Animal Testing - Right or Wrong?

[Sayonara]

well, it would offer a huge deterrent to people doing illegal stuff.

Would it though? Death and incarceration don't always work as threatened punishments, so why would medical testing work better? The risk of being caught AND sentenced is fairly low for many types of crime.

 

Although, the point of my question was why specifically christiannnna decides that testing on "criminals" is more justifiable than testing on animals. I'll be interested to hear what a "criminal" is, as well.

[iNow]

Main Entry: criminal

Function: noun

Date: circa 1626

 

1 : one who has committed a crime and been caught by the authorities, but who could not afford a better lawyer

 

[Sayonara]

So, for example, someone who has been summoned to court for a driving offence?

[lucaspa]

I personally think animal testing for beauty products is wrong, but whats done is done.

 

A lot of us are uncomfortable with animal testing for this use. Fortunately, the cosmetic industry is the one that leaped at using cultured human fibroblasts for their initial testing, so animal testing for this use (particularly the Dray's test) is way down.

 

But I read somewhere that researchers try to make sure the animals get the least pain.

 

It's required. The guidelines for the forms we have to fill out require that I (and any researcher using animals) provide the means to minimize the pain and stress to the animals. A veterinarian must be on every IACUC and one of their tasks is to ensure that all protocols will have adequate control of pain. In the last protocol I submitted, I had the rabbits being injected with an opioid pain killer each day for 3 days after the surgery. The vet changed that to a fentanyl (an opioid) patch that would be on for 5 days because that would provide better pain control. So that's what I'll do.

 

And all of the animals (there aren't many) get treated good, and fed.

 

Well, there are quite a few animals. But yes, they do get treated well and fed well.

 

But they should start using criminals.

 

Humans still have some rights even when convicted of a crime. Remember, the Jews and other humans experimented on by Dr. Mengele and other Nazi scientists were criminals by their laws. We really don't want to start down that path again, do we?

[jdurg]

I think everyone, except Jdurg, is going to be surprised at the amount of data is in an FDA approval package.

 

Hehe. You got that right. It is AMAZING how much data and documentation get submitted to the FDA. Even if we think that the compound works and is safe and have dozens upon dozens of medical individuals looking at it, the FDA puts the number of people we have to shame. I, for legal reasons, can't disclose specifics but there have been numerous products that appeared fine and safe, but further analysis by the FDA resulted in the drug being rejected. For me, as a colleague in the industry, it's frustrating as all hell the amount of work I have to do to be prepared for a random FDA audit, but at the end of the day when you realize why we are doing that it isn't bad at all.

 

 

I personally think animal testing for beauty products is wrong, but whats done is done.

 

 

I agree with this. I in no way support the use of animals on cosmetic testing. You don't need a cosmetic to live your life. If you don't put makeup on, you aren't going to die. In addition, there aren't new chemicals being created that have absolutely not toxicology data on them in the cosmetic industry like there are in the pharmaceutical industry.

[PeacheyCarnehan]

Can we see some compelling evidence that "most drugs fail when they are tested in humans" is actually a fact? I suspect that it is true, if only for biochemical reasons, but it is good to get into the habit of evidencing such claims on a site like this.

The statements below are from FDA documents or communications written in 2006 that are talking about improving the drug development process:

 

'Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.'

http://www.fda.gov/bbs/topics/news/2006/NEW01296.html

 

 

'Consider just one stark statistic: Today, nine out of 10 compounds developed in the lab fail in human studies. They fail, in large part because they behave differently in people than they did in animal or laboratory tests.

 

'The initiative we are here to discuss is one of many we at FDA are implementing that will remove some of the hurdles from the earliest phases of drug testing and medical development in people, so that researchers can more rapidly establish whether or not a new compound truly has a real clinical benefit for people. This is about saving lives — and building medicine’s future.'

Andrew C. von Eschenbach, M.D.

Acting Commissioner of Food and Drugs

 

http://www.fda.gov/oc/speeches/2006/fdateleconference0112.html

 

 

 

Bear in mind that the anti- side needs to find a reason, any reason, to support their objection. The pro- side needs no such reason because the system works, and is constantly improving.

The system doesn't work, unless you mean that getting a minority of drugs through clinical trials so they are approved, is proof that it is working. That is after all the drugs had lab animal data that the drug companies thought was predictive of the drugs' ability to get through the clinical trials. Remember, the clinical trials are the most costly part of the drug development process. Do you think a drug company is going to risk all those millions on putting a drug through the trials unless they are very certain it will succeed or succeed long enough for them to make a profit? The lab animal data, they think, tells them the drugs have a good chance of doing so. It's not the only data, as there are many other methods, but as people here have said, if in silico indicates a drug is safe but rats indicate it's not, then it's goodbye drug. The lab animal data, being in living organisms, is what they place so much reliance upon - it must be if it overrides the results of in silico or any other pre-clinical testing. And that reliance is misplaced. Most new drugs fail in the clinical testing on humans.

 

Also, the drug companies and their minions do need to find a reason. That is why they have bribed physicians to prescribe their drugs and why they have enough salesmen and women to form an army that would be big enough to invade a small country. It is the reason why they have a large number of lobbyists to pester every politician and spend millions doing it. It is also the reason they place false or misleading advertising about their drugs to make them look better than they are - sometimes in ways that could lead to danger. It is also the reason so many people in the FDA, NIH, IRBs and XYZs have received money from them - even those whose job it is to decide on which drugs to approve. It is probably also the reason they give top jobs to top officials who leave jobs in places like the FDA and NIH or government posts.

 

 

From the Los Angeles Times. 22nd December, 2004:

'And when congressional critics surface, the industry has a way of winning them over: This year's top two recruits had recently launched a congressional investigation of conflicts of interest at the NIH.

 

'Rep. W.J. "Billy" Tauzin (R-La.), as chairman of the House Energy and Commerce Committee, had cited "secret consulting fees and stock options from drug companies" to NIH scientists as a reason for requesting that the agency produce documentation of all the payments. Tauzin, who did not seek reelection, was hired this month to be the president of the Pharmaceutical Research and Manufacturers of America, the group that represents the nation's largest drug companies.

 

'Rep. James C. Greenwood (R-Pa.), who led three hearings this year on NIH conflicts of interest, had criticized the agency for allowing its scientists to use "a swivel chair" to make government decisions while taking drug company fees. In July, Greenwood announced that he would give up his position as chairman of the Energy and Commerce subcommittee on oversight and investigations and retire from Congress to become president of the Biotechnology Industry Organization — a group that urged policymakers this year not to prohibit NIH scientists from paid consulting deals.'

 

 

Greenwood did take up that job. These two cases are like gamekeepers suddenly becoming poachers.

 

In December, 2004, the Los Angeles Times said:

'For 15 million Americans, it is a daily ritual: gulping down a pill to reduce cholesterol.

 

'They do it because their doctors tell them to. Their doctors, in turn, rely on recommendations from the National Institutes of Health and its scientists, such as Dr. H. Bryan Brewer Jr.

 

'Brewer, as a leader at the NIH, was part of a team that gave the nation new cholesterol guidelines that were expected to prompt millions more people to take the daily pill. He also has written favorably of a specific brand of cholesterol medication, Crestor, which recently proved controversial.

 

'What doctors were not told for years is this: While making recommendations in the name of the NIH, Brewer was working for the companies that sell the drugs. Government and company records show that from 2001 to 2003, he accepted about $114,000 in consulting fees from four companies making or developing cholesterol medications, including $31,000 from the maker of Crestor.

 

'Brewer was far from alone in taking industry's money: At least 530 government scientists at the NIH, the nation's preeminent agency for medical research, have taken fees, stock or stock options from biomedical companies in the last five years, records show.'

 

SEE THE ARTICLE FOR OTHER EXAMPLES SUCH AS:

'Dr. Harvey G. Klein, the NIH's top blood transfusion expert, accepted $240,200 in fees and 76,000 stock options over the last five years from companies developing blood-related products. During the same period, he wrote or spoke out about the usefulness of such products without publicly declaring his company ties.'

 

December 22, 2004 Los Angeles Times.

http://www.latimes.com/news/nationworld/nation/la-na-nih22dec22,0,6610329,full.story?coll=la-home-headlines

 

'Note: In February 2005, NIH Director Elias A. Zerhouni placed "'drastic' restrictions on stock ownership and other forms of outside income ... for all agency employees," according to a Washington Post article by Rick Weiss.'

 

 

BUT HOW CAN THEY CHECK? It says in the L. A. Times article that Zerhouni didn't know the extent of the problem and that bureaucratic means were used to hide the payments from Congress. I don't believe that 'conflicts of interest' are no longer a problem in the NIH. What was hidden once can be hidden again. The Once and Future Hidden Thing.

