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Subscribe to RSSAn Ohio drugmaker began releasing limited supplies of a crucial medication to treat childhood leukemia Thursday, sending hospital pharmacists facing life-threatening shortages scrambling for their share.
Jerrod Milton, chief of pharmacy at Children’s Hospital of Colorado, was among those first in line as Ben Venue Laboratories began accepting new orders for the drug methotrexate, three weeks before the hospital would have run out completely.
“I had a tip that it was going to be available,” he said. “I put my pharmacy team on notice.”
Ben Venue officials said product would be allocated starting now and continuing over the next several weeks to oncology clinics, hospitals and pediatric facilities, easing the shortage crisis. No information was available about which sites would get the scarce drugs first, or in what order.
Milton is awaiting the arrival Friday of what he hopes will be 300 250-milligram vials of the widely-used drug to treat acute lymphoblastic leukemia, known as A.L.L., a blood cancer that mostly affects young children. It's a virulent cancer of the white blood cells that spreads to other parts of the body.
The drug is short-dated, meaning it is set to expire in two weeks, but Milton is requesting it anyway to replenish vital supplies of the medication that makes A.L.L curable in about 90 percent of cases, cancer doctors say. The amount and timing of the drug used varies widely according to age, weight and other patient factors. The Colorado hospital has dozens of patients on the protocol.
“It extends our supply by essentially up to a month,” said Milton, who is also his hospital’s vice president of operations. “But it’s still a very uncomfortable place to be.”
News this week that hospitals across the country were within a couple weeks of running out of the critical drug prompted herculean negotiations involving the federal Food and Drug Administration and the five manufacturers of methotrexate. The story was first reported in the New York Times.
Chuck Eaton, facesofhope.org
Justine Seibel, 13, of Fort Mill, S.C., is among thousands of children with acute lymphoblastic leukemia, or A.L.L., who are treated with the cancer drug methotrexate. Reports of dire shortages worry her mother, Christine Farinick.
It also prompted anxiety and anger for parents like Christine Farinick of Fort Mill, S.C., whose 13-year-old daughter, Justine, was diagnosed with A.L.L. a year ago. She has received dozens of treatments of methotrexate and is scheduled for another session in three weeks -- as long doctors can get it.
“Without it, there’s a high rate of relapse,” said Farinick, who is getting a passport and researching ways to obtain methotrexate from suppliers in Europe and Canada if she can’t obtain it in the U.S. “It is available.”
Bedford Laboratories, which runs Ben Venue, worked with the FDA to arrange allocation of strictly limited supplies of the drug. The product was produced before the troubled firm voluntarily shut down its operations in November because of manufacturing and quality problems identified during FDA inspections.
“We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production,” Ben Venue officials said in a statement.
The four other manufacturers of the drug -- Hospira Inc., Mylan Institutional, Sandoz and APP Pharmaceuticals LLC -- indicated they were trying to increase production or work with the FDA to allow production of the preservative-free version of the drug. Methotrexate without preservative is given intravenously or injected into spinal fluid, where preservatives could cause toxic reactions.
Neither Bedford officials nor the FDA would say how much product is available, or how many hospitals would be served. Hospital buyers say they’re being quizzed about patient need and allowed a two-week supply of the drug, said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages.
The new availability is both a relief and a reminder of the seriousness of drug shortages that now number about 287, the most in U.S. history, cancer experts said.
“Every little bit helps, but it’s so wrong that we have to live like this,” said Dr. Harvey Cohen, a professor of pediatrics at the Stanford School of Medicine and a member of the American Society of Hematology’s government affairs committee. After decades of progress in finding the right drugs to treat -- and cure -- A.L.L., not being able to obtain them is a huge setback, Cohen said.
He was waiting to hear Thursday whether he would get an order of 20 grams of methotrexate to treat a 16-year-old boy with a bone tumor on Friday.
“His tumor responded beautifully to the medicine. We know the medicine works,” Cohen said. “We have the orders in. I signed them myself yesterday. I just don’t know if we will get it.”
Cohen said he and his colleagues essentially have to ration the drug, giving highest doses to children with difficult-to-treat cancer and lower doses to those whose condition is easier to treat.
