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Author Topic: Is it acceptable to lie, to over-egg the issue of antibiotic resistance?  (Read 562 times)

Offline MarkPawelek

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Antibiotics - lie or tell the truth?

This morning, on BBC World Service, I was listening to a radio review programme which ran a short story on antibiotics.

The radio announcer asked why there were no new antibiotics and rhetorically answered her own question. She said there were 3 reasons:
1. No new class of antibiotics has been discovered.
2. Drug companies are not interested in developing new antibiotics. No money there for them.
3. Clinical trials take too long. 3 decades ago there were 30 companies developing antibiotics. Today there are none.

Reading the history of penicillin, it seems the original 'clinical trials' took months and consisted of individual medical cases!  It takes years today and every trial proceeds a laborious route.

As we all know, bacteria evolve resistance to the antibiotics we currently have. Several non-scientifically inclined friends of mine regard disease with terror. Especially after the last Ebola outbreak. It was put to me, by a well educated finance journalist, editor, and analyst (PhD) that up to half the population of the planet could be wiped out by a new disease. I'm personally more worried about harm caused by paranoia in the population. In my view, pessimism like this more often leads to a despair and cynicism about the human condition. Panic is not conducive to rational action.

I know there are several small groups working on new antibiotics who are prepared to by-pass drug companies to get them developed. I put the current antibiotic situation entirely down to the length and expense of clinical trials. The one size fits all approach.

The question I have : is it acceptable to lie, to over-egg the issue of antibiotic resistance?, perhaps to raise awareness  [ As this radio announcer did when she said "No new class of antibiotics has been discovered" ]

I know for a fact that new classes of antibiotics have been discovered. They have not gone through clinical trials. Many of them discovered in the last 2 years.
« Last Edit: 24/10/2016 23:37:02 by chris »


 

Offline evan_au

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Quote from: MarkPawelek
bacteria evolve resistance to the antibiotics we currently have.
Most antibiotics come from nature.
The antibiotic resistance genes already exist in nature, for example in soil bacteria.
It is just a question of time before the resistance genes spread from soil bacteria into the diseases that normally infect humans, and become endemic.

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Several non-scientifically inclined friends of mine regard disease with terror
It is true that we have had a golden age of being able to cure many bacterial diseases, over the past century. People regard antibiotics as a magic wand that will cure anything.
But we still have no effective treatment for viruses. And yet some people insist on being given antibiotics for viral infections. The most effective protection against viral diseases are:
- vaccination. But there are many people opposed to this
- infection control - like good plumbing, hand-washing, bed-nets, mass thermal imaging of people arriving at airports and isolation of infected individuals.

It is possible that these may become the most effective control for bacterial diseases too.

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the original 'clinical trials' took months and consisted of individual medical cases!
Things can happen very quickly in wartime.

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is it acceptable to lie, to over-egg the issue of antibiotic resistance?
Journalism relies on sensation. "Disaster" and "Miracle" are the two most sensational categories.

If a science story isn't sensational, it gets beaten by the cute furry animal story, the latest celebrity fashion story, or the robbery/car accident story (let alone politics, finance or sport).

Is our current model for use and development of antibiotics broken? Definitely. It needs to be improved.
- Are there candidates around? Yes; one researcher found some novel antibiotics in her own back yard - but had no way to culture the organism producing it, which will really slow down safety and effectiveness testing and commercialization.
- Will antibiotic resistance appear? Definitely.
- We need to control the use of antibiotics carefully to slow down the spread of resistance... And there is no profit in that!

Perhaps the next generation of antibiotics can only be produced by genetic engineering it into yeast or some other easily-cultured organism.
And perhaps development can only be funded by the government or military or philanthropy, since the profit motive is clearly not enough.
« Last Edit: 23/10/2016 21:01:50 by evan_au »
 

Offline Bored chemist

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Reading the history of penicillin, it seems the original 'clinical trials' took months and consisted of individual medical cases!  It takes years today and every trial proceeds a laborious route.

I don't think the trials for thalidomide took very long.
There's a reason why they take a long time these days.

Drug trials can be "fast tracked"- they did it with the ebola vaccines- but you need to have a good reason.

I find it hard to believe that no drug company is looking at new antibiotics, not least because they keep finding them
These
https://en.wikipedia.org/wiki/Teixobactin
https://en.wikipedia.org/wiki/Lugdunin
were the first couple Google found for me.
« Last Edit: 23/10/2016 09:54:45 by Bored chemist »
 

Offline evan_au

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Would it be acceptable for a government to declare new antibiotics a state secret, to be used only in cases of national security (eg treating soldiers or the head of state)?

