Shortage of life saving drugs

[billc]

this is an article from Pajamasmedia.com about an approaching shortage of life saving drugs, including chemotherapy supplies.

http://pajamasmedia.com/blog/americas-other-drug-problem/

During the past year, medical professionals have received alarming reports about critical shortages of important drugs. These drugs aren’t the common over-the-counter medications that consumers purchase in their local drugstores. Rather, the shortages are in various injectable drugs typically administered to seriously ill patients in hospitals.

FDA regulations impose an enormous financial burden on drug companies. In a detailed critique of the FDA, pharmaceutical industry writer Stella Daily Zawistowski observes that the FDA drug approval process currently costs companies approximately $800 million “from the time a molecule is discovered in the laboratory through animal trials and multiple stages of trials with human subjects.” Furthermore, the 20-year patent clock starts “ticking” once the drug is discovered, even though the drug approval process often takes more than 10 years. Hence, a company that spent enormous sums developing a new drug might enjoy less than half of that theoretical 20-year patent life to recover its initial investment before other companies start selling chemically identical cheaper “generic” versions.

The FDA drug approval process is so onerous that many experts believe that certain drugs currently in widespread use would never have been approved by today’s FDA — including penicillin, aspirin, and acetaminophen (Tylenol). In 2010, the FDA approved a mere 21 drugs — what the Wall Street Journal calls “a relatively modest figure” and a continuation of the “drought in recent years.”

Melly Alazraki of Daily Finance reports that the shortages include “vital medications such as chemotherapy, antibiotics, analgesics (painkillers), anesthetics and more.” ABC News details how Minnesota cancer patient Mark McKee was suddenly told at a scheduled chemotherapy session that the hospital did not have enough of the critical medication doxorubicin for his prescribed treatment. Despite the fact that his tumor had grown recently, his doctors told him he had to settle for a significantly reduced dose and hope that “something may be better than nothing.”

 

[billc]

The article also believes that abolishing the FDA and letting private monitoring companies like the Underwriters Laboratory monitor drug safety, would speed up the creation of new drugs and get safer drugs on the market faster.

"
There’s no reason to think that a government agency would be better at picking pharmaceutical winners and losers than a private company that has its own money on the line and is motivated to earn a profit. Rather than creating yet another bureaucracy to “encourage” the development of drugs the government deems worthy, the government should consider a radical alternative. It should reduce the regulatory burdens on the pharmaceutical industry by phasing out — and eventually abolishing — the FDA.

Private ratings agencies already work superbly in other industries. The private Underwriters Laboratories (UL) tests and approves numerous products ranging from hair dryers to Christmas lights to bulletproof glass. Manufacturers gladly pay for their testing and certification because many retailers won’t stock products without the UL seal of approval.
Similarly, the Snell Memorial Foundation (SMF) performs similar testing and certification of safety helmets. As John Graham of the Pacific Research Institute writes [pdf]:

Many people engaged in activities for which helmets are an important safety feature, such as mountain biking, value the SMF certification, and this motivates manufacturers to submit their helmets for testing at their own cost although there is no legal requirement to do so.
​

The SMF limits itself to the business of researching and testing the effectiveness of helmets. It does not advocate for mandatory helmet laws and has never lobbied on any pertinent legislation.

 

[Bill Mattocks]

There is also a shortage of life-ending drugs:

http://www.telegraph.co.uk/news/wor...ethal-injection-drug-halts-US-executions.html

 

[billc]

To help pay for the prison system you could put one dose of lethal drugs in a syringe for every two convicted killers. Put them in a room, whoever manages to inject the other guy first gets a life sentence instead of the death penalty. Put it on Pay per view and you have a cash cow on your hands.

 

[granfire]

To help pay for the prison system you could put one dose of lethal drugs in a syringe for every two convicted killers. Put them in a room, whoever manages to inject the other guy first gets a life sentence instead of the death penalty. Put it on Pay per view and you have a cash cow on your hands.

So you are against make-believe violence when targeted against 'The Right' but all pro real death and blood shed when convinient.

 

[CanuckMA]

There’s no reason to think that a government agency would be better at picking pharmaceutical winners and losers than a private company that has its own money on the line and is motivated to earn a profit. Rather than creating yet another bureaucracy to “encourage” the development of drugs the government deems worthy, the government should consider a radical alternative. It should reduce the regulatory burdens on the pharmaceutical industry by phasing out — and eventually abolishing — the FDA.

Because drug companies would never simply weigh the potential cost of lawsuits against profit and go to market based on that.

And if you think that private testing companies like UL and CSA in Canada are the alternatives, you have no clue what you are talking about. Those private companies get away with charging enormous amunt of money for testing and approval.