 

It also says that some of these NIH employees had used their NIH credentials (or allowed them to be used) when promoting some drug - as if the drug was being endorsed by a government agency.

 

They also say:

'The pharmaceutical bonanza that has swept the country in the last decade has created one of the most influential lobbies in Washington. A total of 3.5 billion prescriptions — medicating about 129 million Americans — were filled last year. Drug industry revenue in the U.S. tops $231 billion annually. The drug companies donated $41 million to candidates for federal offices in the last four years, according to the Center for Responsive Politics.'

 

And add:

 

"The pharmaceutical industry has never been more powerful than now," said Rep. Henry A. Waxman (D-Los Angeles). "The companies have made investments in the people who have power in Washington. And they've gotten a very good return on those investments."

 

 

When I say "the lesser of two evils", I am using the common English phrase. Perhaps I should have said "the lesser of two not brilliant choices" to remove ambiguity. I do not think that testing on non-humans is inherently evil; such an attribute can only be applied to intentions, not to mechanisms.

Ah, well, I use 'vivisection' in its now common meaning. 'Evil', as you rightly point out, has taken on a common meaning which has no bearing on its earlier philisophical/religious sense. It is quite common now to talk about evil landlords whose only crime is to cheat their tenants. But it is now used in common English phrases.

 

 

We are not discussing vivisection, despite your repeated claims that we are. I have already warned you about this and the next infraction (in the thread, not in this post) will result in warning points.

 

My reply to the above, substituting vivisection with "animal trials", is that you cannot validly make those same claims for all experiments across the board.

To save the delicate sensibilities of the supporters of cruel experiments - although they are not offended by the torture, terrorising and killing of rats and monkeys - I will henceforth use the term 'cruel experiments' when referring to lab animal experiments that don't involve the use of a knife on living tissue. And to save myself from being banned. That way, I can still be here in years to come when this thread is 200 pages long.

 

However, if I don't think this thread is generating enough interest from those who are undecided, I might visit less often. I like to make better use of my time. I prefer threads with lots of readers and lots of contributors.

 

Even if we use the term 'lab animal experiments' those animals possess health and life. It is wrong to take those away from them. It is wrong to use them in painful or potentially painful ways that don't benefit them. Even those that are drugged senseless are often killed. That is wrong. Anyone who can't see that, is probably incapable of understanding. Just as anyone who couldn't understand that it was wrong to keep slaves was unable to understand the issue.

 

 

 

 

That change in the law came about as a result of the rational discussion of new and more informative medical data. It was not changed on a subjective whim.

 

I would respectfully suggest that if you are going to argue about how laws are formulated and applied, then you will suffer a crushing defeat on that front, given that the subject is a major aspect of my career.

MPs and judges changed their minds about abortion. Even deep philosophcal thought results in the forming of opinions. There is no universal, immutable law that says one thing is right and another thing is wrong. It is all opinion. At one time they were of the opinion that it was wrong and then, at another time, they were of the opinion that it wasn't wrong. In the Republic of Ireland, where they will have the same data, they still think it is wrong. No doubt, it is part of their constitution. That will be informed by Catholic doctrine. But they are of the opinion that their beliefs are right or that it's right or of benefit to them to respect those beliefs. They might change their minds if they get even newer data or the Pope changes his mind. Constitutions can have amendments added when opinions change.

 

Laws are opinions. Some, like the laws against killing and theft, are accepted by most people. Some are of the opinion that these laws can be ignored in certain circumstances. Others are of the opinion that they can never be ignored, not even to save their own lives or the lives of others. The laws of physics are not opinions and they never change. Our understanding of them might change but they don't. Human-made laws do change.

 

 

 

And that is just your opinion. Funny how "just an opinion" is good enough for you, but not good enough for the pro-stance.

 

What you have to realise with regard to that kind of scenario is that there is no absolute moral position. Stating that your moral outlook is the only right one is an extraordinary claim which requires extraordinary evidence.

 

That is why I said that we all have different opinions. Laws are opinions. It is presently the opinion of the law in the UK that it is wrong to put people to death for capital crimes. Fifty years ago it wasn't. I know that many here don't have the same opinions about what is right and wrong, cruel and not cruel.

 

No no no no no no no no no no no no no no no no no.

You sound like Jim in The Vicar of Dibley.

 

Yes, that on its own is true. But it does not mean that you can take a propaganda term and apply it to something which it does not mean in order to colour your opponent's arguments.

You say it is a propoganda term but I say it is a word that can more accurately describe what a disgusting and vile business it all is. It is to medical science what the Roman gladiatoral contests were to sport.

 

No, they are not. I strongly suggest that you abort that approach.

Laws often reflect the current ethical beliefs of any nation, or those of the lawmakers. They sometimes reflect the vested interests of the lawmakers. That some beliefs are common to most people doesn't mean they aren't beliefs. Beliefs change as opinions change. It used to be legal to throw Christians to the lions. Or to execute people in this country for pickpocketing or murder. Opinion, amongst those who make the laws, now is that those things are wrong. There are countries where adulterers can be stoned to death. I am of the opinion that that is wrong. And cruel.

 

 

 

I don't understand how you expect your opinion to make any difference to the reader if you truly believe that stating "laws are opinions" somehow invalidates what they state. That is not internally consistent.[/quote

I do think laws are opinions. I happen to agree with most laws. Those that protect us from the depredations of others. I wouldn't expect thieves and muggers to accept my beliefs that these laws are just. But I would still tell them that I think they are.

 

That doesn't make a comment on what you should believe, because it only represents what you have chosen to read.

I have read the opinions of those who believe the opposite of my beliefs. As I said somewhere, I used to believe that non-humans could be used as models for humans. Only when I started to do my own studying did I realise that what I had been told or read was wrong.

 

 

And now you know that vivisection is not really anything to do with drug testing. Hallelujah! You can stop wasting your time on fiction.

No. I know that it is anything to do with cruel medical research - and some other forms of research - which use any animal to test drugs, psychological reactions, and other things. As I mentioned earlier, testing chemicals on servicemen was vivisection. As was testing drugs such as LSD if it was against their will or without them being fully informed.

 

 

 

If by "free speech" you mean using an incorrect word which has very negative connotations in common language, then yes. Although I have to add that I would also qualify that by pointing out that you would also be using your own definition of "free speech".

 

Your reasons for making up the definition of vivisection don't go any way towards justifying it on any level.

 

Killing rats or monkeys that have had drugs tested on them to find out what the drugs did to them is already very negative. If you think there is nothing wrong in doing what you would call vivisection (actually cutting into living animals), you have no reason to object to the 'wrong' use of the word. Objecting so strongly because a word is used inappropriately - according to you - seems a bit much, especially if there is nothing wrong with the practice. I don't demand changes from people here who use terminology I disagree with. There is a world-wide concerted effort to make medical research look clean and humane. Using anyone against their will, human or not, is not humane. Forcing them to ingest chemicals, even if they are anaesthetised, is not humane. And killing them is not humane.

 

 

None of those are euphemisms - they have precise meanings.

They are used in place of words with unpleasant meanings to distance the person doing them from the reality of what they are. A slaughterhouse is a place where slaughter is done. 'Abattoir' is a French word for the same place but is only a sound with no negative associations in English. 'Abattoir' is a euphemism in English. Why won't some people use the correct English word?

 

 

That is a product of your imagination, not the words themselves. Additionally, if you truly object to this phrase on those grounds, then by choosing to use "vivisection" instead (which evokes images of animals carved up and plugged in), then surely you are just being a complete hypocrite?

The images conjured up by the word 'vivisection' are those of victims who feel fear and pain, and images of beings used against their will for the benefit of others. That is what cruel medical experiments are, even if no cutting is involved.

 

 

And in certain technically-minded conversations, that is a word which is used. However in the common language it isn't, because people who are talking about their new tattoo or their floral deftness don't talk like medical dictionaries.

And people in general don't have etymological meanings in mind when they use words, such as 'vivisection'. They use them in the senses that they understand or in ways that they are used now. And, in recent years, vivisection has taken on a wider meaning. It might very well have started amongst anti-vivisection campaigners but it has been accepted now. As I said, that's how language changes. Many words we use today have almost the opposite meaning (or a very different meaning) to what they did a few hundred years ago.

 

 

Those changes can't be crow-barred in by an agenda which wishes to equivocate with completely different topics. Let me make this absolutely clear: you are not going to fool anyone here on this point, and if you genuinely believe it, then you need to have a long hard think about why.

I am not crow-barring anything. I am using a word as it is now used. It is an honest word that lets people know that cruelty and other wrongdoings are involved in the practice.

