On 9/6/07 You may be able to give feedback to FDA on Anemia Treatment

[Black]

FDA to Hold Hearing that Could Affect Your Anemia Treatment 
On September 11th, the Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting to update information related to the risk and benefits of ESA for treatment of anemia for end stage renal disease patients (ESRD). 

The outcomes from this hearing could drastically change the manor in which your physician is allowed to treat your anemia. 

It is critical that the FDA hear from kidney patients on the impact that ESA’s have had on their quality of life.  If you are a kidney patient, please let DPC know how anemia management affects your quality of life. 

Are fatigued when your hemoglobin falls? 
Have you ever been so anemic that you needed a blood transfusion?   
How do you feel when your hemoglobin is raised and lowered? 
Let your voice be heard!  Email DPC by September 6th and we will share these stories with individuals who are testifying before the FDA Panel.
 [The clickable email link can be found here - note the two line address - may need to copy and paste]
http://advocacy.dialysispatients.org/site/PageServer?pagename=enews_fda_9407&JServSessionIdr007=tj6tasv2m1.app14a

[stauffenberg]

In Germany, the basic legal principle regulating the medical profession is called 'freedom of treatment' (Behandlungsfreiheit), which states that ANY treatment agreed to by a doctor and his or her patient is permitted.  In contrast to the United States, where a whole gamut of public institutions, professional society rules, and government regulations are permitted to disrupt the freedom of treatment, Germany enshrines this freedom for both patients and doctors, which I think is as much an essential human right as any of those codified in the Bill of Rights.

With respect to these new EPO regulations being considered in the U.S., I smell politics in the background, since the right-wing forces in the U.S. government hate to have to fund dialysis at all, and so squirm to find every opportunity to reduce the cost of this socialist program, including finding excuses to cut down on the amount of EPO administered, which is quite expensive.

After the first year of federal funding of dialysis in the early 1970s, right-wing Congressmen tried to cancel the Medicare payment for dialysis entirely, saying that the costs were much greater than anticipated.  This would have amounted to genocide of a huge number of patients with no other way to fund their dialysis treatment, but hey, think of how much the progressive tax rate, so painful to rich folk, could have been reduced!  Now the same government philosophy remains in place, though for the moment it can only summon enough power to threaten adequate EPO funding.

[BigSteve]

I agree again with Stauffenberg in his statements on politics in the U.S.
However I don't know if they apply in this case. Although I can not
find the updated hearing information of the FDA website the FDA
Public Health Advisory is the background of this hearing.  Here's a couple
quotes from the Advisory dated March 14, 2007.
    "A higher chance of death was reported and an increased number
of blood clots, strokes, heart failure, and heart attacks was reported in
patients with chronic kidney failure when ESAs were given to maintain
hemoglobin levels of more than 12 g/dL."
If the hearing is about the overuse of ESAs (Aranesp, Procrit, Epogen) then
possibly there is some merit. Also there is a huge political battle going on
over this issue. Amgen Corp. the maker of the drug is fiercely lobbying
members of Congress to petition the FDA. The link in Black's post is
sponsored by DaVita, a firm which is frantically pushing its patients and
employees to send letters to local Congress members. So how much
is DaVita making on each dose?

[stauffenberg]

I fully agree with BigSteve that there are two monsters in the ring on this issue: the drug companies pushing the patients to use more EPO, safely or not, just to raise company profits, and the government acting as the agents of the wealthy, trying to keep taxes low and thus working to lower EPO doses, regardless of how the patients' lives will be reduced in quality.  The use of EPO is, like most choices in medicine, a balance of risks and benefits, and I want each doctor and patient to be able to decide for themselves without interference how to draw that balance in the patient's best interests.  Some people are willing to run a greater risk of stroke for the sake of a higher quality of life with the greater energy EPO will give them, while others would prefer to extend even a low-quality, vegetative existence with severe anemia, just as long as they can have greater security of living longer.  The important point is that the gamble should be up to the patient, not a Washington bureaucrat who cares only about lowering taxes so that the rich folk who fund the political campaign costs get what they paid for.

[Zach]

... while others would prefer to extend even a low-quality, vegetative existence with severe anemia, just as long as they can have greater security of living longer ...

This comment is just a load of crap!  Unfortunately, the more you repeat this garbage, the more likely people may start believing it.

There's not question that EPO has increased quality of life.

But thousands of people on dialysis lived good-quality lives long before EPO ever existed.  Keeping one's hemoglobin at 12 gm/dl will not cause them to have a low-quality, vegetative existence.

You do more harm than good with these type of pronouncements stauffenberg.
 

[BigSteve]

FDA advisory panel
    "A higher chance of death was reported and an increased number
of blood clots, strokes, heart failure, and heart attacks was reported in
patients with chronic kidney failure when ESAs were given to maintain
hemoglobin levels of more than 12 g/dL."
Zach: I don't know if you are interpreting Stauffenberg points adequately.
His main point, and it's one I have been thinking about, is the right of
any patient to choose his therapy as recommended by his physician without
interference from the outside, whether HMOs or the Federal Govt.
My only concern is whether the patient in many cases will be given
the full and adequate information necessary for informed consent.
I have seen too many physicians in the last 10 years who are
extremely reluctant to give information unless prodded.

[Zach]

I'm only addressing his "either or" statement.

[stauffenberg]

Since normal hemoglobin for healthy males varies between 140 and 170, for some males a hemoglobin of 120 will be 50 points below what their genetic make-up has designed them to function with, while for others it may be onlly 20 points below what they are designed to function with.  Perhaps you can run a motor-scooter on low octane fuel, but don't try to use that in a truck!

Humans have evolved over three million years, during which time the body has developed to maximize the efficient use of energy.  It costs a human to obtain and metabolize energy, so every bit of energy expended in producing the chemicals, hormones, and structures which allow the body to function is minimized by selective pressures in evolution.  So when the body normally sets the hemoglobin level of the average male at 140, these extra 20 points above 120 are there for a good reason.  Keep in mind it is not just the subjective sense of energy and strength which is being maintained by hemoglobin, but also the oxygenation of the tissues of the body, which is diminished by hemoglobin levels below normal.  This is why nephrologists try to increase hemoglobin levels in dialysis patients who have had heart attacks, for example, to promote the oxygenation and thus the repair of the heart muscle.

Some people will feel utterly exhausted at 120, as I did, and others will not, but my hemoglobin prior to renal failure was always in the 160s.  But as we know, if nephrologists are told not to go above 120, they will often err on the low side, and almost everyone will feel tired at 100-110, where they will wind up given the difficulties of managing not to touch the 120 barrier with all the complex dosing variables of EPO.  Further, how do we know exactly what is being contemplated by these FDA reconsiderations of the permitted use of EPO in nephrology?  What if they come to the conclusion that the risk/benefit is most sensibly set at 110?