"Given the shortage, we have to be able to give that to the children who will benefit the most," he said.
Some experts are breathing a brief sigh of relief at the stop-gap supplies of methotrexate. Dr. Michael Link, president of the American Society of Clinical Oncology, praised the FDA’s efforts to avert a total shortage.
“The FDA deserves a fair amount of credit for really stepping up to the plate and resolving this for the short term,” he said. “It’s unfortunate that we had to get to a crisis situation.”
Five U.S. senators demanded more information about the problem on Thursday, sending a letter to Ben Venue officials saying patients and providers have been given no timeline for fully resolving the crisis. They asked for more information about the quality problems at Ben Venue that prompted the shutdown, stalling production not only of methotrexate, but other drugs in short supply. The senators asked if reimbursements for the drug, which is a low-profit generic, played a role in the current shortage.
That echoes the concerns of Christine Farinick, who said she believes that low returns are at the root of the problem.
"All the medication shortages are because the drugs are not profitable to make," she said, adding: “I think that’s absolutely disgusting."
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another example of Capitalism at odds with the well being of this country. There are certain issues that a Capitalist system does not benefit society, health care is obviously one of them. The motive should be to help sick people and keep people healthy, not to maximize profits off the backs of kids with cancer, thats despicable! This production shutdown has been going on for nearly 4 months. There is absolutely no legitimate excuse for it to continue for such a long period.
I understand supply and demand and prices etc...but it sounds to me that the FDA is causing more of the limitted supply problems than greed...
You are just noting the comment of one parent that has no evidence to her statement or concern..ie low returns...
In my mind this is just another liberal lie...do you see it... I read a lot of articles by msnbc and they are worst than the nazis spreading rumors and suttle lies in their pieces...they are for single payer healthcare...they want you to believe this and react this way...
Come on MarkWS! There are problems with our healthcare system that need to be addressed. I am not yet for a single payer system, but I do think we need to take steps to improve the system. That doesn't mean we should get rid of it. What does appall me and infuriate me to no end is how you here dare to say that MSNBC and liberals are worse than Nazis. That ignorant. It's an ignorance too many on both sides promote. How can this country thrive when such hatred exists in the political process - on both of its sides. You're a real dimwit if you truly think if everyone who does not see the world just as you do is a Nazi.
While profits are always on the mind of any company, pharma or otherwise, many shortages are driven by limited access to the active ingredients and the strict regulation of drug manufacture. For example, the company cannot simply boost its production to meet the demand, even if it could source main ingredients, it has to petition the FDA and then wait for approval before the lines can run...which takes months, sometimes years.
However, I agree with your statement that we (health care recipients) do not benefit from the current pay structure. HC in America has always been fee-for-service, meaning we pay for each pill we take and every procedure and office visit, regardless of the outcome. Instead, we should be on a pay-for-performance system, whereby prices are determined through cost-comparison studies and out-of-pocket spending depends on a measurable health improvement.
Unfortunately, much of the debate in America, and almost all of the proposed legislation concerns "who pays" and does not take into consideration "what" we are paying for. These threads are a perfect example of how politics and media want to divert your attention away from the real issue...namely the word CARE in health care.
A smart thinking firm who does not like that while there is a profit there is not a high enough profit to make them happy can easily make it someone elses fault by just manipulating the production line before the FDA (or whomever) shows up to inspect. Then....oh, no, we have to shutdown the line. So sorry. These people are the low of the low as humans.
Capitalism and many things, like heat, water and health care do not go well together.
I would advocate several steps toi correct these sorts of situations:
1) Make it a felony with a huge fine and prison time for anyone speculating in drugs, causing artificial shortages, or conspiring in any way to raise prices, diminish supplies, or cause patients to switch from generic to brand-name drugs. There are a lot of fly-by-nights that are doing exactly that. And insurance will not pay for the difference between the UCP (usual and customary price) and what the speculators charge.
2) Whenever a company creates a shortage such as this, any related patents should be considered abandoned and become the property of the taxpayer. Retaining a patent or production rights for a generic should depend on supplying the demand, not how much profit can be made. It would be fair to assume that any company which cannot manage its production lines better would not be trustworthy to manufacture a drug in the first place.