 

You using a word incorrectly and someone making a statement you disagree with are not equivalent.

I believe they are. My definition of 'suffer' is obviously very different to the one used here by, I think, most of the contributors. And when people say that forcing any animal to be the subject of cruel experiments is not cruel, well, words fail me. I can't understand the thinking of such people.

 

 

The idea is that you listen to the arguments and decide if the evidence supports them, and then you are able to apply the differences to your opinion. By iteration you shift your opinion closer to representing the true state of affairs.

That is what I did when my opinion of medical research changed. But, in this type of debate, what is truth? So many of the positions are based on opinions.

 

 

Believe me, sufficiently compelling evidence will swing people's positions. People who consistently fail to be swung from the pro-testing to the anti-testing camp are not just being stubborn or difficult: in actuality they are simply not being given any compelling evidence. That is hardly their fault, is it?

A few posts above, when I had said that everything I have read has led me to my present beliefs, you said that my beliefs only represent what I have chosen to read. And, by implication, I have chosen not to read things that differ from my views.

 

I had the compelling evidence. That is why I changed my opinion. Since then, I have seen nothing to convince me otherwise.

 

Support this or don't make the claim.

You expect me to prove that lab animals don't have good lives? It is plain for anyone who thinks they shouldn't be imprisoned, tested on and killed, that they are not having good lives. If they are, so are human prisoners who are given food and beds. In fact, the human prisoners are better off as they are not used for testing and, in this country, they are not killed.

 

 

In that case, brain damaged humans who were fed and watered and then killed would have a good life. I gave a link to some information about rats that were given more freedom after generations of living in labs. Their instincts soon came into play. Any animal that roams freely in its natural state is being denied its natural life if it is imprisoned. One reason why humans are imprisoned as punishment.

 

Well you have some problems here. First, you have already stated that this is your opinion (others share it, but this is beside the point). Second, you have made the contention that "just an opinion" means that a principle can be ignored if one does not believe in it. So any effort to use the above quote as a basis of argument is fundamentally contradictory.

Anyone who believes humans should be slaves wouldn't understand that it is wrong. That is my opinion. Is it yours? At one time, white people could ignore the wrongness of slavery because they had the law on their side. Then one day they woke up and found that the law was no longer on their side.

 

Also, it is not a matter of people "not understanding" what is right and wrong, as if there were some absolute and ineffable compass. It is a matter of people being capable of making value judgements. How many rabbits do you think a human life IS worth? Will the number change if you know the rabbits won't be killed?

How many brain damaged humans are worth how many non-brain damaged humans?

 

As I stated before in a reply to you, this is not an issue. We know (most) animals can feel pain. The issue is in how their experience of suffering compares to ours, which is orders more difficult to establish. This is not something that is used as an "excuse" to allow people to continue doing their evil and pointless experiments on animals. If compelling evidence emerges that animals share the human experience of suffering in terms of torture, then you can rightly expect a swift and robust response from the bodies regulating animal testing.

The regulatory bodies have proved how unreliable they can be. As I said, I give the benefit of the doubt to those who can suffer. We don't know who is suffering what or how much. It is callous to go on subjecting them to things that might be causing them more suffering than any human could ever know. Just as other species have senses that we don't have or senses more refined or stronger than ours, they may have the capacity to suffer in ways we can't measure.

 

I don't think that is generally true at all, certainly not without expert command of very specific training which is not general fare for most people.

Many people have said that just having their minds taken off some pain, such as talking to someone, or going shopping, can help to lessen the pain. Or becoming engrossed in some task. Slight pain can disappear completely.

 

No proof, sure. No evidence, wrong. It does rather depend on what species you are considering, granted, but we do know a great deal about endocrine and neurological systems in many animals used as test subjects. Your personal lack of knowledge on the subject does not qualify as a rebuttal.

As other animals are not the same as humans, we can't know what they are feeling. It doesn't matter how much we study them. Anything we postulate about their subjective feelings based on their responses to stimuli can't be verified except by asking them. Is there a doctor Doolittle in the house?

 

That the definition you pick out of a dictionary and the common usage term do not correlate to the proper scientific meaning for the thread context should not come as any great surprise.

It doesn't matter to those who suffer what the thread meaning means. I mean the word to mean what most people mean it to mean.

 

And none of that provides evidence either for or against any animals having a humanlike experience of suffering.

I prefer to give the benefit of the doubt to those who can suffer .

 

I don't know what sort of experiments you are imagining, but there are not many I can think of where the objective is to deliberately inflict pain, distress, or fear.

 

Perhaps you might give some consideration to arranging a visit to an animal testing lab to see with your own eyes exactly how animals are treated?

I wouldn't have free access to everywhere in a lab or to any lab I chose. I would be shown something that tests how much rabbits like a new type of lettuce.

 

True in itself, but not justification for pre-supposing that at some point in the future a similar situation will unfold for animals, and that therefore your views should be forced onto all the people who will die without medical aid.

I know I can't force my views on others. I can only do my best. I changed. Vivisectors have changed. IRA bombers have changed - well, some of them. So there is hope. I think my original statement was about people's opinion of using other animals. Many people think it is wrong but necessary. Others don't care if it is right or wrong as long as (they believe) it can help them or other humans.

 

That is neither here nor there. We do not level sanctions against everyone in the country because a minority break laws - this is because you cannot judge and convict everyone following the rules based on the actions of those who aren't. To do so is utterly irrational.

I pointed out that there has been widespread corruption. I believe there still is despite some laws that have been introduced recently.

 

That is not the way it works. You make a claim of fact, you post the evidence (or link to it) there and then. Waiting to trip people up is intellectually dishonest, and simply belies a belief-driven agenda.

I am having difficulty in keeping my posts short-ish. I can only do so by not posting lots of quoted evidence or links that no one might follow. I have learnt that people will ask for evidence if they want it. If they don't ask, I usually provide it at a later date.

 

I don't particularly disagree that any of this can or does happen, but unfortunately for you it is not an argument against the conventionally regulated system of animal testing which is in place.

We can't have any faith in the system. When someone involved says that something is necessary we can't know if they believe that, mean that, or just want to protect their interests.

 

I'm sure it will come to you if you think about it. To be honest, you don't have to understand. Only people seeking to enhance their objective viewpoint by reading this thread need to.

From what I understand of 'Godwin's Law', it is said that any debate of this type that goes on long enough will result in the Nazis being brought in. A later addition to the law was that the first person to bring them in, automaticlly loses the debate. I have introduced slavery - the Nazis would have done nicely as an example, too - because the slavers used others for their own ends and cared nothing for the welfare or rights of the slaves. They only cared enough to keep them well enough to work. Comparing slavery or the Nazis to vivisection, slaughter, or factory farms is not inappropriate. Comparing them to a school bully is. In the case of comparison to a school bully, Godwin's Law could be invoked.

 

No, it COULD be cruel in either case. What determines if an act is cruel is not the reason for the act being performed, but the intentions of the person carrying out the act. I suppose you could say it is like the legal concept of mens rea.

 

So, torturing an enemy soldier - or civilian - is not cruel? The torturer is just doing his job. He bears no malice towards his victim. He might even wish he didn't have to use torture. He does it to try to save lives. Someone being sentenced to stoning to death for adultery is not being sentenced out of malice. They are being sentenced because they broke that country's God's law. But it is still cruel.

 

just to quote the oxford english dictionary there, a dictionary that is up to date and often considered the most up-to-date and complete english dictionary. basically meaning if the word/definition isn't in there its not technically english.

 

as PC's definition isn't there(and i can only find that definition on anti animal testing sites) i think its safe to assume that its utter mince and propaganda.

 

not that it matters as we should be using the scientific definition which is clearly defined and cannot change less a few large libraries worth of literature have to be reproduced to cover that mistake.

 

vivesection only applies to operations on live animals. if it doesn't involve cutting them open then it is NOT vivisection.

 

Now, can we PLEASE move on from this unproductive and idiotic arguement as you have been shown to be wrong to exhaustion.

 

If you want to be pedantic you should use vivisection to include operations on people and tatooing. Online dictionaries do use a definition similar to the one I used. As for a word not being English if it doesn't appear in the Oxford dictionary, standard English was originally just an opinion. All forms of British English dialects are as English as any other form. No one invented the language. It developed differently in different parts of the country. The ruling class decided, because it was their opinion, that a certain dialect or modified dialect should be the standard. If things had been different, the standard now could be Glaswegian, Geordie or Liverpudlian.

 

ME- Cambridge University Press.

