Supply of a Cancer Drug May Run Out Within Weeks

[davidm]

Supply of a Cancer Drug May Run Out Within Weeks (Published 2012)

A crucial medicine to treat childhood leukemia is in such short supply that hospitals across the country may exhaust their stores within the next two weeks, leaving hundreds and perhaps thousands of children at risk of dying from a largely curable disease, federal officials and cancer doctors say.
…
Jackson Schwartz, 6, of Langhorne, Pa., received a diagnosis of A.L.L. in August after he complained of terrible stomach pains and spent much of his family’s vacation sleeping on the beach, said his father, Jon Schwartz. A doctor initially gave Jackson a diagnosis of constipation, but when the constipation medicine did not ease his symptoms, Jackson’s parents took him to Children’s Hospital of Philadelphia.

Within a day, doctors started Jackson on methotrexate, and the drug has been an essential part of his treatment ever since. Jackson is scheduled to have methotrexate injected into his spine weekly for the next eight weeks to ensure that his cancer does not return. If the hospital is unable to get more supplies, however, Jackson’s treatment and life may be in serious jeopardy, Mr. Schwartz said.
…
So far this year, at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections and other diseases have been declared in short supply — a record number. Prices for some have risen as much as eightyfold. President Obama issued an executive order in October to help ease the problems.

So, what could be done to prevent this kind of thing from happening?
Should the government fund the production of these medicines?
Should we let the free market decide which children live and die?
Should we remove anything that may constrain the prices of these drugs (which, presumably, would increase production) and live by “survival of the richest”?
What, can be done about these kinds of problems?

I’m waiting for someone to post that it’s their fault for getting leukemia or for being born to parents who were so lazy that they’re not now multimillionaires who can buy what they need on the black market. I wouldn’t consider it a constructive addition to the conversation, but I won’t be surprised if it happens.

[John_Mace]

Also in short supply are drugs to prevent Poisoned Well syndrome.

As for what should be done, from your cite:

There are four other manufacturers of methotrexate in the United States, and they are trying to increase production, Ms. Jensen said. The F.D.A. is also seeking a foreign supplier to provide emergency imports until the approved domestic ones can meet demand, she said.

“We’re working on many fronts, and will keep this a priority,” Ms. Jensen said.

[Nava]

@davidm

Should we remove anything that may constrain the prices of these drugs (which, presumably, would increase production) and live by “survival of the richest”?

Don’t assume that would increase production: keeping production restricted is a marketing strategy, and it’s not merely theoretical.

Also, increasing production of a drug is likely to be a lot more complicated than increasing it for, say, jam (to pick something else which should have similar care in its production). I do hope other pharma companies are more efficient, but in the one for whose Logistics department I worked, a pill with just three ingredients might involve upwards of 20 factories - and while the process could have two or more steps which took place in the same country, they wouldn’t be sequential.

[davidm]

@John_Mace

Also in short supply are drugs to prevent Poisoned Well syndrome.

As for what should be done, from your cite:

Yes, but it also says that those things may be too little too late for some people.

How do we prevent these issues in the future? Should important but less common and highly perishable drugs receive some kind of special treatment? If so, what? I don’t know what the answer is and I’m curious about what others think. And I *am * open to reasonable free market solutions if they make sense. However, I would also consider some kind of regulatory solutions if those makes sense. I suspect that the “best” answer will be somewhere in between.

That said, I’m not interested in the type of hardcore Libertarian types of responses that are posted by a few on this board. Those aren’t answers to the problem, they’re simply sweeping it under the rug. If you consider my saying that to be “poisoning the well” that’s your right.

[even_sven]

@davidm

So, what could be done to prevent this kind of thing from happening?
Should the government fund the production of these medicines?
Should we let the free market decide which children live and die?
Should we remove anything that may constrain the prices of these drugs (which, presumably, would increase production) and live by “survival of the richest”?
What, can be done about these kinds of problems?

I feel bad for the kid and his family, but this isn’t exactly a new problem. Nine million children die every year of easily preventable diseases. Heck, we have a vaccine for the top reason why kids die (pneumonia), and the second largest- diarrhea- can be solved with freaking water. Malnutrition contributes to a fifth of childhood deaths. People die because they can’t get stuff you can find at 7/11.