3) The government should be allowed to nationalize key drugs and make them available at cost. This would be especially useful in siutuations like HIV where the greater community benefits, vaccines where the benefits are so great that drug companies would be tempted to run up huge profits, drugs like the one in the article that are high impact, but typically low volume. The same nationalization might apply to things like high-end antibiotics used against drug-resistant TB where nationalization could be used to keep pill-happy physicians from prescribing these last-ditch drugs for the common cold.
4) The FDA approval process should be revamped: a) no drug should be approved unless it performs significantly better than a placebo. About 30% of all drugs approved by the FDA are actually no better than a sugar pill. b) no drug should be approved unless it is measurably better than existing drugs in the same family. This is one aspect of drug manufacturing that stretches manufacturing resources unnecessarily by simply having too many competing drugs. c) Fire every FDA employee who I) lack basic research skills --- physicians are not trained in research and II) have any financial interest in any for-profit medical industry or who refuse to disclose their finances, d) No clinical trial data should be allowed to be surpressed. It can be rolled up into further studies but NEVER be allowed to be withheld from the approval process as it is now. e) allow the FDA to fund, by grant, the transition from taxpayer-funded research to approval and marketing. Right now big pharma owns this process.
Those of you claiming that the FDA was involved in the shutdown are sorely misinformed. This is just another example of a corporation putting profits first, and people last. These cancer drugs can be made at a profit, just not as large a profit as most greedy MBA corporate pigs believe to be worth the effort. So, create a false production issue, shut down manufacturing, and watch as the drug prices soar to x80 the regular prices. But lo and behold, as soon as the shortage is at a critical juncture, suddenly the company begins producing medicine again!!! Also notice that not a single employee from this company has been laid off, or fired, even though production has been at a stand still since November.
Here is information directly from the FDA website regarding this issue...
http://www.fda.gov/Drugs/DrugSafety/ucm281782.htm
Duh, I believe if true free market forces were in effect in this case, there would be no shortage. I would say it is yet another example of uninted consequence of government meddling in the market. In this case, a generic drug was produced at a cost below that which the originator of the drug could make it. Obviously it wasn't profitable at that level so neither company produced the drug. Once supply began to fall, why didn't price begin to increase? Under normal market forces, with the supply as low as it is now, it should be profitable to make again, why not? Someone (government) is keeping the price artificially low, thus no one wants to make the drug. If there were no profit motive in medical drugs or otherwise, there just wouldn't be any, period. I see nothing wrong in that. The main reason we have the medical drugs and technology we have today is because someone realized they could make some money, AND make life better for someone else. Why is that wrong? Who are we to say what is a reasonable profit on anything? Furthermore, I can all but guarantee there is not a single drug made that is safe for every single person its prescribed to for its use, and who gets nailed, the drug maker. Even though they did the best they could to insure safety of the product, there is someone who will get an adverse reaction and sue the living daylights out of the manufacturer. Which brings be to my final point, this in regard to Obamacare, I have a feeling we'll see much, much more of this very thing under this monstrosity. Be Afraid, be very afraid.
You are misinformed 'hard'...
The prices of these cancer medicines have increased x80 since the production shutdown. It has zero to do with government meddling in the market or health care reform. If you did a bit more research on this issue you would understand what I'm talking about. There is a profit motive to produce these drugs, but it is not a very large profit, and that is the main problem. Some profit is not good enough when a corporation can manipulate the market to increase prices x80. There's nothing wrong with profit and business in general, but when taken to the most extreme scenario (like in this situation), it's bad for our healthcare.
Yet at the same time, you have to accept that profit margin aside, if the tax payer had to provide all the unaffordable or non profitable medication, we'd be a nation of poverty, which always brings with it in increase in disease. So, where to you draw the line? If a medication is expensive to produce who is going to bare the burden of that cost and to what cost of everyone else?
It is so old to see these people who seem to think they own the Nazi brand scream at anybody that dares to infer that things equally evil or even worse could exist. The whole world, to quote Churchill, was brought in 61 years ago and destroyed the Nazis. The few crazies who stooge around calling themselves Nazis today are, relatively speaking, a minor threat. Give it a rest. The Soviets killed far more if body count is a measure of evil.
