Supply of a Cancer Drug May Run Out Within Weeks

[IDemo]

By GARDINER HARRIS
Published: February 10, 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.

“This is dire,” said Valerie Jensen, associate director of the Food and Drug Administration’s drug shortages program. “Supplies are just not meeting demand.”

The drug is methotrexate, and the cancer it treats is known as acute lymphoblastic leukemia, or A.L.L., which most often strikes children ages 2 to 5. It is an unusually virulent cancer of white blood cells that are overproduced in bone marrow and invade other parts of the body.

The cancer commonly spreads to the lining of the spine and brain, and oncologists prevent this by injecting large quantities of preservative-free methotrexate directly into the spinal fluid. The preservative can cause paralysis when injected into the spinal column, so cannot be used for this disease. Methotrexate is also used to treat rheumatoid arthritis.

http://www.nytimes.com/2012/02/11/health/policy/supply-of-methotrexate-a-cancer-drug-may-run-out-soon.html?ref=health

[eShirl]

1. "childhood leukemia" "largely curable" "thousands of children at risk of dying"

THIS is one of many issues Health Care Reform should be adressing!

[MiniMe]

2. Heard this on the news last night

And they described the drug as "low profit" because it is a generic. So big pharma isn't taking the time to produce the drug because they don't make enough money on it. I am beyond disgusted by this.

[aquart]

4. So a free market kills children.

The free market regulates by death. A child's death means nothing unless there are so many that the people rise up. Then something is done. When the bodies are piled high enough. The same way we get a traffic light on the corner.

[MiniMe]

5. Talk about death panels

[corkhead]

17. the "invisible hand" will ultimately lower demand if it is unavailable long enough

[sharp_stick]

10. Yup the big pharma

boogeyman strikes again. This drug has been manufactured for decades by dozens of generic companies. Blaming big pharma is pretty much flailing at something that you don't understand.

Blame the generic companies that don't make enough of it or even more importantly blame the damned generic company that got caught with shitty manufacturing practices. It's not like the generic companies are making this stuff out of simple human kindness.

MTX without preservative is not widely used, and not really used at all outside of cancer infusions, it does not have a long shelf life and so is pretty much made on an as needed basis. This company got caught and poof there goes a pretty big dose of supply, big pharma has nothing to do with it.

[drm604]

14. Sure, if you define the term "big pharma" so as to exclude the companies that caused the problem,

then I suppose that "big pharma" is off the hook. But it seems like a meaningless distinction and a cheap rhetorical trick used to win an argument.

The problem seems to be that some pharmaceutical companies don't make enough or are careless. End of story. Whether or not you consider them to be part of "big pharma" is a semantics quibble.

[i own my story]

20. That doesn't strike you as a bit odd?

"Careless?" Really? Why would they be? They stand to make big $$$$$. Same with not making enough. They pull that crap about flu shots. But since this is Big Business they know that limiting supply makes the demand go thru the roof.

Ah, for the better. Stop poisoning these poor kids with such strong toxins.

[drm604]

21. Well, the story says that in this case it was because of quality control problems.

That may or may not be the case but I have to give them the benefit of the doubt on this.

Certainly companies do restrict production in order to increase the price, and it's a despicable practice when it's a drug company, but reducing production to nothing kills off all profit so it doesn't seem likely in this case.

I'm certainly not defending the company. If they had quality control probems, that's bad. For a drug company to have quality problems is unforgivable.

[DeSwiss]

23. I understand needless death. That's enough. n/t

[tech_smythe]

26. THIS is why the government needs to manufacture it's own drugs

these assholes want competition, then I say the government should produce generic drugs
not only that, but A N Y drug the government has put funding into
that INCLUDES drugs made or discovered/developed in universities, since they ALL take government funds.
let them sell their boner pills, but the government should have a hand in making drugs the rest of us need to survive!

[MADem]

32. That's the easiest way to ensure crappy production processes and cost overruns.

There's absolutely zero incentive to get it right the first time.

