Freeken drug companies

[KC2IFR]

Seems that some drug companies are holding back on making a certain cancer drug that helps kids because its a low profit product.......

Someone should shoot these ass holes.............

Bill :irked:

[WX7P]

Seems that some drug companies are holding back on making a certain cancer drug that helps kids because its a low profit product.......

Someone should shoot these ass holes.............

Bill :irked:

Need a little more information....

[KC2IFR]

The story is on the news.........it started last nite............the latest is that the government is working with the companies to manufacture the drug........

[KC2IFR]

More info........
http://www.washingtonpost.com/business/childrens-cancer-drug-shortage-should-ease-fda-says-but-doctors-parents-worry-itll-recur/2012/02/14/gIQAZPDRER_story.html

[KC2UGV]

Meh, who needs the children.

What a play for some more corporate welfare...

[KG4CGC]

Barack 2012
Michelle 2016

[kb2vxa]

Just another in your face example of "Hurry up and DIE already!" (}=O)

[N2RJ]

First off let me start off by saying that I read the entire article, twice.

And from what I see, the drug companies ARE willing to boost production, but they need FDA approval to do that.

In other words, it's not profit motive. It's the Government and the regulatory approval process that is slowing things down.

I am fine with regulation, as long as the Government can move quickly. Clearly it can't in this case.

Of course legislators are playing the populist tune and bringing up words that stir emotions, such as "price gouging" because they know that brings votes and hides their own incompetence.

[N2RJ]

Seems that some drug companies are holding back on making a certain cancer drug that helps kids because its a low profit product.......


Cite please.

I call BS on this one. The bolded part.

Cancer drugs are freakin' expensive. Drugs in general are expensive. They are hardly a low profit product.

[KC2IFR]

Cite please.

I call BS on this one. The bolded part.

Cancer drugs are freakin' expensive. Drugs in general are expensive. They are hardly a low profit product.


U must work for a drug company...............u did not read the whole story............

[WX7P]

First off let me start off by saying that I read the entire article, twice.

And from what I see, the drug companies ARE willing to boost production, but they need FDA approval to do that.

In other words, it's not profit motive. It's the Government and the regulatory approval process that is slowing things down.

I am fine with regulation, as long as the Government can move quickly. Clearly it can't in this case.

Of course legislators are playing the populist tune and bringing up words that stir emotions, such as "price gouging" because they know that brings votes and hides their own incompetence.

Are you sure we have read the same article? I don't know how you got to the problem being the government from this:



“We understand from all three companies that they will be starting to ship by the end of the month,” Jensen told The Associated Press. She noted that federal regulations bar the FDA from discussing plans of specific companies, as that’s considered proprietary information.
The three manufacturers of the drug — Mylan Inc., Hospira Inc. and Sandoz Inc. — weren’t specific about how they plan to resolve the shortage of the cancer medicine:—Mylan says it’s working on increasing manufacturing capacity, which includes getting approval for that from the FDA. The company has an emergency supply of small vials of methotrexate, and plans to ship larger vials at the end of the month.—Hospira temporarily boosted production to address the shortage issue, but then ran out of the active ingredient. It is still producing some of the drug, but is trying to get more of the active ingredient.—Sandoz is aiming to ship some of the drug in late February. The company did not provide any details.
APP Pharmaceuticals LLC, which makes a form of methotrexate with preservative, said it is working with the FDA to determine whether it could get approval for a preservative-free formula. The preservative-free version is needed by both children and adults when methotrexate is given in very high doses intravenously or by injection in spinal fluid. Preservatives in the drug can cause potentially fatal respiratory and organ damage or, when put into spinal fluid, paralysis.

What I see here is the production stopped in one factory. You're making a huge leap blaming the government for this situation. It looks like they are trying hard to work through it. If you're going to jump on the screw the government bandwagon, you could use a far better example than this one.

As for the OP's assertion regarding profit taking, I think he's referring to this:



Meanwhile, several members of Congress have been introducing bills aimed at addressing various causes for the shortage and price gouging that’s been reported by marketers outside hospitals’ normal distribution channel.

It is what it is if there is price gouging going on. If that's the case, it should be addressed. Don't understand why that's an issue for you. As for the drug companies themselves, I don't see a conspiracy based on what the OP posted. It's a problem that needs to be addressed, not assigned to the "evil big pharma" or "evil government" junkheap.

[KC2UGV]

First off let me start off by saying that I read the entire article, twice.

And from what I see, the drug companies ARE willing to boost production, but they need FDA approval to do that.

In other words, it's not profit motive. It's the Government and the regulatory approval process that is slowing things down.

I am fine with regulation, as long as the Government can move quickly. Clearly it can't in this case.

Of course legislators are playing the populist tune and bringing up words that stir emotions, such as "price gouging" because they know that brings votes and hides their own incompetence.