People are so brain dead and brainwashed these days, they wouldn't believe there is a cure for cancer ---- even if they read a book about it, or someone told them.
When it comes to business, its always the money
That's what business is. BTW, most 401K's get a pretty good hit from the annuities in prescription drugs. I'm wondering if the hit was taken by your 401K if you'd be so generous.
This is how our system works. The other great thing about our system is that at any time you so desire you can start a 501C charitable organization, rally for donations, and make the medication yourself -- for the sake a charity - not profit. Lets see how long it would take before you went under as a business.
This is how "our" system works. Please note that it is not free market capitalism.
Say Thank You Mr. Obama
Nearly 4 years now, and still so many sore losers..
Last I checked, the democrats are still blaming Bush for things, so who are the real sore losers?
kinda hard not to after nearly a decade of power and we're barely 4 years past it...
What makes the Pharms any different than mexican cartels?
Now the question is...how many of our children must die at the hands of the fed and their drug cartels before we take back our lives?
It's always about the money for these corporate gaints, it is never about the lives the drugs save. IT's all for the money.
And your solution? Complaining never helps, we need constructive criticism.
If you want to take the power away from corporate giants, start your own research lab. Make your company about saving lives and don't worry about profits. Then you can make statements like that.
My proposal to solve the rising cost of healthcare...fund cost-comparative studies, migrate to pay-for-performance system, fund public outreach and educate the public about chronic disease management, fund genetic and personalized medical research. These will help HC costs plateau, and improve patient outcomes.
Having gone through Leukemia with our daughter in the 70's when nobody survived this disease, I can't imagine how terrible it would have been to have had to worry that the drug that was extending her life might have been pulled from her because our country couldn't get it's agencies together to manufacture the drugs. If children or anyone else dies beause of the lack of this drug everyone who caused it should be arrested and tried in court.
Thirty-five years ago (mid-70's) ALL was virtually a death sentence. Today, the vast majority of children diagnosed are actually CURED. And that's not my own spin on it; that's information from Dr. Michael J. Keating at the University of Texas M.D. Anderson Cancer Center in Houston. As a CLL survivor (Chronic Lymphocytic Leukemia), I have an opportunity to live out my life in remission, or with new treatments coming down the pipeline all the time, at least a chance to go back into remission if, or when, my disease presents itself again. However, if it boils down to the needed drugs being in short supply because they aren't making the big bucks for the pharmaceutical manufacturers, it begs the question:
What PRICE do we put on human life versus a drug? This entire situation sickens me.
And at what cost would it come to our country to intercede and pay for all unprofitable, but life saving drugs for all?
There is no warm fuzzy feeling fantasy ending to this situation. Its bad on both sides. Again, and as someone else posted, start your own not for profit lab and see how long you can go without making a profit on products that I am sure are very expensive to produce.
Either people die or our County lives in poverty. Kinda sucks either way. I wonder how many people are willing to give up the portion of the 401K that reeks the benefits of the for profit drug industry?
All the medication shortages are because the drugs are not profitable to make
That was the last line in the story and says it all for me. It has never been about the consumer or their families. It has always been about the pharmacutical companies trying to squeeze a quarter out of every nickle.
I am not a liberal. I am definitely not a nazi or a socialist. I believe in capitalism. I don't believe Mr. Obama had anything to do with my situation. I do have cancer. My doctor's drug of choice for my chemotherapy (Taxol) was not available. The explanation was that no pharmaceutical company was interested in manufacturing this drug because there was not much profit to be made from it, even though it is a life-saving cancer treatment. The alternative choice for chemo caused me life-threatening side effects and landed me in hospital for a few days. We had to stop any further chemo treatment. The bottom line is that I did not get optimal treatment. In my personal experience, it seems that capitalism and healthcare do not play well together. There must be a better way. The power to give and take life should not be left in the hands of pharma execs making decisions based solely on profitability.