 

Definition

vivisection

noun

the cutting up or other use of living animals in tests which are intended to increase human knowledge of human diseases and the effects of using particular drugs

 

vivisectionist

noun [C]

a person who is involved in the activity of, or believes in the use of, vivisection

 

http://dictionary.cambridge.org/define.asp?key=88539&dict=CALD

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

 

Merriam-Webster Dictionaries.

 

Main Entry: viv·i·sec·tion

 

Function: noun

Etymology: Latin vivus + English section

Date: 1707

1: the cutting of or operation on a living animal usually for physiological or pathological investigation; broadly : animal experimentation especially if considered to cause distress to the subject

2: minute or pitiless examination or criticism

 

http://www.merriam-webster.com/cgi-bin/dictionary?book=Dictionary&va=vivisection

 

PeacheyCarnehan, I see your "Animal testing doesn't work because most drugs don't work on humans" and raise you a "Gravity doesn't work because hot air balloons don't fall"

 

 

They do eventually when the fire goes out. Or the balloon catches fire.

 

PC. For your own benefit, I would suggest that you stop all this propaganda regarding drug testing and pharmaceutical companies. From what you have posted, it is VERY obvious that you have NEVER spent a day of your life in the pharmaceutical industry and have absolutely no clue what it is like.

 

You've stated that the pharma industry hides data in order to get their drugs out. That is so far from the truth that it could be considered libel. Every regulatory agency on the planet from any country in existance can demand at any point in time to see ALL of the data on a clinical trial. ANY clinical trial. If the company refuses to give them access, the company can be heavily fined and shut down. If it is found that a company falsified data, or threw out pertinent data, those involved in that hiding will go to jail. I work in the industry, and even if I played no part in the hiding of data I could go to jail. If I found out that data was being hidden or falsified, I would go to jail.

 

I'm sure you don't believe that no data has ever been hidden. Individuals and companies in all sectors of business have lied to the police, regulatory bodies and governments. According to the Journal of the American Medical Association, Merck failed to provide data to the FDA which indicated that vioxx caused more deaths amongst Alzheimer patients than other data they did provide.

 

'In December 2001, when the FDA raised safety questions about the submitted safety data, the sponsor did not bring these issues to an institutional review board for review and revealed that there was no data and safety monitoring board for the protocol 078 study.'

JAMA. 2008;299(15):1813-1817

 

And there are many examples of data being withheld from medical journals. There was an agreement between medical journals a few years ago that they would only review studies that had been submitted to the FDA trials database. But that doesn't affect studies from years before, nor is it a requirement of all medical journals.

 

From November 2005 the FDA was supposed to bring an end to conflicts of interest caused by their advisors having financial ties to industry. They had to declare any conflicts of interest. But what's to stop a drug company from simply making the payments under the table so the recipient can claim he or she has no financial ties? Things like this have happened since business was invented.

 

As the Boston Globe said in 2006:

'WASHINGTON -- When a Food and Drug Administration panel of a dozen experts voted to bring back to market the multiple sclerosis drug Tysabri, five had financial ties to the drug's maker, Biogen Idec Inc., or one of its competitors.

 

'The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties.

 

'Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded.

 

'Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.'

Boston Globe, 21st April 2006.

http://www.boston.com/business/healthcare/articles/2006/04/21/no_end_to_fda_disclosure_debate/

 

You also don't seem to understand how the efficacy of a drug is determined in a clinical trial. It isn't determined qualitatively by asking every subject "So, do you think you're feeling better?" The results are determined through lab data (which is quantitative) and ECGs, stress tests, x-rays, ultrasounds, biopsies, etc. ALL test results that are NOT subjective. In addition, the number of subjects taking place in these trials are very large. There are some 5-6 year studies with over 5,000 randomized subjects. That is a LOT of data that can NOT be fudged.[/quote

The following paragraphs are from the New England Journal of Medicine and are taken from their article 'Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy'

 

'Methods We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set.

 

'Results Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

 

'Selective reporting deprives researchers of the accurate data they need to estimate effect size realistically. Inflated effect sizes lead to underestimates of the sample size required to achieve statistical significance. Underpowered studies — and selectively reported studies in general — waste resources and the contributions of investigators and study participants, and they hinder the advancement of medical knowledge. By altering the apparent risk–benefit ratio of drugs, selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health.'

http://content.nejm.org/cgi/content/full/358/3/252

 

 

At the end of a trial, Clinical Study Reports are written and the MASSIVE bulk of those reports are Adverse Event data. The company sponsoring those trials can not withold one single AE regardless of suspected causality.

 

In addition, Clinical Trials are very heavily analyzed before even going into existance. The process of developing a protocol (The specified manner in which the trial has to be carried out and specifics about the subjects that can be included in the trial) takes quite a while. Even then, the protocol has to be approved by every regulatory board in the countries that the study is carried out.

It is only in the last three years that drug firms were required by law to include all details of their trials on websites. Even then, some of them provided the bare minimum of information and even withheld the names of drugs.

 

In the New England Journal of Medicine, Deborah Zarin, the director of the FDA's clinical trials website, said:

'Completion of the Intervention Name field is mandatory for all trials in ClinicalTrials.gov, but the use of specific terms has not been enforced. We determined that three industry data providers — Merck, GlaxoSmithKline, and Pfizer — used a nonspecific term, such as "investigational drug," between 29 percent and 91 percent of the time in trials registered as of May 20, 2005. These three companies are ranked in the top five according to volume of U.S. drug sales.'

Volume 353:2779-2787 December 29, 2005 Number 26

http://content.nejm.org/cgi/content/full/353/26/2779

 

The New York Times online on 23 May 2007, said:

'Recently, a report issued by the Institute of Medicine, a part of the National Academy of Sciences, recommended that the F.D.A. release all summaries of study data it had collected in the process of approving new drugs as well as all post-marketing studies of those products.

 

'The F.D.A. rejected the first recommendation as overly burdensome and Dr. Galson, the director of the F.D.A.’s drug evaluation and research, said that the agency already released much of this information. “It is not that we are philosophically opposed to it, but the work would be enormous,” he said.'

 

They also reported that Deborah Zarin had said: '...reviewing a study’s results to make sure that it was free of any biases interjected by researchers involved in a study or by its sponsor was a major undertaking.'

 

PloS Medicine, on 15th July 2008 (doi:10.1371/journal.pmed.0050160) said:

'As Zarin and Tse have pointed out, FDAAA (FDA Amendments Act of 2007) promotes transparency by outlawing concealment of a trial's existence or results, but does not directly address problems arising from flawed study design, failure to adhere to ethical principles, presentation of fraudulent data, or misrepresentation of actual results. These matters of research quality and interpretation routinely fall to editors and peer reviewers to identify and, when possible, to correct.'

---------

'Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial's registration, generally within a year of the trial's completion, whether or not these results have been published.'

 

The FDAAA comes into force later this month.

 

And PLoS also says:

'In June, members of the World Health Organization's Registry Platform Working Group on the Reporting of Findings of Clinical Trials advanced a position that “the findings of all clinical trials must be made publicly available,” but noted that “Although some journal editors have acknowledged the changing climate around results registration and reporting…they may have a conflict of interest in that they will probably want the key (and potentially most exciting) messages from a trial to appear first, and perhaps exclusively, in their publication”.'

They were referring to Bulletin of the WHO, June 2008, 86 (6)

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

I suspect that the drug companies already have a strategy for concealing what they want to conceal. No law can be completely binding and there are always those who are willing to risk punishment if the rewards are great enough.

 

We have to rely on people like David Graham, Senator Charles Grassley, Representative Henry Waxman and investigative reporters to bring corruption and wrongdoing to our attention. Sometimes, we only learn about unethical or criminal behaviour because reporters or lawyers have gained access to information that was not publically available, or not easily available.

 

 

With regards to the researchers (Investigators as they are properly called) not having access to the data, there's a reason for this. If a doctor is participating in a trial and knows that the drug works or does not work, he/she is more likely to become biased and potentially falsify data.

That's not what I meant.

'The scientists, often from cash-starved university departments, may be prevented from having access to the raw data gathered in the trial which would tell them how well or not the drug worked and whether there were side-effects. They may be given no say in the way the trial is designed and they may have only limited participation in interpreting the results.

"These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavourable to the sponsor's product," says the commentary which will run this week in 12 of the journals. The British Medical Journal is running a separate editorial with the same message.

 

'The editors say that the study produced for publication may be skewed in the interests of the pharmaceutical company....'

 

The Guardian also quotes: 'Where the company controls the trial, the data and the writing of the study, he said, "the research will be presented to favour the product that company makes. I think it happens all the time - certainly in most papers that involve a new drug. It's obvious that that will happen. For the company it is their profit we are talking about. There is a clash of interests". '

Monday September 10, 2001

http://www.guardian.co.uk/uk_news/story/0,3604,549283,00.html

 

Some journals now demand that authors sign a document to say that they have seen the data.