The shortage was caused by a producer shutting down a production line... To shrink supply, and drive up demand; which, if you believe in the free market, should realize that it will drive up price as far as the producer wants to due to the inelastic demand curve of medical supplies.

[KG4CGC]

There is some truth in what Ryan said but the way I see it, it translates to ''nothing happens until everyone gets their bribe.''
Bribes, favors, yada yada etc etc.

[NA4BH]

If this discussion includes one particular drug, Methotrexate, that drug has been available for over 30+ years. It should be in generic form by now and not controlled by one company.

As for post #10, yes I do.

ETA: the money spent for drugs pays the research and development/testing (years of it) that the drug companies have to pay for on the front end. They will make a profit 10X/100X/1000X, what the market will pay for.

[suddenseer]

First off let me start off by saying that I read the entire article, twice.

And from what I see, the drug companies ARE willing to boost production, but they need FDA approval to do that.

In other words, it's not profit motive. It's the Government and the regulatory approval process that is slowing things down.

I am fine with regulation, as long as the Government can move quickly. Clearly it can't in this case.

Of course legislators are playing the populist tune and bringing up words that stir emotions, such as "price gouging" because they know that brings votes and hides their own incompetence.We need to balance the need for safe, and effective with recreating the wheel. Some of the EU states, and even Mexico, and Canada has apparently figured it out. BTW...it seems a crime to me that the USA is apparently the only country that allows drugs in the form of "food" to be added to our food. Yes, I am referring to HFC. I think it is a drug. I may be wrong, but my life has improved after getting the crap out of my home.

I remember some of the gay population (which I belong to) made much noise to the FDA to speed up the 7-10 year process of drug approval (which they did) for HIV positive patients. Apparently children cannot make enough noise to get their attention.

[KC2UGV]

Oddly enough, I'm betting there's no issue exporting these drugs to Canada... And, I'm betting Canada has no supply shortage. Whouda thunk it?

[suddenseer]

The shortage was caused by a producer shutting down a production line... To shrink supply, and drive up demand; which, if you believe in the free market, should realize that it will drive up price as far as the producer wants to due to the inelastic demand curve of medical supplies.Harley Davidson tried that as well, it bit them in the ass.

[NA4BH]

Other countries don't have the "strict" standards that the USA does. Granted the rules are very tough here and the same drugs are sent to Canada, less rules. Mexico is different. Drugs available there look just like the real thing, but are not always what they seem (people die).

Strict standards = greasing palms or whatever

[suddenseer]

If this discussion includes one particular drug, Methotrexate, that drug has been available for over 30+ years. It should be in generic form by now and not controlled by one company.

As for post #10, yes I do.

ETA: the money spent for drugs pays the research and development/testing (years of it) that the drug companies have to pay for on the front end. They will make a profit 10X/100X/1000X, what the market will pay for.The cost of drugs skyrocketed after the ban on tv/radio ads was dropped. The USA was recently joined by New Zealand as the only 2 countries on Earth that allowed broadcasting drug ads. After the price for brand name drugs jumped over 300% IIRC, NZ had better sense than us, and reset the ban. The last time I checked, we are still the only nation on the planet that is stupid enough to allow broadcast ads for brand name prescription drugs. I am not suggesting that this is the only reason for outrageous prices, but it is a factor hitherto not mentioned. (Albi lingo).

[NA4BH]

You are correct. We go to the doctor and tell him what we want. It's just like the old cigarette commercials, brainwash people into thinking you have the best cigarette, anti depressant, male performance drug out there. People tell the doctor who had the best commercial. Why do you think GE and Seimens have medical commercials on TV? You have no choice in what scanner the facility you go to has, but when you see the names you are comforted. And they don't have the best equipment out there. But you are told they do.

[VE7DCW]

Oddly enough, I'm betting there's no issue exporting these drugs to Canada... And, I'm betting Canada has no supply shortage. Whouda thunk it?

Nope no supply shortages on any drugs ....... including the illegal ones :mrgreen:

...... and to boot the British Columbia provincial government's fair Pharmacare program will cover my drug costs after I have reached a $200 deductible at the pharmacy....... covers pretty well all the pharmaceauticals I could be using ..... "FAJIIIITTA" :agree:

[N2RJ]

Nope no supply shortages on any drugs ....... including the illegal ones :mrgreen:

...... and to boot the British Columbia provincial government's fair Pharmacare program will cover my drug costs after I have reached a $200 deductible at the pharmacy....... covers pretty well all the pharmaceauticals I could be using ..... "FAJIIIITTA" :agree:

Even my job's high deductible option healthcare plan covers most of the drug costs.

My wife's plan has a copay of $5 only. So I stay on her insurance. :)

When I see how much some of those drugs cost, I am thankful.

