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There needs to be an investigation into Ben Venue Laboratories. What exactly does "serious quality control issues" mean? This plays like Ben Venue wanted to take distribution offline to change the supply and demand balance, thereby creating an artificial price hike in the drug. Ben Venue will reenter the market when it suits them. It's Enron all over again. Only this time, children might die. Seriously, this type of activity needs to be taken into account before licensing Ben Venue any other generic drugs to manufacture.
Before you get all riled up, you should probably consider the possibility that a "serious quality control issue" probably means that the batch of drugs they were making was unsafe for use. This is not uncommon, and a drug company cannot afford to ship a contaminated product (that would be an instant game over for them). But hey, if you really believe that there is some fat cat business tycoon who likes to watch kids die in order to make more money, then by all means spread your paranoia.
By FDA inspection report standards, the length of the document alone suggests the magnitude of the quality and manufacturing compliance issues at Ben Venue, an arm of Boehringer Ingelheim. The 33 pages comprise a Form 483 inspection report issued to the company after a May 2011 inspection. Within those pages are 48 counts of GMP violations.
Read more: Ben Venue inspection yields 48 GMP violations - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/ben-venue-inspection-yields-48-gmp-violations/2011-10-19#ixzz1mZ17z2qR
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That's a cartoon, but then the board of directors of GM was more than willing to watch the population and city of Flint MI go down the drain without flinching. Corporations are not people and do not care about people. That's reality and not a cartoon. So the idea that companies would sit on a crucial product in order to boost prices is not exactly a paranoid consideration and hardly surprising. We've had many examples of such things in the past.
What, in part, caused the shortage?
The drug went off patent, which meant generics of it could be sold. When that happened, the price for the non-generic methotrexate fell and fell and fell, thus the drug company couldn't make as much profit, so it dropped the non-generic drug.
To me, just another case of a company looking to the bottom line first and last, and completely ignoring all other factors.
Methotrexate has been used since the 1950's. The shortage had nothing to do with a patent or generics. Methotrexate IS the generic. Please cite your sources if you know otherwise.
The shortage was caused because the API is in short supply, and because the mfgr must gain regulatory approval before it can ramp-up production. Believe me, where there is demand, a company would love to sell a product. Hard to make said product with missing ingredients and regulators limiting your batch quantity.
Given the critical need for the drug, there is no way that the company that shut down its factories should have been able to do so without raising a formal alarm in both industry and the FDA so that other companies could voluntarily or by way of government mandate take up the slack. Are there adults in control of and overseeing the drug industry and regulatory industries or children? I find this entire situation inexcusable.
There were quality and safety issues which immediately stops production. Check ashp.com/shortages for current shortages of drugs and you can also see the history of shortages.
Please let your congress members know that you are in favor of tracking by the FDA, CDC, NIH and others, since certain groups are trying to de-regulate everything, and it may be your own life or health or medication very soon. I apologize if I sound angry, but I actually am very angry! Not at the commenters here, though. I think it is great that you are interested enough to be concerned, so thank you!
Its not like the other companies had unused capacity sitting around that they could just turn on. That would have been wasteful on their part. Its take years to get new capacity approved through the FDA and its too big a cost to then just let it sit idle.
This drug is also used, by injection, for children with Juvenile Rheumatoid Arthritis, which both of our young daughters have... and as with many young cancer patients, the alternative treatments to the preservative-free MTX for Juv Arthritis, are not as effective. Sounds like the drug companies need to get their asses in gear.
Usually the vials used for RA, and other chronic conditions, are not preservative-free so they are not in competition with those used for spinal injections. But I agree with your other ideas! And my sympathies to your daughters. Let's hope for more research and development for effective treatments.
As long as the efforts to ensure the drug is available does not prevent the procuring of even a single rifle to arm a USA soldier who is needed to fight the ruling-class and corporate USA's overseas wars to protect the vital wealth flow to our masters and/or their foreign elite cohorts overseas THEN I am okay with efforts to ensure a drug that assists the commoner scum citizen-sheep underlings can commence.
Don't YOU support the troops?
Love it or leave it.
OBEY!!!!!!!!!!!!!!!
I think you've got that right, and a good sense of humor, too. They understand the Preamble to "provide for the common defence" but don't care so much about "promote the general Welfare". Why bother to make a 10% profit on a life-saving drug when they can make a 500% profit on something else? Stockholders rule!
It DOES say "promote the general welfare", not "provide" it.
Jon, you are correct. Ben Venue (BV)was inspected twice in 2011. Both times deficiencies were identified by the FDA inspectors.
In Nov 2011, BV shut down most of their production activities to address the inspectors observations. In Dec 2011, the facility was voluntarily closed in order to fully dedicate their time and energy to remediation efforts. The stoppage in production and ultimately the closure of the facility was done in full cooperation with and knowledge by the FDA.
The stoppage in production by BV caused an enormous burden on the other companies that were also manufacturing these drugs and they are not able to keep up with the demand.
This information is available to the public through the Freedom of Information act (FOI) on the FDA webpage.
Methotrexate is also used as an injectible drug in adult rheumatoid arthritis. I currently am on this drug and experienced the alarm of my pharmacist calling to say he could not find it anywhere! They did eventually find some but I, too, am more concerned for the children fighting cancer and their families. Maybe the FDA, while doing their job to shut down the producers who have unsafe product, should also do their best to have other producers increase their production to keep the supply even with the demand.
First of all, I do not understand why, if one company closes down, then there is no other back up. My nephew Jack, 18 years old, is fighting leukemia, just diagnosed in September 2011, and has to have the Methotrexate for his treatment or he will not make it. I was glad to read that this may ease up, but we are not out of the woods here. Childrens lives are at stake, as this is 90% cure rate. The pharmaceutical industry needs it's coat taken off. We need investigation into what is going on here. I just read another story about Avastin, a life saving drug, produced in China, with fake drugs coming over. And 80% of drugs are made overseas. We are in dangerous territory, and I hope a reporter blows the lid off of this. This has been going on for several years with chemo drugs. It is about greed and the bottom line, and nobody can tell me it is not.
Please check your facts. 1.) The drug in short supply is the preservative free formula. That is the only one the kids can take. 2.) A.L.L. has a 90% survival rate, not cure rate. There is a huge difference. Cure means that there are no residual effects from the disease. 2/3 of kids who survive experience long-term health problems including other cancers caused by the treatment, hearing loss, IQ loss, and organ failure resulting in death. Kids still die from A.L.L. all the time, a grisly death. There is no sigh of relief in any kids' cancer.
Money again the root of all evil...Why don't they do the right thing and just make it..They will always make a profit, just not the multi billion dollar one they are used to..Government grants cover 62% of medicine research our (taxes)...Its a sick world when you let little kids or anyone die over the almighty dollar.