 

However, this is a scientific community and beliefs won't win you any arguments. Coming into a debate with heresay and beliefs will not sway anybody's beliefs or win any debates. It is a massive shame when someone learns a little bit about something and believes they are an expert on the subject which you appear to be.

I have already shown a small part of the evidence that the rules can be and are being broken and that the transgressors are not always adequately punished if at all.

 

Please document all that. Wait a minute. Are you referring to the physicians in double-blind studies? As Jdurg noted, they cannot have access while the trial is underway. They cannot know which patients are getting treatment and which are controls. Such knowledge could bias how they evaluated the patients. AFTER the trial is over, I don't know of a single case where the physicians/researchers don't have access to the data. They are required by both law and custom.

Quote: 'Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.

 

'Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.'

JAMA. 2008;299(15):1800-1812.

 

 

 

PC, you are slipping between 3 different claims:

1. Animal studies themselves are immmoral

2. There are NO safeguards for animals.

3. There are abused of the existing safeguards on animals.

 

You are trying to use examples of #3 to argue for #1. But that doesn't work. Let's take this out of animal testing. As you noted, there are occasional abuses of children in orphanages and the elderly in nursing homes. In both cases there are safeguards in place. However, even tho there is the occasional abuse it does not follow that it is immoral to have children in orphanages or the elderly in nursing homes!

1. I do say that cruel experiments are immoral.

2. There are no effective safeguards. The safeguards in place can be and have been ignored.

3. There are abuses of the rules.

 

It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims.

 

Which is why all such funding must be disclosed! ALL funding for papers must now be disclosed so any possible conflict of interest (which is what you are talking about) is done. However, you do realize that a lot of your complaints applies to CLINICAL TRIALS, and you approve of those. You can't be internally consistent and say that these claims mean that we must stop animal trials but it is OK to continue doing human clinical trials! Can't have it both ways.

 

Which shows that you are simply rationalizing a prior belief, not trying to objectively analyze a situation ethically and reach a objective ethical conclusion. So, since all this is rationalizing an a priori belief, I'll ask you again: why should we believe anything you say? Why would you not say anything -- true or not -- to rationalize your belief?

I'm not being paid thousands of pounds to look favourably on the products of a certain company. I am not conducting research which will benefit my paymasters. As I have said, rules and laws can be broken. Many believe that recent laws demanding transparency in cases of potential conflicts of interest will not work if there is a desire to get round them. My reason for pointing out all this potential corruption is to show that there can be tremendous incentive to show drugs as safer or more efficacious then they might be.

 

But animal models do simulate reliably. All the drugs and treatments on the market, and all the drugs and treatements witheld from clinical trials attest to that. Clinical trials are done because we insist on double-checking the results from animals.

 

But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans.

 

The first and second, as Jdurg has pointed out, are illegal. Usually there is room about potential danger for reasonable people to reasonably disagree. That was certainly the case with Viox and, before that, chloramphenicol. Deciding how "bad" the danger is becomes a question of ethics, not science. What level of risk are we willing to accept? That changes, of course, depending on the situation and the consequences.

 

As for vioxx - merck produced seminars for physicians where they were given information which misrepresented the known safety and, I think, efficacy data of vioxx. Their presentations minimised the potentially serious side effects of the drug and made unsubstantiated claims about its superiority. The FDA sent a warning letter to the company to tell them to stop. Physicians could have been mislead into thinking vioxx was safer than the data from trials indicated. Merck also gave their sales people training and prompt cards to handle any concerns from physicians over safety. There are many cases where drug companies have hidden data. They are legally obliged to provide all data to the FDA in the US but they have withheld data from medical journals. Recent decisions by journal editors are supposed to make this impossible now. Supposed to. Laws are supposed to stop criminals.

 

But look at all those "ifs". You didn't have those qualifiers in your original idea! Instead, you thought drugs that were toxic in animals should be tested on humans. But no, you won't volunteer. You won't volunteer, for instance, to test a new NSAID for headaches that previously was toxic in rats, for instance. Would you?

 

I didn't say that drugs should be first tested in humans. This should only happen after all the other non-cruel experimental methods have been used. And then the first trial in humans should be a microdose that is much less than the usual one-hundredth. I haven't had so much as an aspirin since I was aged about 14. Why should I start now? Those who need drugs should usually be the ones to test them - after exhaustive safety testing has been done.

 

But very little money is spent on developing these other methods. Just a few days ago the US government promised to bail out two large mortgage lenders. They are willing to pay out thousands of millions of dollars. People's property and the housing market are very important but so is health. Not enough money is being spent.

 

Euthanasia is the correct term. Just as you insist that "vivisection" is the correct term. In your case, you want to most emotional impact even if it is incorrect. Are you afraid to use the correct term "animal testing" because it would not make animal research look so bad? Sauce for the goose.

Would you say that 'euthanasia is used in place of an emotional word? 'Animal testing' is wrong because it doesn't give a sense of the wrongness of it. The animals don't and can't volunteer. It is as wrong as testing on humans against their will. And, as we are all animals, it doesn't differentiate between human animals and other animals.

 

No, you were talking about testing. Since the original testing was raondomized double blind, we know ahead of time whatever placebo effect there is. We know the real effect before they get to market.

 

It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.

 

Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.

I don't know what you are trying to say here. As I said, in the clinical trials many or most of the people will hope or think they are on the drug. That will give whatever it is a boost. After a drug has been approved, it is invested with a certain power. The more it is hyped, the more powerful it becomes. The drug companies have been caught out playing up their new drugs and there have been many cases where the FDA has had to warn them to tone down their advertising.

+++++++++++++++++++++++

This always happens in these debates. Someone says something. Someone else refers to part of what they said, taking it out of context. The original person, if they are not careful, replies to that without realising what they originally said and, within four or five posts, is saying that black is white.

 

Here is how the comments about placebos started:

 

I said, in reply to someone's comment that there are lots of drugs that have saved people's lives: ' Claims that a certain drug has saved someone's life might just be claims in some cases. How do we know the drug alone did it? It might have been the placebo effect of the drug that did it. Placebos have a placebo effect. A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect - especially if the drug companies put out misleading advertising about it. It might have been the result of the person just getting better - as sometimes happens. It might have been a combination of factors. How do we know that the drug, or an even better one, couldn't have been developed without vivisection?

 

Then you qouted part of that: 'Placebos have a placebo effect.' And you replied by saying: 'That's why clinical trials are designed in such a way as to eliminate the placebo effect. Haven't you ever heard about "randomized double blind" studies? Phase II clinical trials are all randomized double blind.'

 

To which I replied: 'I was referring to drugs already on the market. Some drugs, quite often due to marketing hype, are thought to be miracle drugs. These drugs might work, or work better than they would, because people - patients and medical staff - believe the hype.

 

'But even in clinical trials which are double-blinded and Random-Housed the placebo effect is impossible to eliminate. Many, or most or even all, in the trials will hope and/or assume they are being given the drug rather than the placebo. That will make whatever they take work better. The drug might even have a slight therapeutic effect. That will be maginified by its own placebo effect.'

 

And then you said: 'It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.'

 

And also: 'Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.'

 

And: 'Sigh. PC, you are making lots of Arguments from Ignorance. This is one of them. If ALL the patients think they are getting the drug but only half are, then what the placebo effect is going to do is make it look like the drug has no therapeutic effect because the controls will also do better. This will eliminate the difference between those that take the drug and those that don't. THINK ABOUT IT! The effect of a double-blind trial will be exactly opposite of what you think.'

 

ME, NOW: - I was saying that drugs already on the market could have a placebo effect and cures ascribed to their therapeutic action might not be entirely - or at all - due to it. I also know what 'randomised' and 'double tightened' mean. My use of 'Random House' was a joke. And now you have ruined the much funnier joke I was going to tell in relation to this. It would have had people howling with laughter and rolling on the floor.

 

that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.

Again, all this quoting can lead to confusion. I originally referred to computers in reply to what Cap'n Refsmmat said. He or she said:

''To program the computer, you need to know a heck of a lot about the animals that we don't know, and that means, yes: DISSECTING THEM!!!!!! Really, we don't know about every compound an cell in animals and humans, it would take an insane amount of research before we did.'

 

I replied by saying: 'Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans.'

 

To which you posted: '1. Because of evolution, knowing about other animals does help us know about humans. We are related to other mammals by descent with modification.

2. And that part of research "not applicable to humans" is part of the falsification I talked about above. That is the part we are certain about. However, we wouldn't know it was not applicable to humans unless we had done it first.'

 

Aaaaand then, still talking about computers, I said: 'The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes.'

