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Why Deny Life Saving Drugs to Children?


W_L

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http://www.cnn.com/2014/03/10/health/cohen-josh/index.html?hpt=hp_c2

 

This is one of those really sad cases that on the surface, the evil company is holding drugs from dying kids to use, but on a deeper level, it is an issue with how our economic, social, and regulatory model is structured in a way that makes it a no-win scenario.

 

If this is a problem, I would also say Americans are not alone in the world:

 

Here's a recent article from the telegraph:

 

http://www.telegraph.co.uk/science/science-news/10628703/Children-denied-life-saving-cancer-drugs.html

 

British and European nations hold just as much blood in these issues as Americans. There is no moral superiority, when it comes to medical application.

 

I love bioethics as a concept with medicine and health care; I've gone to a few assemblies of doctors, hospital management, and health care finance groups with this as the central theme. Patients and their families think if you have treatment that can save lives, why not give it out? There's a lot of good reasons why:

 

1. Regulations: the FDA is a complicated web of researchers and bureaucrats in drug approval, who have certain rules and limits on anything that even smells like it could harm human beings during testing. On a cursory level, I agree with this concept of being better safe than sorry later, but it is also this kind of mindset that limits scientific advance.

 

Louis Pasteur in his testing of the Rabies' vaccine, the first human made vaccine in history, was done without extensive prior testing and worse had unmentioned failures in the past that Louis Pasteur had hidden from the medical community. His journals have shown that prior to his successful vaccination of Joseph Meister, he had failed several times prior and had not fine tuned the process.

 

If modern regulatory standards were held, if these facts were known the field of microbiology, pharmacology, and immunology would not have been created.

 

Everyone in health care loves to debate Pasteur, because as unethical as he was, his goals were right and his techniques were onto something much larger, the creation of new medical science.

 

2. Financially: Drug companies are not non-profits and do not create cures for free. They have investors from the usual wall street billionaire to the average office worker with a 401k plan. Our society is founded on the "profit motive", we live by the rule that by investing our resources, then the majority of us can reap the rewards later either from the product or from its sales.

 

If drugs are given away for free or its value comes into question (drug valuation is another area), then how can investors get their investment back. While drugs may seem cheap from the standpoint of base chemicals and mass production once it hits the hospitals, the true cost is research and time in its development. The investment is a cost of time and resources diverted. If people no longer think it is "worth" investing in such areas, then investment disappears from a pharma company, which in turns means fewer life-saving treatments can be produced.

 

Capitalism is a sticky point in this area, the alternative is either we pay higher taxes and have the government direct pharmaceutical research "directly" (which is based on public desire versus need, i.e you can find a cure for AIDS or Cancer with all the money thrown into those two big topic diseases, but what about resurgent smallpox, avian flu, or other retroviruses that researchers are working on now with private investment).

 

There's also another possibility from the individualist, we stop investing altogether since it does not benefit us individually (the Ayn Rand Atlas Shrugged dream, or for me the nightmare of civilization). By the way, there's a hidden danger in Objectivist Libertarianism from this, if taken to the extreme end of individualism, there would be no incentive to pooling resources for non-relevant drugs to individuals, it would reduce overall investment potential and drug production even without government regulations.

 

3. The Good of the Many versus the Few: CNN does not tell you why this is good for the many versus the few. It only repeats one line from the pharma executives, but the truth is there is a majority good versus minority salvation.

 

American Society, despite how much is claimed and championed of minority positions, is a society that supports what benefits most people. In this case, you have only one group of interest in the drugs immediate use: Dying children versus the needs of investors, the needs of researchers, and the need for regulatory approval in order to release the drug for wide use. While you may be able to save a few hundred now, you could be saving a few hundred thousand in a year from now.

 

In medicine, there's a concept that this decision correlates to: Triage.

 

Resources are not infinite, you can't save everyone, but you must do what you can for the majority. Sometimes people think "Many vs. Few" arguments are relegated to socialist vs free market health care debate in the US, but in fact, it is a reality of civilization itself. Even in a single payer system, you can't avoid it.

 

Is this a problem with how society is structured that we would throw dying kids under the bus for progress? or Is it merely how we as human beings have adapted to our way of life, in a way showcasing darwinian principles in how our societies are constructed?

 

Those are bigger questions that people have to answer on their own.

