism of Epogen can be a hard sell to very ill dialysis patients who for years have taken the drug under the belief it helps with dialysis fatigue in addition to reducing the need for transfusions.Ron Taubman, a Santa Clarita resident who was on dialysis before receiving a kidney transplant last year, said he has no doubt that Epogen helped him recover from grueling dialysis sessions.
"I would sit and shiver. I was cold all the time. I would be getting aches and pains," said Taubman, who leads a Ventura and West San Fernando Valley support group of transplant recipients.
"It was a slow process, but I felt a whole lot better."
The reason Taubman felt better, Cotter said, also is what makes the drug dangerous. When Epogen increases red blood cell counts, it also increases blood viscosity, to the point that it has trouble passing through the circulatory system. That creates high blood pressure and a host of other problems among kidney patients, who are already often diabetic.
"There is much more work for the heart to do to pump blood," said Cotter. "That becomes the rub."
Read more: http://www.vcstar.com/news/2011/jul/22/Kidney_Transplantamgen/#ixzz1SuwlOhAX
- vcstar.com
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That drug has made Amgen a WHOLE lot of money. $$$$
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im wondering ... what is considered "large doses"
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im wondering ... what is considered "large doses"
Me too, boswife. My brother is diabetic and one of his recent hospitalizations was due to a circulation issue. I guess it's time to learn a little more about Epogen and to start paying attention to the dosage/frequency of administration as well as the anemia numbers.
...Amgen joined the rest of the dialysis industry in successfully opposing the kidney medication proposal by Sen. Dick Durbin, D-Ill., which was extracted last winter from the health reform law. Durbin has pledged to reintroduce the measure before year's end.
Though the Congressional Budget Office estimated it would cost a relatively modest $100 million a year to fund the kidney medications, Regan argued the money could not be spared from Medicare's $8.6 billion annual dialysis budget. Amgen receives at least $2 billion a year from that Medicare coffer for providing Epogen and its other drugs.
So, those who make a lot of money off of ESRD victims on dialysis are opposed to funding immunosupressants for the life of a transplant? Do they want to bring them back to dialysis to keep their gravy train rolling? Disgusting (or am I too cynical?)
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When Epogen increases red blood cell counts, it also increases blood viscosity, to the point that it has trouble passing through the circulatory system. That creates high blood pressure and a host of other problems among kidney patients, who are already often diabetic.
"There is much more work for the heart to do to pump blood," said Cotter. "That becomes the rub."
What does this mean exactly? Epogen increases red blood cell count which in turn increase blood viscosity. Does it increase blood viscosity to a greater extent than receiving a transfusion to the same blood count? Or does a transfusion cause a similar increase in blood viscosity and blood pressure?
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I don't know for sure, but if you take epo on a regular basis (which most dialysis patients do), perhaps that is what causes the blood to become more viscous. I'm supposing that it is the frequency of epo that causes this problem.
What can be done to reduce the need for epo in the first place? If more patients got more dialysis instead of MWF, etc, would that decrease the need for this drug?
It's rather disgraceful that this company is spending so much money on lobbying. Boswife, I think "large doses" means doses large enough to get your hemoglobin to up around 12.
This is part of the frustration of ESRD; corporations just see us as bags of money. And aharris, no, you're not too cynical.
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Ive been on Epo for four months now and have been researching the dangers associated with it. From what I understand the most danger comes from centers not properly monitoring hemoglobin levels and allowing them to rise above 12. I just found out that my center's goals is for a hemoglobin count of between 10 - 12 and since I administer my own shots I plan on staying on the low side of that range.
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Ive been on Epo for four months now and have been researching the dangers associated with it. From what I understand the most danger comes from centers not properly monitoring hemoglobin levels and allowing them to rise above 12. I just found out that my center's goals is for a hemoglobin count of between 10 - 12 and since I administer my own shots I plan on staying on the low side of that range.
Yeah, that's what I'd do, too.
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I was thinking about the viscosity of blood today re epogen, and I am wondering if the dialysis process itself is at the root of the problem. There are three places where fluid resides...in your cells, between your cells and in your blood. Dialysis removes fluid only from your blood. So, if there is less fluid in your blood AND more red blood cells in your blood as a result of epo, that seems to me would make the blood more viscous at least for a time right after a treatment, and this may explain why hemoglobin levels are supposed to be kept lower in dialysis patients than in the general population. Now, I've just sort of made this up; I haven't read anywhere the biomechanics of all this, but this is what I was pondering while I was swimming; my brain never shuts off, unfortunately.
