This is what's wrong with monopoly.
Mar. 14th, 2011 04:11 pm![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
pecuniumIt's also part of why our system of allocating medical treatments is so screwed up.
Are you pregnant? Is your partner pregnant? Are you planing to be in either of those states?
If either of the above applies to you, is it going to a "high risk" pregnancy, in terms of premature birth?
Are you in the US.
If so have you got an extra $30,000 dollars?
There is a progesterone treatment, recommended for such conditions. In a bit of clever finagling KV Pharmaceuticals got the FDA to give it exclusive permission to manufacture the drug.
It was being made by compounding pharmacies; places with pharmacists who actually make drugs to order. To get shots made up, ran about $10 a pop for 17-hydroxyprogesterone caproate which is a progesterone derived drug.
This is what KV Pharmaceuticals has to say about themselves: "A specialty pharmaceutical company committed to developing, acquiring and licensing innovative and quality products."
And here is what they have to say about their recent acquisition: Ther-Rx Corporation is fully committed to helping ensure that every woman who needs Makena (hydroxyprogesterone caproate injection) will have access to it. We know how important Makena is to the thousands of mothers who are eligible for this therapy. We understand and share the public's interest in ensuring that every mother – whether insured or uninsured – who needs the medication will be able to access it in an affordable manner. That is why we recently announced a patient financial assistance program (PAP) that reduces the total out-of-pocket costs for qualified patients, and that eliminates out-of-pocket costs entirely for patients whose need is greatest. We appreciate the concerns expressed by multiple audiences, and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country.
Background
Makena (hydroxyprogesterone caproate injection) is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of preterm birth in women who are pregnant with a single baby and who have delivered a baby too early (preterm) in the past. Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Prior to Makena, to the extent medication was available, physicians and the mothers they treated had to rely on hormonal therapy that was "compounded" in individual pharmacies without FDA review, approval, or oversight. Makena, by contrast, is an FDA-approved drug, which is manufactured in an FDA-regulated and FDA-compliant sterile facility to ensure quality and consistency from dose to dose.
This is what a doctor had to say about it.
"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York. (from ABC News).
What was the previous risk of this, "non FDA regulated/compliant sterile facility,"?
17-hydroxyprogesterone caproate is safe at least according to a study concluded in 2007, based on uses of the non-"commercially" available drug when Squibb stopped making it in 1999. It's been in use since 1959.
So why the push for reserving it to KV? It might be the 20 doses normally used in treating the women who need it. What's the profit margin on something which a compounding pharmacy could afford to make, and sell at a profit, for $10, when the price is jacked up to $1,500?
The problem is, this is a captive market. Nothing stopped any manufacturer from building a better mousetrap, and making the drug to the specs KV is touting. One assumes that,were it significantly better, physicians would prefer it.
This, however is profiteering. There's no R&D to worry about. No tests, no trials. No worry that some hidden side effect is going to show up in 20-some years and cost them a bundle in unforeseen liability.
The drug was designed on the taxpayer's dime. "All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine."
Lest we forget, the cost of delivering a baby, is somewhere between 5-10,000. That's the whole kit-and-kaboodle. Labor room, drugs, nurse, OB/Gyn. This is 3-6 times what a normal delivery costs (be it C-section, or not).
Why? Because they can.
Once the FDA puts a drug into the category they did, the pharmacies aren't allowed to make them up anymore, and this is the only game in town.
KV says it will subsidize people, but the details are not completely worked out. How long, one wonders, will the evaluation of need take? More to the point, the breakdown they plan to use means that 80 percent of the families in the country will be eligible for their assistance program.
The cost of treatment went from $200, which was affordable, out of pocket, for pretty much everyone, to $30,000. What insurance company is going to be willing to cover that? Who, in the 12 percent who are in the 100,000-149,999 bracket can afford to spend that much of their income, in addition to present costs of having a child.