It's fine to place regulatory controls on the manufacturers, but we don't need to get into the "Gubmint Drug Making Business."

[tech_smythe]

33. the government is actually very efficient, just slow

the drugs they would make would all be guaranteed up to snuff... you know... being the government and all

[MADem]

34. No it isn't. DOD cannot account for TRILLIONS over the years.

Waste and mission creep are simply inevitable.

Oversight is good. Doing the job in a nationalized entity, absent a world war, is not.

[marmar]

3. "Prices for some have risen as much as eightyfold."

Makes you wonder if this is one of those "accidentally on purpose" shortages.

[Celebration]

6. hey, wait a minute!!!

We don't want this in "creative speculation" do we?

[nobodyspecial]

7. Yep

Free market is fine for wants like designer handbags, electronics or home furnishings. But when it comes to needs, like lifesaving drugs, regulation is needed. They often have shortages of vaccines as well -- anything that doesn't have a high profit margin.

[Thor_MN]

9. Actually, it's due to the way it is supplied

Oncologists both prescribe and sell cancer drugs. Pharmacies are not involved. So, more profit to retail expensive, brand name drugs than generic methotrexate. So less demand, producers stop making it/make less. And that comes arond to bite people who need it.

If conspiracies were involved, I'd drag its use to treat ectopic pregnancy into play. What could be more evil than corporations that are willing to let children with cancer die to prevent the termination of a pregnancy that couldn't possibly survive to term and could kill the mother?

[Historic NY]

11. Thats the strange part if everyone is making it...

sure makes you wonder.

[zbdent]

18. somehow I doubt it's due to wages rising for

the lower rungs on the ladder at the "producers" ...

[slackmaster]

8. I couldn't find the National Lampoon photo of Nelson Rockefeller about to flush a cancer cure, so...

...I'll just post this instead. In that issue of the 'poon were several photos of Nelson Rockefeller extorting people in various ways. One showed an emaciated man in a wheelchair desperately trying to stop Rockefeller from dropping medication into a toilet. The caption indicated that the medicine would have cured the sick man's cancer.

[OVERPAID01]

12. Drug shortages

The way this works is:

1. Politicians say expensive drugs are necessary because pharmacies spend a lot of money on research and need to make their money back and be profitable.

2. Republicans and unfortunately most Democrats say generic drugs should not be allowed "you just don't know what is in a generic drug".

3. This is a green light for the pharmacies to buy out the manufactures or collude with them in exchange for a share of the profits of the pricey designer label drugs to stop making generis drugs.

4. Result is flu shots are in short supply, specific designer drugs are in short supply, and the big pharmas continue their monopoly by charging what ever they want in an unregulated market.

[Highway61]

13. "This is Dire"

As we discussed this past week in this post:

http://www.democraticunderground.com/1002283611

I worked all my life as a nurse and saw up close and personal what happens. It happened rather slowly over time but as of today I can say it is blatantly right in your face. There is way too much money to be made...they are not interested in a cure. Think about it, one will pay and do ANYTHING to save their/or a loved one's life. The ultimate money maker. Believe me, If you had a load of money there will be no drug shortage for you. Those who don't....oh well. It's my opinion, but I am not far off the mark.

[originalpckelly]

15. We need to have a two tiered state and private drug manufacturer system.

Drugs that are newer should be made and marketed by for-profit companies, while drugs like this should be made by a foundation or state owned enterprise. I lean toward a co-op of healthcare providers who need this stuff just to make things work, and have little motivation to jack up the price to make it expensive.

[sulphurdunn]

16. Obama signed

his executive order on October 31st to correct this. In China a few Big Pharma CEOs would have been taken out and shot on October 31st, and there would be no shortage of the drug today or concerns about children dying for lack of it.

[Dreamer Tatum]

19. This used to be so simple - just blame Bush.

Oh well.