 

Update:

 

http://www.cnn.com/2014/03/11/health/josh-hardy-drug-study/index.html?hpt=hp_c2

A deal was struck between the FDA and the Pharma company; 7 year old Josh will get his medicine

 

However, this was done not by compassion, but a business deal between the government and private sector. It further adds to the question of ethical practice and morality:

 

Is medicine moving beyond the old Compassionate care model to something based on motives and profits?

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I dunno.

 

It's not at all clear that the drug will save the kid.  And if the drug causes a deadly reaction in the kid, and are the parents going to turn around and say, "EVIL DRUG COMPANY killed my baby."  Are they going to scurry a battalion of lawyers to demand compensation?

 

As for cost of drug development ...  If aspirin was discovered today, the FDA won't approve it. If penicillin was discovered today, the FDA won't approve it.  The precautionary principle doesn't help so much when it comes to finding new drugs. But no one wants to be one shafted with birth defects because their mom took thalidomide. The paternalism of the FDA policies denies dying patients their human right to try experimental drugs, literally adds millions to the cost of drug development. 

 

I'd happier if FDA become more of an auditing agency than an approval agency. And let the public decide how much they want to gamble with their health.  But most people don't see it my way. They prefer to have a big daddy in the person of the government making things safe for everybody, so that they don't have to think, or rather so they know whom to blame when shit goes wrong.  I just wish more people saw that deadly costs associated with guaranteed security. 

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"Louis Pasteur in his testing of the Rabies' vaccine, the first human made vaccine in history"

 

This is not correct. The first vaccine was developed not in France by Pasteur in the 19th century, but in England and Germany during the 18th century. And it was Edward Jenner who performed the first "unethical" testing, in 1796, by inoculating an 8 year old boy with a smallpox vaccine. The boy was selected because "he was healthy". Happily his treatment was successful and he lived until 1853 - so the lawyers all went home hungry... :lol:
 

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"Louis Pasteur in his testing of the Rabies' vaccine, the first human made vaccine in history"

 

This is not correct. The first vaccine was developed not in France by Pasteur in the 19th century, but in England and Germany during the 18th century. And it was Edward Jenner who performed the first "unethical" testing, in 1796, by inoculating an 8 year old boy with a smallpox vaccine. The boy was selected because "he was healthy". Happily his treatment was successful and he lived until 1853 - so the lawyers all went home hungry... :lol:

 

 

Jenner used cowpox infections to prevent or lessen future smallpox. There's a difference between "First Vaccine" and "First man made vaccine".

 

Louis Pasteur transplanted the rabies virus from rabbits and dried it out afterward prior to inoculation to weaken it. The difference between Jenner and Pasteur is that Pasteur's methods were artificial, not natural substitute.

 

Without Pasteur modern medicine would not exist, but his methods were very unethical and potentially mortal.

 

----------------------------

 

@crazyfish

 

As for potential lawsuit:

 

That's another problem and it would cost the company money along with potential lives saved from a successful run of this drug.

 

We're not that different in views for the cost of regulation, if you just hold back your libertarianism a little, we should to be friends :D

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There's a difference between "First Vaccine" and "First man made vaccine".

By definition vaccines are made by man. Jenner made his vaccine before Pasteur - therefore Pasteur's vaccine cannot be "the first human made vaccine in history".

 

What you are describing is the different methodologies used by Pasteur and Jenner. But despite their different approaches the outcome was the same: creating "any preparation used to confer immunity to a disease by inoculation", which is the definition of vaccine [Collins English dictionary].  Jenner's work and Pasteur's work both fulfill this standard definition of "vaccine" :)

 

Pasteur['s] ... methods were very unethical and potentially mortal.

 

And so were Jenner's :P

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Fine, remember to tell the French that yourself :P

 

We can disagree, but I still think the two should be separate as Jenner's method was not original and could occur naturally, which Benjamin Jesty would attest as he was the first performer of cowpox inoculation in 1770's, two decades before Jenner (he didn't invent it, he just got famous for writing about it). Pasteur at least developed an artificial process to weaken viruses before transplanting, so he actually grew the virus, weakened it, and passed it on with a doctor (since he was not a physician he couldn't give little joey his shot).

