More on that Drug Company
Mar. 14th, 2011 08:43 pm![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
pecuniumSo, the rationale they made for getting complete control over the drug was that it would, to quote them, "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."
Ok, there is, perhaps, some rationale to that. At Corante (a blog written by a pharmaceutical researcher) there is some discussion about the merit's of that line of reasoning. It's moderately persuasive until one realises he thinks the entire treatment costs $1,500.
He didn't notice the need for roughly 20 injections.
The real gem however shows up in comments (they have some of the problems one finds in comments, but not terribly so; it's not like reading them in an online newspaper), where someone links to the details of this years 10-Q.pdf.
The interesting details are on page 11. It seems there was a bit of a problem with the labeling of some drugs. The CEO fled to Israel, which meant he was spared a felony charge (because of how Israel's extradition works), and he got a sentence of 30 days, but if she reports quickly enough he'll be let out in less than that so he can be with his family for Passover, in Israel, where he'll finish out his probation.
What was the "mislabelling"?
KV Pharmaceutical manufactured generic prescription drugs, including morphine sulfate, a pain relief and opiate drug. Prosecutors said Hermelin decided to increase production of the drug, from an average 4.1 million daily doses in 2006 to 10.6 million in April 2008.
Later in 2008, the company shipped oversized tablets to retailers in California and Canada that were falsely labeled as having the same strength as the regular morphine sulfate tablets -- they actually had more of the active ingredient. KV also received complaints from consumers concerned about oversized and irregularly-shaped drug tablets, the U.S. Attorney's office in St. Louis said.
Prosecutors said the California morphine tablets weighed more than twice the amount they were supposed to, and the Canada morphine tablets were 65 percent stronger than the label claimed. KV's own safety assessment from May 2008 concluded that oversized morphine tablets raised potential safety concerns, including the possibility of an overdose that could cause a coma or death. (Business Week).
Here's the money quote, from page 11, of the 10-Q.
"The Company does not expect to generate any significant revenues until it resumes shipping more of its approved products or until and unless the Company begins to generate significant revenues from the sale of Makena™"
So, they aren't allowed to make/sell the drugs which were their bread and butter because they 1: made them incorrectly, and 2: lied about it to the FDA.
KV's wholly owned subsidiary, Ethex Corp., pleaded guilty in March 2010 to two felony counts of criminal fraud for failing to report to the Food and Drug Administration that it was making oversize painkillers — and drew $27.6 million in fines and restitution. .
Yes, I said lied. It may have been a lie of omission, but they represented themselves to the FDA as not having screwed up. Not having screwed up on a drug that might have killed people.
This does not make me think well of them. They found a drug with a track record, and a need, and they picked it up; when they knew they were about to have a cash flow problem, of an indefinite period, and they decided to use it to carry them over to the time they could sell other drugs. They did this on the claim they could do precisely what they had failed to do with another drug.
They then chose to take advantage of people who have no other choice, by choosing a drug needed by desperate people, and making it so obscenely expensive no one can afford to pay for it, which means we all will, because you can bet Aetna, Blue Cross, etc., will pass it along, and everyone will pay the bill.
Ok, there is, perhaps, some rationale to that. At Corante (a blog written by a pharmaceutical researcher) there is some discussion about the merit's of that line of reasoning. It's moderately persuasive until one realises he thinks the entire treatment costs $1,500.
He didn't notice the need for roughly 20 injections.
The real gem however shows up in comments (they have some of the problems one finds in comments, but not terribly so; it's not like reading them in an online newspaper), where someone links to the details of this years 10-Q.pdf.
The interesting details are on page 11. It seems there was a bit of a problem with the labeling of some drugs. The CEO fled to Israel, which meant he was spared a felony charge (because of how Israel's extradition works), and he got a sentence of 30 days, but if she reports quickly enough he'll be let out in less than that so he can be with his family for Passover, in Israel, where he'll finish out his probation.
What was the "mislabelling"?
KV Pharmaceutical manufactured generic prescription drugs, including morphine sulfate, a pain relief and opiate drug. Prosecutors said Hermelin decided to increase production of the drug, from an average 4.1 million daily doses in 2006 to 10.6 million in April 2008.
Later in 2008, the company shipped oversized tablets to retailers in California and Canada that were falsely labeled as having the same strength as the regular morphine sulfate tablets -- they actually had more of the active ingredient. KV also received complaints from consumers concerned about oversized and irregularly-shaped drug tablets, the U.S. Attorney's office in St. Louis said.
Prosecutors said the California morphine tablets weighed more than twice the amount they were supposed to, and the Canada morphine tablets were 65 percent stronger than the label claimed. KV's own safety assessment from May 2008 concluded that oversized morphine tablets raised potential safety concerns, including the possibility of an overdose that could cause a coma or death. (Business Week).
Here's the money quote, from page 11, of the 10-Q.
"The Company does not expect to generate any significant revenues until it resumes shipping more of its approved products or until and unless the Company begins to generate significant revenues from the sale of Makena™"
So, they aren't allowed to make/sell the drugs which were their bread and butter because they 1: made them incorrectly, and 2: lied about it to the FDA.
KV's wholly owned subsidiary, Ethex Corp., pleaded guilty in March 2010 to two felony counts of criminal fraud for failing to report to the Food and Drug Administration that it was making oversize painkillers — and drew $27.6 million in fines and restitution. .
Yes, I said lied. It may have been a lie of omission, but they represented themselves to the FDA as not having screwed up. Not having screwed up on a drug that might have killed people.
This does not make me think well of them. They found a drug with a track record, and a need, and they picked it up; when they knew they were about to have a cash flow problem, of an indefinite period, and they decided to use it to carry them over to the time they could sell other drugs. They did this on the claim they could do precisely what they had failed to do with another drug.
They then chose to take advantage of people who have no other choice, by choosing a drug needed by desperate people, and making it so obscenely expensive no one can afford to pay for it, which means we all will, because you can bet Aetna, Blue Cross, etc., will pass it along, and everyone will pay the bill.