Lack of high-level cancer drugs is a bummer, but it’s a drop in the bucket if you are talking about “survival of the richest.”

[davidm]

@Nava

Don’t assume that would increase production: keeping production restricted is a marketing strategy, and it’s not merely theoretical.

Also, increasing production of a drug is likely to be a lot more complicated than increasing it for, say, jam (to pick something else which should have similar care in its production). I do hope other pharma companies are more efficient, but in the one for whose Logistics department I worked, a pill with just three ingredients might involve upwards of 20 factories - and while the process could have two or more steps which took place in the same country, they wouldn’t be sequential.

Interesing point about the intentional restriction of marketing. I assume that’s done to increase the price, is that correct?

You were in the industry; what, if anything, can be done about that? Public shaming of the individuals making those kinds of decisions? That’s not a totally tongue-in-cheek question. Protests do get attention, as we’ve seen recently.

I know some will say that we shouldn’t try to interfere with the decisions of a public (or private) corporation, but I don’t have a problem with a society having certain ethical standards and attempting, through legal and nonviolent means, to hold their members to those standards.

Someone who intentionally holds back production of life saving medications in order to increase profits should find it difficult to show their face in polite society just as a racist or a misogynist would.

That said, I don’t know of any proof that in this case production is intentionally held back.

[davidm]

@even_sven

I feel bad for the kid and his family, but this isn’t exactly a new problem. Nine million children die every year of easily preventable diseases. Heck, we have a vaccine for the top reason why kids die (pneumonia), and the second largest- diarrhea- can be solved with freaking water. Malnutrition contributes to a fifth of childhood deaths. People die because they can’t get stuff you can find at 7/11.

Lack of high-level cancer drugs is a bummer, but it’s a drop in the bucket if you are talking about “survival of the richest.”

Why do people seemingly use “Not a new problem” as a synonym for “let’s do nothing about it”. Maybe I’m misunderstanding you?

[Simplicio]

I suspect the drug is funded by the gov’t, in that the gov’t pays for the majority of healthcare in this country, and so probably the majority of methotrexate.

The problem seems to be a supply disruption at a particular plant, but the explanation for why the plant closed is pretty vague. “significant manufacturing and quality concerns,” could mean about anything. Its kind of hard to say what a good solution to the problem would be though, without knowing what the problem that caused the disruption was.

[John_Mace]

@Simplicio

The problem seems to be a supply disruption at a particular plant, but the explanation for why the plant closed is pretty vague. “significant manufacturing and quality concerns,” could mean about anything. Its kind of hard to say what a good solution to the problem would be though, without knowing what the problem that caused the disruption was.

Yeah, that was my thought as well. This is one of those things, like this other thread, that is a sad story, but lacking enough details to take an informed position on.

@davidm

That said, I’m not interested in the type of hardcore Libertarian types of responses that are posted by a few on this board. Those aren’t answers to the problem, they’re simply sweeping it under the rug. If you consider my saying that to be “poisoning the well” that’s your right.

You don’t get to pick which types of arguments you have to deal with, and it’s not just my right to call it poisoning the well, I am right, because it absolutely is.

If you don’t want to get called on it, don’t do it.

[even_sven]

@davidm

Why do people seemingly use “Not a new problem” as a synonym for “let’s do nothing about it”. Maybe I’m misunderstanding you?

Mostly I guess I’m hoping to encourage people to think a lot wider about issues of drug manufacturing, costs, and the question of who lives and who dies.

I think the questions that you are asking are a lot bigger than they seem at first.

[davidm]

This whole thing hits a little close to home to me. I take an injectable medication which is not available in regular pharmacies or even in hospitals. I have to get it through mail order from a specialty pharmacy.

The stuff costs hundreds of dollars for a 30 month supply, and I pay half of that.

I have to get a new supply every month or so. For years, it wasn’t an issue. Over the past few years I’ve been running into supply problems. They never have it in the dosage form most suitable for me. Sometimes they can find a supplier that has it in ampules, which require special filter syringes. Sometimes they only have it in a much higher concentration in multi-use vials, which requires a much smaller dose. All of these changes in container, dosage, and types of syringes require a new prescription from my doctor as well as new training for me in how to use it. So far, they’ve always been able to supply it in one form or another, but it nags at me constantly that one day they won’t be able to fill my prescription in any form or at any cost

To be clear; not having it won’t kill me. At least not directly. It could, however, make it difficult for me to hold down my job, and thus maintain my insurance (as well as paying for life’s usual day to day necessities), and I suppose not having it could wear down my body’s defenses over time. But I’m not in any way comparing myself to a dying child.