Let me put it this way. I know a few people who design and build ice hockey goaltending helmets. They use the exact same materials and processes for all sizes. Howver, to gain approval, each helmet size needs to be tested, ant a cost for each size.

I can see UL requiring the testing of a medication for both 50mg and 100mg pills.

 

[Carol]

Because drug companies would never simply weigh the potential cost of lawsuits against profit and go to market based on that.

And if you think that private testing companies like UL and CSA in Canada are the alternatives, you have no clue what you are talking about. Those private companies get away with charging enormous amunt of money for testing and approval.

Let me put it this way. I know a few people who design and build ice hockey goaltending helmets. They use the exact same materials and processes for all sizes. Howver, to gain approval, each helmet size needs to be tested, ant a cost for each size.

I can see UL requiring the testing of a medication for both 50mg and 100mg pills.

What is a lawsuit to a drug company I wonder? A pharma company that I'm familiar with was hit with a big lawsuit by the FDA for this that and the other. They paid up, and as a result the cost of a medication that I take is now 3 times more expensive than it was 6 years ago (the last time I was worried about going without insurance)...and it was bloody expensive to begin with. I know people that take home less in a month than what my insurance company is paying for a 30 day supply of this med.

The false economy that has been created with our health care system isn't going to be fixed by Obama-Care, nor is it going to be fixed by getting rid of the FDA. The issues are too systemic.

 

[billc]

Remember, as a conservative I do believe there are times for a very liberal use of violence. Those times would be against bad guys trying to hurt good people. Also as a conservative, I believe that making inmates fight each other for cable t.v. pay per view events would fall under the "cruel and unusual" clause of the constitution. Having two murderers fight each other as the thought behind a joke is a lot less wierd than when lefties fantasize about killing conservatives because a young conservative girl believes in not having sex before marriage, one of the people almost killed in the movie "the last supper." There is an eensy, weensy, bit of a difference there grandma.

 

[billc]

It's called captalism, "if you are good at something never do it for free" and if a company can certify to a great extent that a drug is safe to use, and they can speed up the process of getting that drug to market they should be payed well. I would rather have someone in a private company do this than a government worker who has no risk involved, especially when they screw up. U.L. seems to get the job done. So what if a company charges for different size hockey helmets. I believe the physics involved in a different sized helmet probably warrents the seperate inspections anyway. If the company also has a good reputation, the price is probably worth it to get certified by them. If you don't think it does, start your own company to certify product safety. That is also the miracle of capitalism. If you think you know how to do something better, you can give it a go. then you can get rich.

 

[billc]

Law suit abuse is a big factor in rising medical costs all around. Something people who sue frivolously don't realize.

 

[granfire]

Remember, as a conservative I do believe there are times for a very liberal use of violence. Those times would be against bad guys trying to hurt good people. Also as a conservative, I believe that making inmates fight each other for cable t.v. pay per view events would fall under the "cruel and unusual" clause of the constitution. Having two murderers fight each other as the thought behind a joke is a lot less wierd than when lefties fantasize about killing conservatives because a young conservative girl believes in not having sex before marriage, one of the people almost killed in the movie "the last supper." There is an eensy, weensy, bit of a difference there grandma.

So you are for violence when it suits your fancy....sounds doggon liberal to me.

oh, one is a movie, make believe, the other is your proposal of real death...hmmmm

 

[CanuckMA]

UL/CSA is a terrible model because the are private monopolies.

The easiest way to both speed up and reduce cost of drug approval is for countries like the US, Canada, the EU to get together and agree on standards. The concept that a drug has to be approved in all those jurisdictions is just plain ridiculous.

 

[WC_lun]

Law suit abuse is a big factor in rising medical costs all around. Something people who sue frivolously don't realize.

A big factor in rising medical cost? No. Its not. While it is a factor, it is not a large factor by any means.

 

[Nomad]

In many ways, I think the FDA's constantly rising bars to new medications are a reflection of the public distrust in the pharmaceutical industry and the backlash and lawsuits that inevitably ensue if a drug makes it to market and is later recalled... even if the recall is related to side effects or statistical occurrences that would have been impossible to predict from the already fairly long, large scale clinical trials required to consider bringing a drug to market.

In a minor correction to the OP, the cost of $800 million is one I saw many years ago; the figure is now well over $1 billion on average. It is certainly true that many drugs that have been used relatively safely for decades would not be approved under current restrictions.

With the FDA (and other National organizations throughout the world) requiring longer trials, (often looking for quite small increased risk of cardiac effects, for instance), perhaps the simplest (partial) solution would be to either increase the patent length past 20 years, or change when the clock "starts ticking" to a later point in development. Not an easy task, but at least theoretically possible.