[progressiveinaction]

29. Still Bush's fault anyway.

Has to be.

[sarcasmo]

22. Short pills and then jack up the price, big pharma way.

Give me the Canadian system any day. I am so tired of for profit health care.

[laundry_queen]

37. guess what?

Our pharma system is basically the same as yours, except with price controls. We get the same shortages and crap. It's basic care that's covered - not meds (except for most seniors and low income kids).

[sarcasmo]

39. I will take free care. My friend lives between Tornto and Ottawa has four

kids and does not worry about the kids health care.

[laundry_queen]

41. No shit.

Did you think I was implying something different with my post? We should ALL have free (at the point of service) care AND have our meds covered in the same way. All of us.

[blm]

24. Please spread this far and wide. We MUST do everything we can to address this outrage.

Corporate death panels...in AMERICA.

[tawadi]

25. They halted manufacturing because of “significant manufacturing and quality concerns”?

I smell BS.

[blm]

27. funny, you'd think we'd have heard about a recall of defective product by now, eh?

.

[rexcat]

30. This happens more than most people think..

Methotrexate (preservative free) has been recalled three times since 2007 per the FDA web site (www.fda.gov). It is not uncommon to have drug manufacturing halted because of quality concerns. If the drug does not meet the specifications the companies are obligated to inform the FDA and stop production. All lots of drug are tested for purity and quality during the manufacturing process. I can assure you they would rather be manufacturing the stuff to sell than have the production lines stopped. No drug, no money for the pharma companies. These companies like money.

You speak of things you know nothing about.

[AdHocSolver]

31. Drug companies have had four-plus years to work the bugs out of the manufacturing process.

According to the original NYTimes article:

(snip)
**********
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...
**********

Some drug companies evidently have made out like bandits from drug shortages.

[rexcat]

36. If you would bother to go to the FDA web site...

and look at the recalls over the years it happens all the time. There can be a manufacturing glitch, a change in suppliers for ingredients, etc. The making of these drugs in not easy chemistry and, unfortunately shit occasionally happens. It is not like adding ingredient A, B and C to get a product. I worked in an R&D facility (diagnostics company) and manufacturing issues were common. Diagostics are in most cases easier to manufacture than drugs. The more complicated the process the more manufacturing issue will pop up.

For full disclosure I work in Pharam (research side, not manufacturing) and for the most part people who work for these companies want to do the right thing. If they are being told to screw things up to decrease the amount of a particular drug on the market a whistleblower will come foward. As an "insider" I would not trust the CEOs in these companies as far as I could throw them but that goes for any corporation.

One of my concerns is the lack of real oversight by the FDA at the manufacturing facilities. The FDA and the Pharma companies are too close to each other. It is not uncommon for FDA officials to end up working for the Pharma companies in some capcity after they leave the agency.

As far as pricing goes the US is a "free market" and they take advantage of it. I have seen pricing that makes absolutely no sense. In Canada, Mexico, EU, etc. drug prices are regulated. The regulation of drug prices is up to debate in this country but I don't see this changing anytime in the near future. If we ever go to singl-payer health care in this country then there will be some regulation of drug pricing in the US. Also the drug companies are free to dictate what drugs and what quanity they will manufacture. Until the government regulates this things won't change.

It is great to bitch about these issues but how about some constructive criticism along with some solutions to the problems. Unfortunately that would require people to know the issues and, for the most part, I don't see that on DU.

on edit see post 35.

[valerief]

28. Methotrexate, the new oil. I hope this gets corrected. I have a dear friend who depends on this. nt

[midnight]

35. Health care treatment is provided as long as it's profitable. It's the money trumps peace principle.

[laundry_queen]

38. Methotrexate is used for many things

not just leukemia. RA and ectopic pregnancies are 2 of those things. It won't just be kids with A.L.L. dying. This is a really serious situation.

[tabasco]

40. The wealthy don't have to worry

They'll get their shit.