Medical Drug Policy Anemia
July 21, 2012 1:29 PM Subscribe
Anemia drugs made billions, but with what benefit and at what cost? 'For years, a trio of anemia drugs known as Epogen, Procrit and Aranesp ranked among the best-selling prescription drugs in the United States, generating more than $8 billion a year for two companies, Amgen and Johnson & Johnson. Even compared with other pharmaceutical successes, they were superstars. For several years, Epogen ranked as the single costliest medicine under Medicare: U.S. taxpayers put up as much as $3 billion a year for the drugs.'
'The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug — including “life satisfaction and happiness” according to the FDA-approved label — were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked.
Last year, Medicare researchers issued an 84-page study declaring that among most kidney patients, the original and largest market for the drugs, there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” besides elevating a statistic for red blood cell count.
It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.
How did this happen?'
'The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug — including “life satisfaction and happiness” according to the FDA-approved label — were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked.
Last year, Medicare researchers issued an 84-page study declaring that among most kidney patients, the original and largest market for the drugs, there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” besides elevating a statistic for red blood cell count.
It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.
How did this happen?'
Surely cyclists in the '80's and '90's benefited from them, well at least the ones that didn't die.
posted by Grumpy old geek at 1:50 PM on July 21, 2012 [3 favorites]
posted by Grumpy old geek at 1:50 PM on July 21, 2012 [3 favorites]
Small potatoes compared to what's coming.
posted by telstar at 1:52 PM on July 21, 2012 [1 favorite]
posted by telstar at 1:52 PM on July 21, 2012 [1 favorite]
Just to be clear: improving one's red blood cell count does not translate to any clinical benefit?
posted by Yakuman at 1:58 PM on July 21, 2012
posted by Yakuman at 1:58 PM on July 21, 2012
Just to be clear: improving one's red blood cell count does not translate to any clinical benefit?
Just to be clear: You did read the linked article before posting that question?
Page three of the linked article.
For a narrow portion of those patients — dialysis patients with anemia so severe they needed occasional blood transfusions — the drugs, if used in limited amounts, did offer a critical benefit, one that doctors say amounted to a revolution in treatment. Patients with severe anemia said it could restore their vitality. The new drugs allowed them to avoid the risks of transfusions, which can carry diseases and raise future complications for transplant patients.
The rest of the article discusses how drug companies began making claims regarding the drug that had to be withdrawn 13 years later.
posted by kisch mokusch at 2:10 PM on July 21, 2012 [1 favorite]
Just to be clear: You did read the linked article before posting that question?
Page three of the linked article.
For a narrow portion of those patients — dialysis patients with anemia so severe they needed occasional blood transfusions — the drugs, if used in limited amounts, did offer a critical benefit, one that doctors say amounted to a revolution in treatment. Patients with severe anemia said it could restore their vitality. The new drugs allowed them to avoid the risks of transfusions, which can carry diseases and raise future complications for transplant patients.
The rest of the article discusses how drug companies began making claims regarding the drug that had to be withdrawn 13 years later.
posted by kisch mokusch at 2:10 PM on July 21, 2012 [1 favorite]
Paywall after the second page and the article seems determined to make the point that drug companies are bad and doctors are gullible. And they conflate gross margin with net margin. And seem to be using today's dosing standards to judge yesterday's dosages. Seems kind of like a hack job, especially without other links to compare...
posted by gjc at 2:14 PM on July 21, 2012
posted by gjc at 2:14 PM on July 21, 2012
How did this happen? is a silly question. 22 x 8 = $176B reasons why it happened. Do you really think even $1B was spent developing and producing this drug? If the profit for a useless drug which endangered people's lives was "only" $1B instead, would that be OK?