I’m saying all of this to point out the effect this kind of situation has on people. It’s emotionally difficult on me. I can’t even imagine what it must be like for a dying child and that child’s parent.

[davidm]

@John_Mace

You don’t get to pick which types of arguments you have to deal with, and it’s not just my right to call it poisoning the well, I am right, because it absolutely is.

If you don’t want to get called on it, don’t do it.

I can’t control what people post, but the point of this thread is to explore solutions. I can set try to set the parameters of the debate and people are certainly free to ignore those parameters. I’m also free to ignore those people. (By ignore, I don’t mean the forum’s “ignore” function. I’ve never used that. I just mean ignore certain posts in certain threads.)
I’m also free to stop responding to “meta” posts about how I started the debate. I may just do that, with no offense intended.

[Thudlow_Boink]

@Simplicio

The problem seems to be a supply disruption at a particular plant, but the explanation for why the plant closed is pretty vague. “significant manufacturing and quality concerns,” could mean about anything. Its kind of hard to say what a good solution to the problem would be though, without knowing what the problem that caused the disruption was.

My thought exactly. I don’t know how to answer the OP’s question of “How can we prevent this sort of thing from happening?” without knowing what causes this sort of thing to happen.

[Theobroma]

Gosh. You’re just noticing this now? Drug shortages have exploded over the last few years, with cancer drugs and critical care drugs hit particularly hard.

There are a number of causes, from the FDA closing one plant and the remaining plants being unable to keep up with demand, to raw material issues, to a company simply no longer manufacturing a medication because fixed reimbursements make it impossible to manufacture and sell without taking a loss. Most of the shortages are for drugs that are not expensive and have been around forever. Methotrexate has been around since about 1950.

In the hospital pharmacy where I work, we have, I don’t know, a hundred backorders in? And it’s all for inexpensive, older drugs that are on national shortage. We are substituting as best we can, but supply of the most common substitutes dry up eventually, because everyone is using them.

Methotrexate is certainly thin on the ground right now, but at least I got in some Taxol (commonly used for breast cancer, and we nearly ran out a few months ago). Within the last year and a half or so, we ran out or nearly ran out of Carboplatin (lung cancer and many others- I was down to my last vial), Cisplatin for og’s sake (used for nearly everything), Leucovorin, Mesna, Bleomycin (we had to do without for months), Adriamycin (breast cancer, leukemia, and Hodgkins’- down to 2 vials before the shortage resolved somewhat and we could buy some), Fluorouracil (colorectal, head & neck), Cytarabine (leukemia), Doxil (Kaposi’s sarcoma/ovarian, all stock long gone) and on and on and on. I hope we can get some vinblastine in before I use up my last three vials. I have several patients who need it.

I can’t begin to tell you how frustrating it is. Sometimes one purchasing group will get backorders partially filled and another won’t. At least I’m not the one who has to try to explain this to the patients. I keep the oncologists posted as much as I can. We’re always trying to set up backorders and call and beg for a few vials if there are any on allocation. We barely keep up. Our buyer is awesome, but she’s pulling her hair out.

If you’re interested, here’s a link from the FDA about the drug shortages. There’s a link on the page with a list of the drugs currently on shortage. Sometimes the release dates are a little, um, optimistic. Sometimes we get lucky.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

I repeat: virtually NONE of these are expensive drugs. My understanding (which may be incorrect) is that the drug companies couldn’t jack up the price if they wanted to because Medicare has fixed the reimbursements in an effort to contain drug costs. That’s why the drugs on shortage are seldom the expensive moneymakers like Avastin, Herceptin, etc. It’s all those old generic things I mentioned. And starting up a new factory line to make medications to FDA specs, which are incredibly strict, can take many months.

What can be done? I don’t know…they’re talking about a law that would require manufacturers to notify the FDA when they’re planning to take down a product line, which would help a little bit down the line, maybe. The FDA might be able to clear some more foreign factories for importation, as they did with leucovorin, available from England for a while.