 

To which you replied: 'that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.'

 

And now I say: 'Again, all this quoting can lead to confusion. I originally....' and so on.

 

Jdurg and I have both given lots of reasons why drugs "fail" clinical trials that have nothing to do with the failure of animal testing. You must address those reasons and show they are incorrect.

I know that drugs can fail for commercial reasons. I've referred to that before.

 

But it's IACUCS that are necessary for the preliminary animal testing! If they don't have conflicts of interest or corrupt members, then your whole first sentence is invalid! IACUCs ensure the rules are followed, and if they are not corrupt, then it doesn't matter what the "powerful backers" want. Look at one example. The ONLY way human embryonic stem cell research was done was by avoiding the law/legislation/rules and going where they don't apply!

I said that I have no evidence for IACUC conflicts of interest. But, as other regulatory bodies have been proven to have such conflicts, it's not unlikely that they can be found in IACUCs. IACUCs have shown negligence and incompetence. Were they really incompetent or were they nobbled? If they can be so incompetent, it doesn't say much for their ability to do the job they are supposed to do.

 

All you have to do is a superficial PubMed search on ANY disease and drug to refute that "paucity of reliable, accurate results" claim. ALL the currently used treatments, and the ones that never made it to humans, went thru animal testing. All you have to do is go LOOK at the evidenced and not be deafened by the vile din of animal rights propaganda. See?, this name calling works both ways, doesn't it? So how about you just stop that and LOOK AT THE DATA. Scientific data is PUBLISHED. It's available to everyone.

 

I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans.

 

On that off chance is why we go thru phased clinical trials! I've said this before PC, please pay attention. No one claims that animal testing is 100% reliable. Nothing in biology is. There are variations -- between individuals and between species. But animal testing is reliable enough as to be essential.

If it doesn't begin to approach being very reliable then what is the point of it? It's not 100% reliable. How reliable is it? 50%? More? Less? Most drugs that go through cruel testing don't manage to wangle their way through human testing. They are found wanting. And what they are wanting is proper medical research.

 

Look, if you had done the testing on Viox or thalidomide your way, they still would have caused harm to humans! You would not have tested thalidomide initially on pregnant women and thus would not have known about the teratogenic effects until lots of people used it. Viox is harmful only to a small portion of humans, so again human testing would have missed it (and did, as a matter of fact). Now, because there are going to be some times when the drug is not obviously harmful to a person, do we stop developing new drugs?

It was known decades earlier that substances could cross the placenta. Which species could they have used to check for teratogenicity? Which species would they have believed? If they'd never tested for it before, how would they have known which species was supposed to be a model?

 

What we are saying is that animal testing reduces those examples of harm to humans to a very few. If we went directly to human testing, we would have a LOT more dead people around. YOU already indicated that you won't volunteer. So, how can you be so hypocritical to want other people to take the risks you refuse to?

See above. I have never said that a new drug should just be given to people without proper testing.

 

 

 

 

"PharmaPendium puts drug safety data of US-approved drugs at a researcher's fingertips. It lets researchers understand the full scope of projected risks early in the drug development process.

 

For this disuscussion, notice that you can follow a drug from animal testing (preclinical) to clinical to post-market for both efficacy and safety. This will dispel the animal-rights myth that animal tests have no reliability for humans.

As I have said, a drug that gets through clinical testing will have a clear record going back to the preclinical stages. That is why it was approved. It it had behaved differently in humans to how it had behaved in non-humans, it wouldn't have been approved. Then you wouldn't be able to trace its success back to the preclinical stages - because it wasn't successful. Only a small number of drugs are approved. The majority that go into clinical trials aren't approved.

 

Please document all that. Wait a minute. Are you referring to the physicians in double-blind studies? As Jdurg noted, they cannot have access while the trial is underway. They cannot know which patients are getting treatment and which are controls. Such knowledge could bias how they evaluated the patients. AFTER the trial is over, I don't know of a single case where the physicians/researchers don't have access to the data. They are required by both law and custom.

Quote: 'Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.

 

'Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.'

JAMA. 2008;299(15):1800-1812.

 

 

 

PC, you are slipping between 3 different claims:

1. Animal studies themselves are immmoral

2. There are NO safeguards for animals.

3. There are abused of the existing safeguards on animals.

 

You are trying to use examples of #3 to argue for #1. But that doesn't work. Let's take this out of animal testing. As you noted, there are occasional abuses of children in orphanages and the elderly in nursing homes. In both cases there are safeguards in place. However, even tho there is the occasional abuse it does not follow that it is immoral to have children in orphanages or the elderly in nursing homes!

1. I do say that cruel experiments are immoral.

2. There are no effective safeguards. The safeguards in place can be and have been ignored.

3. There are abuses of the rules.

 

It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims.

 

Which is why all such funding must be disclosed! ALL funding for papers must now be disclosed so any possible conflict of interest (which is what you are talking about) is done. However, you do realize that a lot of your complaints applies to CLINICAL TRIALS, and you approve of those. You can't be internally consistent and say that these claims mean that we must stop animal trials but it is OK to continue doing human clinical trials! Can't have it both ways.

 

Which shows that you are simply rationalizing a prior belief, not trying to objectively analyze a situation ethically and reach a objective ethical conclusion. So, since all this is rationalizing an a priori belief, I'll ask you again: why should we believe anything you say? Why would you not say anything -- true or not -- to rationalize your belief?

I'm not being paid thousands of pounds to look favourably on the products of a certain company. I am not conducting research which will benefit my paymasters. As I have said, rules and laws can be broken. Many believe that recent laws demanding transparency in cases of potential conflicts of interest will not work if there is a desire to get round them. My reason for pointing out all this potential corruption is to show that there can be tremendous incentive to show drugs as safer or more efficacious then they might be.

 

But animal models do simulate reliably. All the drugs and treatments on the market, and all the drugs and treatements witheld from clinical trials attest to that. Clinical trials are done because we insist on double-checking the results from animals.

 

But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans.

 

The first and second, as Jdurg has pointed out, are illegal. Usually there is room about potential danger for reasonable people to reasonably disagree. That was certainly the case with Viox and, before that, chloramphenicol. Deciding how "bad" the danger is becomes a question of ethics, not science. What level of risk are we willing to accept? That changes, of course, depending on the situation and the consequences.

 

As for vioxx - merck produced seminars for physicians where they were given information which misrepresented the known safety and, I think, efficacy data of vioxx. Their presentations minimised the potentially serious side effects of the drug and made unsubstantiated claims about its superiority. The FDA sent a warning letter to the company to tell them to stop. Physicians could have been mislead into thinking vioxx was safer than the data from trials indicated. Merck also gave their sales people training and prompt cards to handle any concerns from physicians over safety. There are many cases where drug companies have hidden data. They are legally obliged to provide all data to the FDA in the US but they have withheld data from medical journals. Recent decisions by journal editors are supposed to make this impossible now. Supposed to. Laws are supposed to stop criminals.

 

But look at all those "ifs". You didn't have those qualifiers in your original idea! Instead, you thought drugs that were toxic in animals should be tested on humans. But no, you won't volunteer. You won't volunteer, for instance, to test a new NSAID for headaches that previously was toxic in rats, for instance. Would you?

 

I didn't say that drugs should be first tested in humans. This should only happen after all the other non-cruel experimental methods have been used. And then the first trial in humans should be a microdose that is much less than the usual one-hundredth. I haven't had so much as an aspirin since I was aged about 14. Why should I start now? Those who need drugs should usually be the ones to test them - after exhaustive safety testing has been done.

 

But very little money is spent on developing these other methods. Just a few days ago the US government promised to bail out two large mortgage lenders. They are willing to pay out thousands of millions of dollars. People's property and the housing market are very important but so is health. Not enough money is being spent.

 

Euthanasia is the correct term. Just as you insist that "vivisection" is the correct term. In your case, you want to most emotional impact even if it is incorrect. Are you afraid to use the correct term "animal testing" because it would not make animal research look so bad? Sauce for the goose.

Would you say that 'euthanasia is used in place of an emotional word? 'Animal testing' is wrong because it doesn't give a sense of the wrongness of it. The animals don't and can't volunteer. It is as wrong as testing on humans against their will. And, as we are all animals, it doesn't differentiate between human animals and other animals.

 

No, you were talking about testing. Since the original testing was raondomized double blind, we know ahead of time whatever placebo effect there is. We know the real effect before they get to market.

 

It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.

 

Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.

I don't know what you are trying to say here. As I said, in the clinical trials many or most of the people will hope or think they are on the drug. That will give whatever it is a boost. After a drug has been approved, it is invested with a certain power. The more it is hyped, the more powerful it becomes. The drug companies have been caught out playing up their new drugs and there have been many cases where the FDA has had to warn them to tone down their advertising.