Is there a "corporations being criticized, oh noes" flag that goes up?
posted by maxwelton at 2:34 PM on July 21, 2012
Is there a "corporations being criticized, oh noes" flag that goes up?
posted by maxwelton at 2:34 PM on July 21, 2012
For those hitting a paywall: if you're on Safari, turn on Private Browsing - and go to the print option right under the photo in the article, you'll get the text, though no photo.
posted by VikingSword at 2:38 PM on July 21, 2012 [2 favorites]
posted by VikingSword at 2:38 PM on July 21, 2012 [2 favorites]
Unlike drugs that a patient picks up at the drugstore, drugs administered by a physician, as these were, can yield a profit for doctors if there is a “spread” — a difference between the price they pay for the drug and the price they charge patients.Doctors now talk about their "spread" on administering drugs to patients. God fucking damnit, America
In this case, drugmakers worked diligently to make sure that doctors had an incentive to give large doses — that the spread was large. They offered discounts to practices that dispensed the drug in big volumes. They overfilled vials, adding as much as 25 percent extra, allowing doctors to further widen profit margins. Most critical, however, was the company’s lobbying pressure, under which Congress and Medicare bureaucrats forged a system in which doctors and hospitals would be reimbursed more for the drug than they were paying for it.
The markup that doctors, clinics and hospitals received on the drugs given to Medicare patients reached as high as 30 percent, according to the Medicare Payment Advisory Commission, a group that advises Congress. And the markup on doses given to patients covered by private insurance was even larger.
And of course ...
The discovery, which grew out of research funded in part by the National Institutes of Health...We pay for the scientific research, the drug companies pay for productization, sales and marketing, and then we pay for our now patented ideas to be sold back to us. Colonial capitalism
posted by crayz at 2:54 PM on July 21, 2012 [5 favorites]
Seems kind of like a hack job, especially without other links to compare...
Here you go:
Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease
Medicare's Blood Drugs
FDA Drug Safety Communication
Please enlighten us all about how using such sources as the New England Journal of Medicine and the FDA amounts to a "hack job".
posted by kisch mokusch at 2:59 PM on July 21, 2012 [1 favorite]
Here you go:
Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease
Medicare's Blood Drugs
FDA Drug Safety Communication
Please enlighten us all about how using such sources as the New England Journal of Medicine and the FDA amounts to a "hack job".
posted by kisch mokusch at 2:59 PM on July 21, 2012 [1 favorite]
This is not a hack job; it's a case study in how every single molecule of American society has been corrupted by money and power
Amgen, the FDA, the research study authors, the doctors getting free lunches and "spread", the National Kidney Foundation in the tank for Big Pharma, the Republican and Democratic politicians all in the tank, the dialysis clinics...
posted by crayz at 3:15 PM on July 21, 2012 [7 favorites]
Amgen, the FDA, the research study authors, the doctors getting free lunches and "spread", the National Kidney Foundation in the tank for Big Pharma, the Republican and Democratic politicians all in the tank, the dialysis clinics...
Analysts at the time asked chief executive Kevin Sharer why there had not been a prompt disclosure.This went on for 25 years. The executives at Amgen and Johnson & Johnson should be put in prison for the rest of their lives and buried in unmarked graves; Amgen should be given the corporate death penalty; the entire country should be ashamed of itself
"Perfection says we should have done that"
posted by crayz at 3:15 PM on July 21, 2012 [7 favorites]
This kind of margin spread happens with many of the more exotic anticancer therapeutics as well. I was at one talk where it was explained in gory detail the literally several orders of magnitude difference in potential income for prescribers selecting monoclonal anti-melanoma meds versus something much cheaper and offering long-term survival benefits for some such as IL-2.
posted by meehawl at 3:34 PM on July 21, 2012 [3 favorites]
posted by meehawl at 3:34 PM on July 21, 2012 [3 favorites]
My beloved cat Echoes died yesterday from chronic kidney failure; she was on Epogen, the very same bottle humans get, for the last few months of her life. For her, at least, it was a miracle drug with regards to "life satisfaction and happiness" -- she'd go from crouching in her hiding place to seeking food and affection. Her anemia was severe, though, and I wasn't injecting her with too much Epogen, nor was I doing it to turn a profit... and when it was time for her to die she did so quietly, in peace, among friends.