It’s all very frustrating and there are no easy answers. Certainly the FDA can’t order manufacturers to manufacture certain things. I wish I knew the solution.

Theobroma, oncology pharmacist

[yorick73]

Here’s an interesting op-ed from Ezekiel Emanuel that states that price fixing and limiting price increases is the main reason for the shortage of cancer drugs. Much of this was a result of The Medicare Prescription Drug, Improvement and Modernization Act of 2003. No big surprise there.

From the article:

@article

The act had an unintended consequence. In the first two or three years after a cancer drug goes generic, its price can drop by as much as 90 percent as manufacturers compete for market share. But if a shortage develops, the drug’s price should be able to increase again to attract more manufacturers. Because the 2003 act effectively limits drug price increases, it prevents this from happening. The low profit margins mean that manufacturers face a hard choice: lose money producing a lifesaving drug or switch limited production capacity to a more lucrative drug.

The result is clear: in 2004 there were 58 new drug shortages, but by 2010 the number had steadily increased to 211. (These numbers include noncancer drugs as well. )

Another interesting part:

@article

You don’t have to be a cynical capitalist to see that the long-term solution is to make the production of generic cancer drugs more profitable. Most of Europe, where brand-name drugs are cheaper than in the United States, while generics are slightly more expensive, has no shortage of these cancer drugs.

[smiling_bandit]

@Theobroma

Gosh. You’re just noticing this now? Drug shortages have exploded over the last few years, with cancer drugs and critical care drugs hit particularly hard.

I’ve been reading about this for a long time as well, but there seems to be little anyone can do directly.

I repeat: virtually NONE of these are expensive drugs. My understanding (which may be incorrect) is that the drug companies couldn’t jack up the price if they wanted to because Medicare has fixed the reimbursements in an effort to contain drug costs.

I suppose it shouldn’t come as a surprise that if you force people to sell things below cost, they usually won’t. In a similar vein, I’ve been reading about CalPro’s mess over at Angry Pharmacist.

http://www.theangrypharmacist.com/archives/2011/12/shooting-yourself-in-the-foot-10-at-a-time.html

For those not interested in the link, basically California is trying to save costs, and in the processing making drugs more expensive for the pharmacy to fill than it would generate in revenue. This is a fantastic way to cut costs, of course, since you don’t pay pharmacies anything at all for drugs they don’t carry. Then some of the sick people die and you don’t have to pay anything for them.

[spankthecrumpet]

@davidm

I know some will say that we shouldn’t try to interfere with the decisions of a public (or private) corporation, but I don’t have a problem with a society having certain ethical standards and attempting, through legal and nonviolent means, to hold their members to those standards.

It’s funny you should say that, because it’s society’s attempts to enforce said standards that have led to these shortages.

That is a major reason why what I would call pragmatic libertarians (i.e. ones not motivated primarily by ideology) and the like support limited governemnt. Unintended consequences.

[smiling_bandit]

@spankthecrumpet

It’s funny you should say that, because it’s society’s attempts to enforce said standards that have led to these shortages.

Well, that an attempts to impose some kind of odd price controls. I suspect it’s those which had more of an impact than standards.

[Simplicio]

@smiling_bandit

Well, that an attempts to impose some kind of odd price controls. I suspect it’s those which had more of an impact than standards.

They’re not price controls. The drug companies can charge whatever they want. The gov’t won’t pay beyond a certain price though. If I won’t buy a taco if it costs more then four dollars, that doesn’t mean I’m “controlling the price of tacos”, even if I’m the taco cart guys best customer.

I think the main problem is that the prices Medicare pays are fixed by legislation. This means if it turns out they’re underpaying, trying to fix it means it has to go through Congress, which is a tough job at the best of times and more or less impossible these days. The obvious solution, then, is to give Medicare more latitude to adjust allowable payments as market conditions change.

[smiling_bandit]

@Simplicio

They’re not price controls. The drug companies can charge whatever they want. The gov’t won’t pay beyond a certain price though.

Hence I said, “some kind of odd price controls.” As in, not normal price controls. Sure, technically the government doesn’t control the market price, but it does indirectly control a huge amount of the effective demand… exactly as if it had a true price control. The fact that it was through a misapplied cost-saving meaasure doesn’t change the market impact.