+++++++++++++++++++++++

This always happens in these debates. Someone says something. Someone else refers to part of what they said, taking it out of context. The original person, if they are not careful, replies to that without realising what they originally said and, within four or five posts, is saying that black is white.

 

Here is how the comments about placebos started:

 

I said, in reply to someone's comment that there are lots of drugs that have saved people's lives: ' Claims that a certain drug has saved someone's life might just be claims in some cases. How do we know the drug alone did it? It might have been the placebo effect of the drug that did it. Placebos have a placebo effect. A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect - especially if the drug companies put out misleading advertising about it. It might have been the result of the person just getting better - as sometimes happens. It might have been a combination of factors. How do we know that the drug, or an even better one, couldn't have been developed without vivisection?

 

Then you qouted part of that: 'Placebos have a placebo effect.' And you replied by saying: 'That's why clinical trials are designed in such a way as to eliminate the placebo effect. Haven't you ever heard about "randomized double blind" studies? Phase II clinical trials are all randomized double blind.'

 

To which I replied: 'I was referring to drugs already on the market. Some drugs, quite often due to marketing hype, are thought to be miracle drugs. These drugs might work, or work better than they would, because people - patients and medical staff - believe the hype.

 

'But even in clinical trials which are double-blinded and Random-Housed the placebo effect is impossible to eliminate. Many, or most or even all, in the trials will hope and/or assume they are being given the drug rather than the placebo. That will make whatever they take work better. The drug might even have a slight therapeutic effect. That will be maginified by its own placebo effect.'

 

And then you said: 'It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.'

 

And also: 'Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.'

 

And: 'Sigh. PC, you are making lots of Arguments from Ignorance. This is one of them. If ALL the patients think they are getting the drug but only half are, then what the placebo effect is going to do is make it look like the drug has no therapeutic effect because the controls will also do better. This will eliminate the difference between those that take the drug and those that don't. THINK ABOUT IT! The effect of a double-blind trial will be exactly opposite of what you think.'

 

ME, NOW: - I was saying that drugs already on the market could have a placebo effect and cures ascribed to their therapeutic action might not be entirely - or at all - due to it. I also know what 'randomised' and 'double tightened' mean. My use of 'Random House' was a joke. And now you have ruined the much funnier joke I was going to tell in relation to this. It would have had people howling with laughter and rolling on the floor.

 

that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.

Again, all this quoting can lead to confusion. I originally referred to computers in reply to what Cap'n Refsmmat said. He or she said:

''To program the computer, you need to know a heck of a lot about the animals that we don't know, and that means, yes: DISSECTING THEM!!!!!! Really, we don't know about every compound an cell in animals and humans, it would take an insane amount of research before we did.'

 

I replied by saying: 'Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans.'

 

To which you posted: '1. Because of evolution, knowing about other animals does help us know about humans. We are related to other mammals by descent with modification.

2. And that part of research "not applicable to humans" is part of the falsification I talked about above. That is the part we are certain about. However, we wouldn't know it was not applicable to humans unless we had done it first.'

 

Aaaaand then, still talking about computers, I said: 'The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes.'

 

To which you replied: 'that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.'

 

And now I say: 'Again, all this quoting can lead to confusion. I originally....' and so on.

 

Jdurg and I have both given lots of reasons why drugs "fail" clinical trials that have nothing to do with the failure of animal testing. You must address those reasons and show they are incorrect.

I know that drugs can fail for commercial reasons. I've referred to that before.

 

But it's IACUCS that are necessary for the preliminary animal testing! If they don't have conflicts of interest or corrupt members, then your whole first sentence is invalid! IACUCs ensure the rules are followed, and if they are not corrupt, then it doesn't matter what the "powerful backers" want. Look at one example. The ONLY way human embryonic stem cell research was done was by avoiding the law/legislation/rules and going where they don't apply!

I said that I have no evidence for IACUC conflicts of interest. But, as other regulatory bodies have been proven to have such conflicts, it's not unlikely that they can be found in IACUCs. IACUCs have shown negligence and incompetence. Were they really incompetent or were they nobbled? If they can be so incompetent, it doesn't say much for their ability to do the job they are supposed to do.

 

All you have to do is a superficial PubMed search on ANY disease and drug to refute that "paucity of reliable, accurate results" claim. ALL the currently used treatments, and the ones that never made it to humans, went thru animal testing. All you have to do is go LOOK at the evidenced and not be deafened by the vile din of animal rights propaganda. See?, this name calling works both ways, doesn't it? So how about you just stop that and LOOK AT THE DATA. Scientific data is PUBLISHED. It's available to everyone.

 

I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans.

 

On that off chance is why we go thru phased clinical trials! I've said this before PC, please pay attention. No one claims that animal testing is 100% reliable. Nothing in biology is. There are variations -- between individuals and between species. But animal testing is reliable enough as to be essential.

If it doesn't begin to approach being very reliable then what is the point of it? It's not 100% reliable. How reliable is it? 50%? More? Less? Most drugs that go through cruel testing don't manage to wangle their way through human testing. They are found wanting. And what they are wanting is proper medical research.

 

Look, if you had done the testing on Viox or thalidomide your way, they still would have caused harm to humans! You would not have tested thalidomide initially on pregnant women and thus would not have known about the teratogenic effects until lots of people used it. Viox is harmful only to a small portion of humans, so again human testing would have missed it (and did, as a matter of fact). Now, because there are going to be some times when the drug is not obviously harmful to a person, do we stop developing new drugs?

It was known decades earlier that substances could cross the placenta. Which species could they have used to check for teratogenicity? Which species would they have believed? If they'd never tested for it before, how would they have known which species was supposed to be a model?

 

What we are saying is that animal testing reduces those examples of harm to humans to a very few. If we went directly to human testing, we would have a LOT more dead people around. YOU already indicated that you won't volunteer. So, how can you be so hypocritical to want other people to take the risks you refuse to?

See above. I have never said that a new drug should just be given to people without proper testing.

 

 

 

 

"PharmaPendium puts drug safety data of US-approved drugs at a researcher's fingertips. It lets researchers understand the full scope of projected risks early in the drug development process.

 

For this disuscussion, notice that you can follow a drug from animal testing (preclinical) to clinical to post-market for both efficacy and safety. This will dispel the animal-rights myth that animal tests have no reliability for humans.

As I have said, a drug that gets through clinical testing will have a clear record going back to the preclinical stages. That is why it was approved. It it had behaved differently in humans to how it had behaved in non-humans, it wouldn't have been approved. Then you wouldn't be able to trace its success back to the preclinical stages - because it wasn't successful. Only a small number of drugs are approved. The majority that go into clinical trials aren't approved.

[iNow]

Your post contains far too many inaccuracies to be taken seriously.

Edited September 14, 2008 by iNow

[Cap'n Refsmmat]

I'm not sure such a response deserves the user title "Scientist".

[iNow]

Corrected.

[Mr Skeptic]

I smell a new contender for "longest post"! Or perhaps we should get Edtharan to answer that post line by line? >>

[halogirl]

I understand, and I also know where you're coming from. Just to be clear, though, there is no objective line between right and wrong, good and evil. All we have are our subjective and personal interpretations.

 

I personally would not be alive today were it not for medical knowledge obtained through tests with animals, so I am both biased and grateful to the little beings who were involved, and these animals will always have my gratitude and support. I just ask that we be realistic and understand that complex issues like this have many shades of gray, and these shades warrant open discussion and responsible understanding.

 

 

 

you are of course right, it does depend on perception, like i said it is necessary, and i am glad that you are alive, i was merely stating that i feel it is morally wrong to intrude on another being in that fashion, if that being is unwilling.

[jdurg]

PC, I really don't appreciate you calling me a "minion". Your statement that "Drug companies and their minions" when do whatever they can to sell their drug is insulting, and rude. Again, show me that you have worked in the pharma industry and you know everything about the industry.

 

If you so strongly feel that animal testing is wrong then don't EVER take a medication, don't EVER go to an ER when you are severely ill, and don't EVER take any drug to ease a life threatening condition.

 

Better yet, make it your life's goal to shut down every pharmaceutical company on earth and then you can take the responsibility for the death and loss of well being for the millions of people that these "Evil Corporations" provide life and happiness for.

 

Yes, the corporations do have profit in their mind with what they do. This "profit", however, is what pays for every single worker in that company from the custodians, to the security guards, to the people like me who work our asses off on these trials. I am NOT going to work for free which is what many people, yourself included, seem to want.