Does this make sense? Is this even approaching correct?
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Well J is to start low dose of Epo today. His Hgb has been really great! Generally 10 to 10.5. He hasnt taken Epo since late Nov of last year! Now last week his iron was low so they gave him IV iron. This is probably why he is back on Epo. I too, give the shots and watch for stickiness to his blood! It is all a fine balancing act in my opinion. You tilt to far to the left or right, then you have to fine tune to bring it back center! It can be a head ache at times, but it is one I welcome! I try not to stress myself over it too much!
lmunchkin :flower;
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My HGB was in the 7s/8s for years and I was chronically fatigued pre-D. No insurance and couldn't afford EPO. Despite that I exercised a lot and played a competitive sport 3 days a week and managed. Now on PD finally and medicare I finally start getting EPO treatments and IV iron and WOW I felt stronger than I had in years and ready to take on the world!
But no, my HGB was 13-something and that's bad, bad, bad...wouldn't want someone to actually feel GOOD. The protocols must be followed! So stop the EPO and get my HGB below 12...yeah, now after two weeks I'm stating to feel like crap again. Surely they can push the upper edge of the protocol for someone like me who is trying to be more active than perhaps is usual for the general dialysis population?
:banghead;
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Surely they can push the upper edge of the protocol for someone like me who is trying to be more active than perhaps is usual for the general dialysis population?
:banghead;
The only problem is, when they use epo to get Hgb levels above 12, people start dying. Do you think because of your physical activity level you are immune to this. Maybe you are, I don't know. I haven't seen any data to support that conclusion though. Are you wiling to take that chance?
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Surely they can push the upper edge of the protocol for someone like me who is trying to be more active than perhaps is usual for the general dialysis population?
:banghead;
The only problem is, when they use epo to get Hgb levels above 12, people start dying. Do you think because of your physical activity level you are immune to this. Maybe you are, I don't know. I haven't seen any data to support that conclusion though. Are you wiling to take that chance?
Well, even my own lab sheet shows the normal Hgb range to be something like 13-16 and a quick Google search shows the acceptable range for adult males to be anywhere from 12.5 to 18.5 depending on the source. So is there a dialysis related reason as to why we are restricted to an Hgb <12? I'm no fool and understand that more is not always better and that a level of Hgb that is too high can have its own set of bad side effects. But I get the feeling that the range 10-12 was picked by some bureaucratic committee as "close enough for government work" so Medicare and/or insurance companies don't have to shell out for the EPO drug.
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I posed this query to Dr. Agar on his Home Dialysis Central site (in case you don't know, he is an Australian nephrologist who speaks all over the world on dialysis and is an untiring advocate of more frequent, optimal dialysis), and you can see his reply here...
http://forums.homedialysis.org/showthread.php/2941-Hemoglobin-levels-in-dialysis-patients?p=21288#post21288
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I totally agree with this article, MM. I found this out not by the make up of the insides of someones body, but by the visual observations of my husbands health. The longer his blood gets cleaned, which working kidneys do without rest, the more you get to a feel better patient without the side effects. Now he still has a few side effects, but not as much as he use to, and he doesnt require alot of meds that he was taking. All due to and extra 1/2 to 1 hour on D. I do not understand why more people are not doing this at home where they can make a difference in the lives of ESRD patients. Maybe, Im sure, they have there reason! But for us, it is a no brainer!
Excellent read Moosemom! Thank you!
lmunchkin :flower;
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he doesnt require alot of meds that he was taking. All due to and extra 1/2 to 1 hour on D. lmunchkin :flower;
And thank you Lmunchkin for pointing this out! I know it was a long time ago (2000), but I still can remember fighting with my daughter when I tried to get her to spend more time on the machine. I got told I "didn't know what it was like to be on dialysis" and to butt out. I do remember the lounge chairs seemed rock-hard and I was dealing with an impatient 18 year-old.
However, I talked alot to Dr. Bays - a founder of DialysisEthics - who was on dialysis and knew even then that longer and slower dialysis was better. But I wasn't getting through and was further told told to give up my kidney and to then get out of her life. Fortunately, she changed her mind about me getting out of her life and I resisted the urge to hog-tie her to the machine. She looked like he** until the transplant, got the transplant, perked right up, and we have found other things to fight about (my eating habits being one thing).