This would certainly delay the emergence of antibiotic resistance...
And the military is not particularly interested in making a profit. (At least, we hope not!)
 

Offline Bored chemist

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Would it be acceptable for a government to declare new antibiotics a state secret
No.
 

Offline exothermic

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The radio announcer asked why there were no new antibiotics and rhetorically answered her own question.

2. Drug companies are not interested in developing new antibiotics. No money there for them.

February 22, 2016
Scientists pave way for new generation of superbug drugs.https://www.google.com/amp/phys.org/news/2016-02-scientists-pave-superbug-drugs.amp
 

Offline MarkPawelek

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Thanks for the clarification on the meaning of evolve. I consider gene transfer an evolution when the organism with it survives, prospers and is fitter for its environment.  Mutation and gene transfer may be entirely different mechanisms but the net result - changed DNA - when it improves the progeny's fitness - drives evolution.

Anyhow. It was that statement no new class of antibiotics has been discovered which upset me. That's what I want to talk about. Is it acceptable?

Is it OK to hoodwink the public if you believe it drives a good policy forward?

Is it sustainable to hoodwink the public?  Once they lose confidence in experts and scientists, how do you get that confidence back?
 

Offline MarkPawelek

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thalidomide!!

Is a fallacy. A false dilemma [nofollow]. There's a cost benefit equation with new drugs. Do we keep them away from the public and potentially save 10 lives with better trials, or do we distribute them to save hundreds of thousands of lives now?  When a drug is transformative and life saving on a massive scale it should be made available ASAP. When it was released, medicine had never seen anything like penicillin. It saved countless lives.

The issues is not no clinical trial vs. decade long trials. It's what is the best way to treat a sick person who is dying?  It might be 2 years of clinical trials vs decade long trials.

I actually implied this in my OP. I said there is a one size fits all approach to regulating clinical trials.
 

Offline MarkPawelek

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evan_au is unduly pessimistic. S/he only looks at the downsides.  We should be able to develop new antibiotics faster than evolution can ambush us.  Biotech is more advanced than ever before, advancing more by the minute. Everything s/he says may be right in a world with no technological developments. Not in our world.

Vaccination refusal is fast becoming socially unacceptable and the lies told by Luddites against vaccination are fully exposed.
diseases that normally infect humans becoming endemic - only if we let them by not developing new antibiotics

Why am I not surprised to find evan_au justifying what seems to be epistemological relativism and ends-means justification?

My life experience of other people leads me to conclude that pessimism over the human condition goes hand in hand with epistemological relativism and ends-means justification.
 

Offline evan_au

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Quote from: MarkPawelek
evan_au is unduly pessimistic. S/he only looks at the downsides.
Maybe. Or maybe I am just calling a half-full glass for what it is.

The "Magic bullet" concept that you can just take a broad-spectrum antibiotic and cure (or prevent) almost any disease has lost its shine. Major surgery like hip replacements may become too risky if the infection rate increases.

The one area we have advanced most rapidly is in DNA sequencing. So perhaps it may become possible to sequence the genes of whatever is ailing you, and select the right antibiotic that will kill it most easily?

There are hints that a mixture of antibiotics may be more effective than a single antibiotic.

Bacteriophage therapy was always limited by the specificity of the phages; with DNA sequencing we may be able to give the right phage to counteract the infection.

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It might be 2 years of clinical trials vs decade long trials.
It is true that drug regulations are tough. But there are some ways around it:
- Current Western practices are to compare a proposed treatment against the best-performing treatment.
- Some researchers are looking at neglected tropical diseases, for which there is currently no effective treatment. In this case, there is a very low bar, and the testing phase can be a lot quicker.
- In some ways, this is an information-processing problem. There are some people who are desperate for an alternative treatment, and there are organisations who are desperate for human subjects. Putting the two groups together - there should be an app for that!
- The best-quality trials are "blinded" trials, where the patients and nurses don't know who is receiving which medication. This does mean that you need twice as many patients.

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We should be able to develop new antibiotics faster than evolution can ambush us.
"Nature will find a way.." according to Jurassic Park! This also applies to antibiotic resistance.

The fact is that we haven't been very successful in developing new antibiotics, but have mostly copied nature. And nature already has defences against these antibiotic weapons. At best we have been able to tweak the natural antibiotics to extend the lifetime a little.

Antibiotics are a valuable resource. An uncomfortable fact is that we have been squandering valuable antibiotic resources by using them inappropriately on humans, animals, and by dumping it in streams and water supplies via sewage systems, all of which promotes the development and spread of antibiotic resistance.

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epistemological relativism and ends-means justification?
I am not quite sure what this means. Can you give an example, and show what you feel is a more balanced view?