 

By the way, prior to Pasteur actually offering the term of "vaccine" as a nod to Jenner, Vaccine was defined merely as inoculations with cowpox to prevent smallpox. :P In a way, without Pasteur defining it that way, Jenner would have been relegated to a one hit wonder :o

 

The fun of medical history.....

 

However, back to topic, yes Jenner was extremely unethical. He infected his gardener's son with cowpox, then infected him with smallpox. I don't know about you, but that sounds like attempted murder without proven research or trials.

 

Medicine in those days allowed for Frankenstein type such situations to occur; unethical and committed researchers could do as they will without a regard to human life as long as they were successful.

 

Nowadays, we have placed limits on those extremes, but we face a different issue of inaction in times of need and a goal oriented medical research.

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The fun of medical history.....

 

However, back to topic, yes Jenner was extremely unethical. He infected his gardener's son with cowpox, then infected him with smallpox. I don't know about you, but that sounds like attempted murder without proven research or trials.

 

The gardener must have pissed him off,  planted the wrong color roses or something  :o.

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I still think the two should be separate as Jenner's method was not original and could occur naturally

 

With respect, what you think is not the point. It's what the rest of the world thinks that matters. The cowpox needed preparation, by a human, and application, by a human, to a suitable patient, selected by a human.  That is what makes Jenner's work a "vaccine" within the standard definition agreed by everyone else:

 

"any preparation used to confer immunity to a disease by inoculation"

 

Benjamin Jesty would attest as he was the first performer of cowpox inoculation in 1770's, two decades before Jenner (he didn't invent it, he just got famous for writing about it).

 

Um, did you not read my earlier post where I already pointed this out? :P

 

Jenner was extremely unethical. He infected his gardener's son with cowpox, then infected him with smallpox

 

Um, did you not read my earlier post where I already pointed this out? :P :P

 

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Zombie i dont see benjamin jesty mentioned :P

 

Also i never acknowledge his ethics prior to my last post :P

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Zombie i dont see benjamin jesty mentioned :P

 

Why would I specifically name Benjamin Jesty? :huh: Benjamin Jesty was not the only person who was active in England before Jenner. And others were involved in Germany as well. That's why I said: "The first vaccine was developed not in France by Pasteur in the 19th century, but in England and Germany during the 18th century."

 

Also i never acknowledge his ethics prior to my last post :P

 

You were just repeating what had already been said, adding nothing new.

 

Anyway, at least you now agree that Pasteur's vaccine was not "the first human made vaccine in history".

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Only to brits, for the rest of the world, I will still hand it to the french :P

 

Still, we agree on the most important part, Jenner was unethical in how he conducted himself.

 

By the way, how does nhs handle experimental treatments. Do you guys make special exceptions like the Us? Or do you guys let people live or die without the option?

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Only to brits, for the rest of the world, I will still hand it to the french :P

 

It's your choice to be at variance with the established knowledge base, just don't hold your breath waiting for science history to be rewritten to fall into line with your singular view any time soon :P

 

Pasteur's work on vaccines built on the earlier work, and a lot more besides - truly he is a science giant. He's been called "the father of microbiology" for good reason. His work speaks for itself and doesn't need to be augmented by an inaccurate claim that his was "the first human made vaccine in history".

 

Still, we agree on the most important part, Jenner was unethical in how he conducted himself.

 

Actually it was you who raised the question of ethics in your opening post when you stated that it was Pasteur who was "unethical" in how he conducted himself: "Everyone in health care loves to debate Pasteur, because as unethical as he was...."

 

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Actually it was you who raised the question of ethics in your opening post when you stated that it was Pasteur who was "unethical" in how he conducted himself: "Everyone in health care loves to debate Pasteur, because as unethical as he was...."

 

 

Actually my entire Blog entry is centered on Bioethics? :)

 

That point holds true, because health care people do like to debate Pasteur when you talk to them about bioethics. Ask around? :P

 

Also, I have noticed you are deflecting from my question from before about the UK NHS:

 

By the way, how does nhs handle experimental treatments. Do you guys make special exceptions like the Us? Or do you guys let people live or die without the option?

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No, I just don't have the information. But now we seem to have dealt with the other matters I'm looking into it

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No, I just don't have the information. But now we seem to have dealt with the other matters I'm looking into it

 

Any insights?

 

Or are you onto the next blog :P

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