One of the things which has shocked me the most about caring for her is how much better and more affordable veterinary care is than the care I get, top-notch insurance notwithstanding. Something is topsy-turvy in America.
posted by vorfeed at 3:50 PM on July 21, 2012 [5 favorites]
One of the things which has shocked me the most about caring for her is how much better and more affordable veterinary care is than the care I get, top-notch insurance notwithstanding. Something is topsy-turvy in America.
posted by vorfeed at 3:50 PM on July 21, 2012 [5 favorites]
I'm sorry for your loss, vorfeed. She's a beauty.
posted by something something at 4:29 PM on July 21, 2012 [1 favorite]
posted by something something at 4:29 PM on July 21, 2012 [1 favorite]
"Neither Amgen nor the FDA would release a copy of the study report."Are you f*cking kidding me?
posted by smidgen at 9:41 PM on July 21, 2012
Please enlighten us all about how using such sources as the New England Journal of Medicine and the FDA amounts to a "hack job".
I dunno. it does read a bit like a hack job. The links you provide don't refute the "using today's dosing standards to judge yesterday's dosages" idea that gjc put. Basically, these are expensive drugs with that, over the years, changed in usage due to real life observation on their efficacy. Furthermore, the idea that they didn't "have “clinical benefit” besides elevating a statistic for red blood cell count" sounds kind of odd, especially if your count is dangerously low. In which case, they have very real benefit, and remain used to this day in such cases.
posted by 2N2222 at 1:01 AM on July 22, 2012
I dunno. it does read a bit like a hack job. The links you provide don't refute the "using today's dosing standards to judge yesterday's dosages" idea that gjc put. Basically, these are expensive drugs with that, over the years, changed in usage due to real life observation on their efficacy. Furthermore, the idea that they didn't "have “clinical benefit” besides elevating a statistic for red blood cell count" sounds kind of odd, especially if your count is dangerously low. In which case, they have very real benefit, and remain used to this day in such cases.
posted by 2N2222 at 1:01 AM on July 22, 2012
The links you provide don't refute the "using today's dosing standards to judge yesterday's dosages" idea that gjc put
No, because the "idea" is nonsensical. The article doesn't compare A to B, it explains how the the usage of these drugs expanded, the role that financial incentives had in that process and the subsequent research that refuted the recommendations of Amgen and Johnson & Johnson.
Furthermore, the idea that they didn't "have “clinical benefit” besides elevating a statistic for red blood cell count" sounds kind of odd, especially if your count is dangerously low.
I honestly don't see how you could read the article and write that sentence. The commentary on the overstated clinical benefit made in the article does not refer to patients with severe anemia. Rather, it refers to the concept that "more is better" that was being promoted at the time by the drug manufacturers. And when Amgen funded a trial to explore this concept, it halted the trial because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-hematocrit group. But when they published the results, they wrote that the rate of death was not statistically higher in the higher-dose group. In other words, they terminated a clinical trial before the numbers that demonstrated specifically how it should not be used reached statistical significance. Which is actually a good thing for the safety of the patients in the trial, but to then continue recommend using higher dosages because there isn't any evidence that it's dangerous is pretty abhorrent.
posted by kisch mokusch at 2:16 AM on July 22, 2012 [3 favorites]
No, because the "idea" is nonsensical. The article doesn't compare A to B, it explains how the the usage of these drugs expanded, the role that financial incentives had in that process and the subsequent research that refuted the recommendations of Amgen and Johnson & Johnson.
Furthermore, the idea that they didn't "have “clinical benefit” besides elevating a statistic for red blood cell count" sounds kind of odd, especially if your count is dangerously low.
I honestly don't see how you could read the article and write that sentence. The commentary on the overstated clinical benefit made in the article does not refer to patients with severe anemia. Rather, it refers to the concept that "more is better" that was being promoted at the time by the drug manufacturers. And when Amgen funded a trial to explore this concept, it halted the trial because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-hematocrit group. But when they published the results, they wrote that the rate of death was not statistically higher in the higher-dose group. In other words, they terminated a clinical trial before the numbers that demonstrated specifically how it should not be used reached statistical significance. Which is actually a good thing for the safety of the patients in the trial, but to then continue recommend using higher dosages because there isn't any evidence that it's dangerous is pretty abhorrent.
posted by kisch mokusch at 2:16 AM on July 22, 2012 [3 favorites]
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How can you say that? Just a line later, you say:
drugmakers had seen billions in profits over 22 years
Clearly that made the drugmakers feel better and improved their survival, so stop being a Grumpy Gus! Sometimes the only cure for a patient's condition is a complete cashectomy!
posted by GenjiandProust at 1:37 PM on July 21, 2012 [5 favorites]