Quote
S/he
The text will flow more freely if you just use "he".
 

Offline puppypower

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The main problem is the life sciences are too dependent on a casino approach to research; statistical. Like in a gambling casino, the house; bacteria, wins over time. The researchers can only expect to have some good days at the research casino, which they dream will include large jackpots. But more often than not, the house will win. The lure of large jackpots still attracts smaller researchers. While many of the larger organizations are shifting from slot machines to black jack, since black jack; some products, have better odds for success.

Major advances will appear, quickly, when the life sciences finally use a more realistic model for life. A more realistic model of life will be based on the premise that water is a co-partnership in life, with the organics. If you took the water away from any strain of bacteria; dehydrate, no strain of bacteria; past, present to future, will be alive anymore. Water is a common thread for all bacteria.

Water is responsible for why proteins fold into perfect folds where statistics does not apply. The current approach ignores water, to the level of its contribution, and makes believe the bacteria is an organic centric roulette wheel. We spin the organic wheel, hoping to win a jackpot. It is quite sad that biology is so stuck at the pre age of reason. It still prefers the whims of the gods.

The impact of water is not new. When the structure of DNA was first being inferred by Watson and Crick, in the early 1950's, they assumed the DNA was triple helix, where the phosphate on the three helices, were clustered by magnesium ions. It turned out, there was ten times as much water in the structure then they had assumed. This extra water precluded a triple helix since the water would tie up magnesium ions. The final model of the double helix was consistent with the amount of water present and demonstrated the role of water.

Upon closer examination, the bases of DNA have extra positions that can form hydrogen bonds, beyond what the base pairs use. These were designed for water. It  has been demonstrated the DNA will not function without water, while the degree of hydration will determine the overall structure of the DNA, and that there is a double helix of water that runs parallel to the organic double helix.

In the image below, each base pair has 5 or 6 hydrogen bonded water. This water further hydrogen bonds to other water to form a double helix of water, one in each the major and minor grooves. This is what real DNA look like. Gambling casino DNA is different and does not make use of water but assumes dehydrated DNA is active.

 

Offline exothermic

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Do we keep them away from the public and potentially save 10 lives with better trials

or do we distribute them to save hundreds of thousands of lives now?

When a drug is transformative and life saving on a massive scale it should be made available ASAP.

So don't even bother conducting the safety trials in an effort to save the masses at a faster rate?

What if something like liver failure is found to be a side effect after the fact?

No thanks.

 

Offline Bored chemist

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  When a drug is transformative and life saving on a massive scale it should be made available ASAP.
They used to do that- then things went wrong like thalidomide and this
http://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanilamidedisaster/default.htm
(and others- Heroin was named for it's heroic property of being effective but not addictive)

And so they stopped being quite so cavalier about it.
However, as I said, they do fast track trials.

And, on the other hand, they also withdraw drugs that passed the initial trials.
https://en.wikipedia.org/wiki/List_of_withdrawn_drugs
 

Offline alancalverd

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The accusation that "one size fits all" is unfounded. Each proposed clinical trial is assessed on its balance of risk/benefit and expected statistical requirements.

The world has certainly grown more cautious after thalidomide, simultaneous nonescalated dosing, and some distinctly unethical studies of untreated syphilis, lobotomy, and suchlike scandals.

Comparison against current gold standard treatment raises two quite different questions. In the UK we might permit a trial aimed at "no worse" if there was a potential saving in cost to the NHS or inconvenience to the patient, but the FDA demands "superiority" and this may only be demonstrable in, say, lefthanded reheads, so you would need a very large trial and some very clever statistics to find the niche advantage. Problem is that you would by then have spent a vast amount of money to discover a tiny market, so it can take a very long time.     

Where the target patient group is small, well characterised, and has a short life expectancy, the trial may indeed be quite brief, but this sort of work isn't going to cure endemic disease in a poor country. Ebola was a special case where the target group was pretty well contained and had a lousy prognosis, but it was worth the cost, effort and risk of a quick development in order to prevent a very virulent contagion from becoming endemic. At the other end of the economic scale, if the intention is to prescribe mass medication for a relatively trivial problem, you need a very strong demonstration of long-tem safety.

External politics can also influence the trial. I was recently working on one which was halted because, if successful, it will substantially reduce the demand for a service to which massive resources have already been committed. The political repercussions were such that the goalposts were moved from "no worse" to "substantial superority" but we did not have sufficient publilc funding to demonstrate the latter, so we are now offering it as an experimental treatment for private patients only - with all the political overtones that that entails! - because on the basis of preliminary results it would be unethical to hush it up completely.   
 

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