[N2RJ]

U must work for a drug company...............u did not read the whole story............

U must be new here...........

I quit working for big pharma almost 10 years ago. I hated working for that company.

[N2RJ]

Are you sure we have read the same article? I don't know how you got to the problem being the government from this:

Quoting the whole thing in context makes the picture clearer.

Clearly there is some regulatory hurdle that is at the very least slowing things down. (pertinent parts bolded):



The three manufacturers of the drug — Mylan Inc., Hospira Inc. and Sandoz Inc. — weren’t specific about how they plan to resolve the shortage of the cancer medicine:

—Mylan says it’s working on increasing manufacturing capacity, which includes getting approval for that from the FDA. The company has an emergency supply of small vials of methotrexate, and plans to ship larger vials at the end of the month.

—Hospira temporarily boosted production to address the shortage issue, but then ran out of the active ingredient. It is still producing some of the drug, but is trying to get more of the active ingredient.

—Sandoz is aiming to ship some of the drug in late February. The company did not provide any details.

APP Pharmaceuticals LLC, which makes a form of methotrexate with preservative, said it is working with the FDA to determine whether it could get approval for a preservative-free formula. The preservative-free version is needed by both children and adults when methotrexate is given in very high doses intravenously or by injection in spinal fluid. Preservatives in the drug can cause potentially fatal respiratory and organ damage or, when put into spinal fluid, paralysis.

Dr. Peter Adamson, chairman of the Children’s Oncology Group, a network of 200-plus North American hospitals treating children with cancer, said FDA officials “have been reassuring in discussions that this is not going to be a prolonged shortage.”

Still, he said: “Until the drug is actually delivered, we can’t be sure.”

Until late last year, five drugmakers in the U.S. manufactured the generic injected cancer medicine methotrexate, which is crucial for treating children and adults with ALL as well as children with other, less-common cancers.

So it is readily apparent here that the ball is in the FDA's (Government's) court, for much of this shortage. To be fair, one drug company did have a shortage of an ingredient, but the major issue here seems to be regulatory approval for manufacturing the drug without a preservative.

I used to work for the company that made the little blue pills years ago, so I have some insight. The drug companies have to invest a ton of money to comply with regulations. Information technology systems has such things as tracking sales, recording clinical trials and providing data to the FDA and other regulatory agencies (worldwide) were par for the course. There can't be any slipups here because you are dealing with medicine and life, and you are dealing with a heavily regulated industry.

The companies ARE willing to do what it takes. There's really no reason to sell less of a product that they can get a high price for anyway. The FDA is the one who they are waiting on, and the FDA has even gone as far as to promise that "the shortage won't last too long" meaning essentially that they are at the very least taking partial responsibility.

As for the reason for the shutdown in the first place:



Four of those companies made a preservative-free version. So, when one of the biggest makers of the preservative-free methotrexate, Ben Venue Laboratories Inc., recently shut down its four factories in Bedford, Ohio, possibly for a year, due to serious quality problems, the on-again, off-again methotrexate shortage that began in late 2008 quickly turned into a crisis. That’s because the other companies cannot quickly pick up the slack.



What I see here is the production stopped in one factory. You're making a huge leap blaming the government for this situation. It looks like they are trying hard to work through it. If you're going to jump on the screw the government bandwagon, you could use a far better example than this one.

Sure. While other jurisdictions such as Great Britain or the EU are approving life saving medicines, the FDA is blocking access to life saving medicines.

In the EU the regulators basically compete with each other to approve drugs for sale. Once one regulator approves, they all have to reciprocate. In the USA, the FDA is basically a monopoly that takes its sweet time. We have no alternatives and that is blocking access to life saving medicines.

Clearly we are doing something wrong, and breaking the monopoly of the FDA would be a good start.

[N8YX]

U must be new here...........



Relatively speaking, you both are. Remember that you've been away for some time. ;)

[KK4AMI]

I think you are all partially right.

http://www.fiercepharma.com/press_releases/ben-venue-laboratories-inc-temporarily-suspends-manufacturing-and-distribut

Our Bureaucracy kicked us in the ass again. The Government strictly regulates drug making machines and Ben-venue laboratories tried to squeeze every last dime out of their old equipment. The company decided to voluntarily shutdown the factory when it was time to rebuild it. Not smart. Methotrexate is a generic drug now. It's not just a cancer drug, its also used for a number of other ailments from Ectopic pregnancies to rheumatoid arthritis. I think this was a case of piss poor regulatory oversight and piss poor company management.

[KC2UGV]

Harley Davidson tried that as well, it bit them in the ass.

Motorcycles do not have an inelastic demand curve. Medical supplies do.


Other countries don't have the "strict" standards that the USA does. Granted the rules are very tough here and the same drugs are sent to Canada, less rules. Mexico is different. Drugs available there look just like the real thing, but are not always what they seem (people die).