I'm so sorry for what you have gone thorough and I agree this is a very heart breaking situation. But even if it were in the hands of the Gov't cost cannot be ignored. We'd be a bankrupted nation - we're already on our way there because of so many entitlements now (including the corporate welfare).
No matter what the topic is, when you have more money being pulled out of the communal bank then going in, eventually you will be completely broke.
Our first son was in one of the first studies using MTX as a protocol. We were in the Army and he was being helped by Fitzimmons Medical Center which was working with Denver Children's at the time. Methotrexate has made it possible for children and their families to hold on to hope of a better tomorrow. Whatever the issue, I pray the supply can maintain itself. I don't care of the politics-just fix the damn problem!!!!!!!
I'm sorry.....just like the gas "shortage" of several years ago, this is just a scam to raise prices again!
On the box of a med I am currently on it says Manufactored FOR >>>>>, then it says Manufactured IN INDIA!!! I believe very little I am told anymore......
The large pharmaceutical companies have learned by example. The example set by the oil companies.
There is no excuse for this to happen!!! Shame on those who have allowed it to happen!!!
Am I the only one who read this sentence in the article?
The product was produced before the troubled firm voluntarily shut down its operations in November because of manufacturing and quality problems identified during FDA inspections
The shortages started after the shutdown.
No your not the only one, although i was beginning to think the same thing. Did anyone else read the article, where this was stated then how it proceeded to state how several other companies are trying to produce more of the product to help deal with this, or did you all just read the title and the last two lines?
Yes I did. The company only had to let a few things slide and voila..... FDA identifies problems.....the company voluntarily shut down its operations...... they were not forced to and neither did they care to fix them. The operative word always seems to come down to "care." Capitalism does not Care. Profits are not a caring business.
I have been working in healthcare for 15 years and I have never seen so many medication shortages. There are a plethora of other medication shortages out there as we speak. For those that say profits have nothing to do with this; I ask. Why is it that only generic (Cheap) medications are the ones in shortage?
Another example of "Hope" and "Change you can believe in..." If you think drugs and healthcare are expensive now Imagine what it will be when it is "FREE" But cannot be purchased or even found at any cost. Would you rather pay a fortune for a pill to cure what afflicts you or be told there was no pill? This is a preview of what awaits us when the government takes over... The drug is manufactured without preservatives (because the preservatives can be toxic) which to me means it has an extremely limited shelf life. Being produced in limited runs means that any bad run can cause a shortage. I guess the Evil Greedy Corporations should have sent the defective meds out anyway and killed some children. Remember that quality control issues with the first Salk Vaccine for Polio actually killed 10 people and actually infected over 300 with Polio. Without profit there would be little incentive to research and produce such miracles. Its a hard fact of life. If anyone thinks they can make lifesaving meds and vaccines better than the current crop then go for it, You will only have to fight the actual disease, cost of years of research and the US government. I sincerely hope everyone will get their meds in time.
For all those who stated that this was a scheme to raise profits 80x over or whatever it was, for shame. Quality issues resolved, production back. Period.
My fault. Production NOT back, releasing product with FDA approval from before shutdown, since FDA is signing off that this product meets spec. Still not a $$ grab, regardless.
just another white kid to grow and be a bigot, let him die, the world will be better without him.
My question for the companies that manufacture these drugs is. How many diet pills do the sell every year?
Like many here I believe that this is not as much about the FDA shutting down one line due to safety violation so much as it is about the profit margin of the drug.
I know a lot of the right wing wack jobs here are going to scream socialism for suggesting this, but perhaps it is time to add a manufacturing wing to the FDA to make drugs that pharmacudical companies do not find profitable enough to manufacture in sufficient quantities.
AGREED!
Like the mob hit man says to his best friend just before he kills him, "Sorry, it's just business". That's how capitalism works. If there's no money in a product, big pharma generally doesn't make medications out of the goodness of their heart (because they don't have one!). This is going to happen more and more, ESPECIALLY after the Health Care law if fully implemented in 2014.
its going to happen more regardless of any healthcare law that keeps the HC power in private industry. They have already learned how to raise their profits... just cause a shortage.
make less charge more
and dont worry about the suffering kids
typical drug producer tacticks
probably payback for generic brands
sadsadsad
My mother has rheumatoid arthritis and she takes methotrexate. She has an endless supply of it. I have never seen her having a problem getting her script filled and she has taken it for 15 years or more. I don't understand the problem of getting it to those kids, when she can have as much as she wants. It's a disgrace.