This is case of a private corporation exploiting a regulation to screw the public. It's what we get from having a "for profit" model of everything.
Are you pregnant? Is your partner pregnant? Are you planing to be in either of those states?
If either of the above applies to you, is it going to a "high risk" pregnancy, in terms of premature birth?
Are you in the US.
If so have you got an extra $30,000 dollars?
There is a progesterone treatment, recommended for such conditions. In a bit of clever finagling KV Pharmaceuticals got the FDA to give it exclusive permission to manufacture the drug.
It was being made by compounding pharmacies; places with pharmacists who actually make drugs to order. To get shots made up, ran about $10 a pop for 17-hydroxyprogesterone caproate which is a progesterone derived drug.
This is what KV Pharmaceuticals has to say about themselves: "A specialty pharmaceutical company committed to developing, acquiring and licensing innovative and quality products."
And here is what they have to say about their recent acquisition: Ther-Rx Corporation is fully committed to helping ensure that every woman who needs Makena (hydroxyprogesterone caproate injection) will have access to it. We know how important Makena is to the thousands of mothers who are eligible for this therapy. We understand and share the public's interest in ensuring that every mother – whether insured or uninsured – who needs the medication will be able to access it in an affordable manner. That is why we recently announced a patient financial assistance program (PAP) that reduces the total out-of-pocket costs for qualified patients, and that eliminates out-of-pocket costs entirely for patients whose need is greatest. We appreciate the concerns expressed by multiple audiences, and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country.
Background
Makena (hydroxyprogesterone caproate injection) is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of preterm birth in women who are pregnant with a single baby and who have delivered a baby too early (preterm) in the past. Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Prior to Makena, to the extent medication was available, physicians and the mothers they treated had to rely on hormonal therapy that was "compounded" in individual pharmacies without FDA review, approval, or oversight. Makena, by contrast, is an FDA-approved drug, which is manufactured in an FDA-regulated and FDA-compliant sterile facility to ensure quality and consistency from dose to dose.
This is what a doctor had to say about it.
"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York. (from ABC News).
What was the previous risk of this, "non FDA regulated/compliant sterile facility,"?
17-hydroxyprogesterone caproate is safe at least according to a study concluded in 2007, based on uses of the non-"commercially" available drug when Squibb stopped making it in 1999. It's been in use since 1959.
So why the push for reserving it to KV? It might be the 20 doses normally used in treating the women who need it. What's the profit margin on something which a compounding pharmacy could afford to make, and sell at a profit, for $10, when the price is jacked up to $1,500?
The problem is, this is a captive market. Nothing stopped any manufacturer from building a better mousetrap, and making the drug to the specs KV is touting. One assumes that,were it significantly better, physicians would prefer it.
This, however is profiteering. There's no R&D to worry about. No tests, no trials. No worry that some hidden side effect is going to show up in 20-some years and cost them a bundle in unforeseen liability.
The drug was designed on the taxpayer's dime. "All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine."
Lest we forget, the cost of delivering a baby, is somewhere between 5-10,000. That's the whole kit-and-kaboodle. Labor room, drugs, nurse, OB/Gyn. This is 3-6 times what a normal delivery costs (be it C-section, or not).
Why? Because they can.
Once the FDA puts a drug into the category they did, the pharmacies aren't allowed to make them up anymore, and this is the only game in town.
KV says it will subsidize people, but the details are not completely worked out. How long, one wonders, will the evaluation of need take? More to the point, the breakdown they plan to use means that 80 percent of the families in the country will be eligible for their assistance program.
The cost of treatment went from $200, which was affordable, out of pocket, for pretty much everyone, to $30,000. What insurance company is going to be willing to cover that? Who, in the 12 percent who are in the 100,000-149,999 bracket can afford to spend that much of their income, in addition to present costs of having a child.
This is case of a private corporation exploiting a regulation to screw the public. It's what we get from having a "for profit" model of everything.