Strict standards = greasing palms or whatever

Canada's standards are just as high. The difference? The government is able to negotiate prices.


I think you are all partially right.

http://www.fiercepharma.com/press_releases/ben-venue-laboratories-inc-temporarily-suspends-manufacturing-and-distribut

Our Bureaucracy kicked us in the ass again. The Government strictly regulates drug making machines and Ben-venue laboratories tried to squeeze every last dime out of their old equipment. The company decided to voluntarily shutdown the factory when it was time to rebuild it. Not smart. Methotrexate is a generic drug now. It's not just a cancer drug, its also used for a number of other ailments from Ectopic pregnancies to rheumatoid arthritis. I think this was a case of piss poor regulatory oversight and piss poor company management.

This has nothing to do with the government, and has everything to do with a for-profit company shrinking demand on a product with an inelastic demand curve; in order to drive up profits.

[KK4AMI]

"This has nothing to do with the government, and has everything to do with a for-profit company shrinking demand on a product with an inelastic demand curve; in order to drive up profits.[/QUOTE]"

Wrong Again Grasshopper!

"According to health officials, the shortage comes after Ohio based manufacturer Bedford/Ben Venue stopped production of the drug due to quality issues pointed out by the FDA. [8] (http://www.wdtn.com/dpp/news/kids-cancer-drug-shortage-alarms-dcmc) In October, President Obama signed an executive order giving the FDA greater authority to manage shortages as well as counter price-gouging. The FDA has headed off 114 shortages this way since Oct. 31, Burgess says. Sen. Amy Klobuchar, D-Minn., has introduced legislation to require manufacturers to report shortfalls of all medications to the FDA. Today, drugmakers are required to notify the FDA of shortages only in scarce drugs for which they're the only supplier. [3] (http://yourlife.usatoday.com/health/story/2012-02-14/FDA-Shortage-of-kids-cancer-drug-can-be-averted/53097852/1) "

Govt run anything drops the ball again! The FDA could have stoked the other companies before shutting down Ben Venue!

[KC2UGV]

Wrong Again Grasshopper!

"According to health officials, the shortage comes after Ohio based manufacturer Bedford/Ben Venue stopped production of the drug due to quality issues pointed out by the FDA. [8] (http://www.wdtn.com/dpp/news/kids-cancer-drug-shortage-alarms-dcmc) In October, President Obama signed an executive order giving the FDA greater authority to manage shortages as well as counter price-gouging. The FDA has headed off 114 shortages this way since Oct. 31, Burgess says. Sen. Amy Klobuchar, D-Minn., has introduced legislation to require manufacturers to report shortfalls of all medications to the FDA. Today, drugmakers are required to notify the FDA of shortages only in scarce drugs for which they're the only supplier. [3] (http://yourlife.usatoday.com/health/story/2012-02-14/FDA-Shortage-of-kids-cancer-drug-can-be-averted/53097852/1) "

Govt run anything drops the ball again! The FDA could have stoked the other companies before shutting down Ben Venue!

So, a company fucks up the drug, and somehow, this is the government's fault?

But yet, Canada, whose requirements are just as stringent, has no shortage?

[K7SGJ]

So, a company fucks up the drug, and somehow, this is the government's fault?

But yet, Canada, whose requirements are just as stringent, has no shortage?

And don't forget about the part where seniors (and others) go to Canada to get the same Rx drugs as those in the US, but a whole lot less expensive. Speaks volumes about the US health care ripoff.

[KG4CGC]

Can they still go to Canada for that? I thought they put they kibosh on that back in 2005. Recently they ran yet another story about going to Mexico to get prescriptions written and filled on the spot. Those are perfectly legitimate in Mexico too and apparently legitimate enough to get you across the border home should the question arise upon your return.

[KK4AMI]

So, a company fucks up the drug, and somehow, this is the government's fault?

But yet, Canada, whose requirements are just as stringent, has no shortage?

Strike Two Grasshopper! Look up Canadian Drug Shortages on Google

http://www.canadadrugshortage.com/

[KC2UGV]

Can they still go to Canada for that? I thought they put they kibosh on that back in 2005. Recently they ran yet another story about going to Mexico to get prescriptions written and filled on the spot. Those are perfectly legitimate in Mexico too and apparently legitimate enough to get you across the border home should the question arise upon your return.

You still can, I believe. After 2005, I know (Might have changed since). I know between '06 and '07 I was going to Canada for medical procedures. Even without insurance, it was cheaper there than here (My insurance wasn't accepted in Canada).


Strike Two Grasshopper! Look up Canadian Drug Shortages on Google

http://www.canadadrugshortage.com/


"
nor does it question the possibility of causes originating in profit-motive"

So, again, how is this the government's fault?