It's relatively cheap for her insurance, too. I bet they are gouging the hell out of it for the families of those kids with cancer.
The tablets your mom and I both take for RA contain preservatives, and is not the same as the non-preservative injection form that these young cancer patients require. Not sure exactly how different the availability/supply of each is currently, but I'll be asking my rheumatologist on my next visit.
Keep in mind those with money and political connections will be the ones to get what is available. Remember the flu vaccine shortage? Those who had money and political connections got what flu vaccine that was available - the rest of us were told to WASH OUR HANDS.
Where are those Republican Congressmen we all voted for? Why have they not dealt with this issue?
How about less focus on gay marriage - and more focus - on saving the lives of American KIDS.
Like the mob hit man says to his best friend just before he kills him, "Sorry, it's just business". That's how capitalism works.
And it is the job of elected politicians to regulate how capitalism works. Where are those Republican Politicians we all voted for to deal with these issues?
Many, if not all of those commenting need a refresher in reading comprehension. This never was about profit margins, no matter what ill-informed, but obviously frustrated mother had to say. There are only four companies that manufacture MTX, and one of them stopped production, voluntarily. Ergo, now the country is down to 75% of supply, assuming that all 4 companies share manufacturing capabilities (which I don't believe is fact). This has been a four month old problem, yet just now are people, who are left will few alternatives, are becoming aware of it.
If Ben Venue had not stopped production, peoples lives may very well been in danger. That, compounded with the threat of class-action lawsuits and FDA mandated fines would render ANY manufacturer helpless. The resultant three companies cannot simply spit more pills out. They have to be tested, with extensive QC, even IF they can get their hands on the raw ingredients, which may or may not be available. While an obviously frustrating situation, this isn't one of those "OMG its the Republicans/Democrats!!!! AHHH I hate Big Pharma/FDA!!!!".
Your speculative logic is overlooking the elephant in the room - people's lives really are in danger now because of this stoppage! There is no 'if' or 'may very well' regarding this issue, unless of course you're referring to the logic of the execs at BV when they decided to shut down production.
Maybe it is you that needs a refresher in reading comprehension, or at least dig a little deeper for the facts. IN FACT, the production stoppage was self-imposed by BV, and then BV notified the FDA afterwards. Of course, the FDA confirmed BV's findings. But, again, it was BV that claimed to have discovered the 'safety' issues in the first place. We all know that corporations NEVER engage in market manipulation to increase profits (i'm looking at you Enron!). This is all just an unfortunate circumstance.....right? BULLSHEEIT!
http://www.fda.gov/Drugs/DrugSafety/ucm281782.htm
Speculative logic? Sounds like you are the one speculating. You seem to imply that BV may have falsified reports into manufacturing safety. That makes a lot of sense! I'm sure you would be one of the first to stand up and howl at the fact that a company was making a potentially dangerous pharmaceutical had they continued (a VERY profitable manufacturing line at that)!
The elephant has been in the room for a looong time, btw. So tell me which scenario makes more sense:
1) BV stopped production b/c of an unforseen QC problem, in an effort to comply with safety policies.
OR
2) BV is pure evil, and fabricated a story of safety concerns (which have been independently validated) b/c they wanted to stop manufacturing ALL of their product lines, which costs exponentially more than merely stopping one drug, all in the effort to intentionally put peoples lives in danger. You also forget that BV is under no obligation to produce this drug, but again, instead of handing the process (and money) to competitors, they risk losing ALL of their supply and business by self-inflecting this cyanide pill that stops ALL sources of revenue.
Oh, and " market manipulation to increase profits" kind of did it for me. Why would a company LOSE ALL PROFITS in the attempt to manipulate the market? Please, do explain!
Hey you're the one linking to the facts, from the FDA, that directly refute you claims. But why let reason and logic influence you? I'd go with Occam on this one...but please, by all means keep your theories coming. They are entertaining if nothing else.