[SH3RL0CK]

PC,

 

If this were to be graded in a debate class, I am sorry to say that you would have failed. Granted, I am not a debate teacher, but it is clear to me which side is best supported, most logical, and most reasonable. Don't take this as a personal attack (it isn't meant to be - I am actually trying to help you here) but you have done nothing to bring me to your position. Consider the following:

 

1) A severe lack of supporting documentation. And even the few links you have provided don't back up your statements well. Those presenting the other side of the arguement, on the other hand, have provided a great number of excellent references which strongly support their position.

 

It is fine to argue without references on the basis of logic, but this becomes weak if the other position is supported by good references...as is the case in this thread.

 

2) You do not stay on topic. As I understand it, your position is that this testing is both unnecessary and ethically wrong. But rather than back up this position, you seem to be spending time and effort in discrediting the other position. If you really had a valid point, you could defend your position and even use your opponents references to support your claims.

 

3) Your posts are exceedingly long...so much so that I do not have time to read them. As such, if you had done #1 and #2 above (which as far as I can tell you have NOT), I might have missed it. In fact, I am beginning to think you don't have a point and are instead trying to make up with quantity your lack of quality.

 

Mostly because of the time required, but also because it seems to me this thread isn't a productive debate (only one side is reasonable, logical, supported by science, etc.) I really don't want to read anymore.

[Livingstone]

Guys lets get back to the debate shall we? In our last years ethical debate, there was a long shot at the question.

 

To be honest, i was first for the *right*, then i snapped to the *wrong*, then after getting hits from all sides, i became undecided and virtually lost, just like some people round here, and the tendencies, when you caught between what you think is morally right to you and what is right to the rest of societies, you begin to blame everyone. Blame the pharmacist for killing all our animals, blame failed drugs for having been tested on animals and not men. For one moment we wish there was a mid point between the extremities of the right or wrong question.

 

So rather than the right or wrong (black or white) nature of this debate, lets concentrate on when and how the use of animals is justified in research, and how we could avoid the waste and failures of the past! In some countries you have the 3Rs theory, which generally applies to all.

 

Another thing not to forget in this case, is that no one teaches us what we percieve as right or wrong, this is a combination of sevral influences, from religion, background, morals, etc, so what might be right for a you might not be right for me! and the sad thing is that ethical debates, usually deviate from discussing the morals of an issue and their justification to seeking a universal law or legal clause which frankly can NEVER be achieved, so guys if some one could reask this question, it probably can help the debate!

[riotgrrl_94]

If you think animal testing is just " no big deal", then how bout you let me lock you in a cage,and make you puff till you puke.

If you think animals have no "intellect", then how about we test your ****ing intellect, swank.

You think because they don't speak, they don't have intellect?

Your one to know right? Because you know what they're ****ing thinking, you know what the **** this world is all about right? You think something with basic ****ing survival skills should be used for our ****ing pleasure. You can shove animal testing up your ****in' ass for all I care. But you won't ****ing use an animal as an experiment to test your ****ing "needs". You want your makeup so badly, ****ing test it on yourself. bitch.

[iNow]

A logical and well supported argument from you, first time poster riotgrrl_94, but I remain unconvinced by your vitriol, which itself strikes me as misplaced and uninformed.

[Pangloss]

It is a big deal, they do have varying degrees of intelligence, and it's not about makeup. I wouldn't have a problem with banning testing for makeup products. But the same ridicule applied two posts above could just as readily be applied to animal rights advocates. That doesn't constitute an argument.

 

This issue is a non-starter, relegated to extremists and crackpots. It doesn't fail to get taken seriously because people want their hair care products and don't care about animals, it fails to be taken seriously because of the obvious human health benefits and because the care issue isn't actually that serious, especially when compared with the beef industry or other problems faced by society.

 

In short, we have bigger fish to fry. So to speak.

[Sayonara]

Those are all very good points.

[lucaspa]

The statements below are from FDA documents or communications written in 2006 that are talking about improving the drug development process:

 

'Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.'

http://www.fda.gov/bbs/topics/news/2006/NEW01296.html

 

You need to read the whole page. This isn't saying that animal testing is faulty, but rather that human testing is faulty. Basically, what they are saying is that researchers don't have to adhere to the rules of manufacture needed for distribution to the public:

" “The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution," said Janet Woodcock, MD, FDA Deputy Commissioner for Operations. "These requirements are so burdensome for early phase 1 studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories. Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies." "

 

So, the article doesn't support your claim.

 

The system doesn't work, unless you mean that getting a minority of drugs through clinical trials so they are approved, is proof that it is working.

 

Yes, it does. Remember, the prime criteria for a drug is safety. Not efficacy. The rules are skewed toward safety. I, personally, don't like the new rule because they are now being skewed toward the profits of the drug companies. Under the new rules, we are likely to get more situations like Vioxx where there are low level safety threats that are not caught.

 

The lab animal data, they think, tells them the drugs have a good chance of doing so. It's not the only data, as there are many other methods, but as people here have said, if in silico indicates a drug is safe but rats indicate it's not, then it's goodbye drug. The lab animal data, being in living organisms, is what they place so much reliance upon - it must be if it overrides the results of in silico or any other pre-clinical testing. And that reliance is misplaced. Most new drugs fail in the clinical testing on humans.

 

You're logic here is illogical. You seem to be saying that we would have greater success in humans if we ignored the animal data that says a drug is unsafe in humans. That's silly. If we just take the in silico data and go directly to humans, it means that, instead of 1 in 10 that pass clinical trials, it would be 1 in 100 or 1 in 1,000.

 

Also, the drug companies and their minions do need to find a reason. ...

 

This has nothing to do with the value of animal testing. If you skip animal testing it means that the drug companies would have 10 times the number of drugs to try to promote by means that you say are immoral.

 

Even if we use the term 'lab animal experiments' those animals possess health and life. It is wrong to take those away from them. It is wrong to use them in painful or potentially painful ways that don't benefit them.

 

Why? Is it wrong for a lion to deprive a zebra of health and life? Is it wrong for us to deprive a corn plant of health and life? PC, you keep ignoring that EVERY animal species must deprive another living organism of "health and life". If it is absolutely wrong to do so, then humans must starve themselves to death. You must forgo all future meals because each of them is going to involve depriving some organism of "health and life". Even if you confine yourself to dairy and eggs, how dare you cage animals so you can milk them or gather their eggs?

 

There is no universal, immutable law that says one thing is right and another thing is wrong. It is all opinion.

 

Really? NO way at all to determine whether something is right or wrong? You've never taken an ethics course, have you? Let's go to murder. Is murder ever "right"? I don't mean killing, I mean murder: killing for one's personal gain.

 

The reason the debate about abortion. Some people consider it murder and some don't. But, if it is murder then it is wrong.

 

I prefer to give the benefit of the doubt to those who can suffer .

 

Then why do you still go on eating? You don't give the benefit to those who suffered and died to provide that food, do you?

 

I wouldn't have free access to everywhere in a lab or to any lab I chose. I would be shown something that tests how much rabbits like a new type of lettuce.

 

How do you know? Have you tried?

 

I pointed out that there has been widespread corruption. I believe there still is despite some laws that have been introduced recently.

 

First, what you have pointed to are isolated incidents of corruption. How many drugs are on the market? How many have had to be pulled like Vioxx? Do the math. You need over 50% before you can say "widespread".

 

Second, you contradict yourself with this statement: "I said that I have no evidence for IACUC conflicts of interest." So no evidence for corruption one the point that we are discussing here, namely, whether animal studies are conducted according to the regulations to minimize pain and suffering to the animals.

 

When someone involved says that something is necessary we can't know if they believe that, mean that, or just want to protect their interests.

 

This is science. We can independently check it.

So, torturing an enemy soldier - or civilian - is not cruel?

 

Moral standard apply within a species. It is how we treat other members of our own species. I've already demonstrated why we cannot export absolute morals to our relationship with other species.

 

As it happens, I agree with you that "torture" of animals is wrong. By "torture" I mean here giving pain for personal pleasure. As you noted, we as a society have decided that we can lock people up or subject them to stress or pain if it is for the good of others. Are you advocating that we let all people in prison go? Why not? Aren't they locked up as you say animals in animal testing are? Do you want the child molesters and rapist back out on the street? Why not?

 

I submit that it is moral to involuntarily lock up human beings for the good of others. If so, then we can "lock up" animals for the good of human beings.

 

I'm sure you don't believe that no data has ever been hidden. Individuals and companies in all sectors of business have lied to the police, regulatory bodies and governments. According to the Journal of the American Medical Association, Merck failed to provide data to the FDA which indicated that vioxx caused more deaths amongst Alzheimer patients than other data they did provide.

 

But was Merck required to provide the data? YES! What you have is criminal wrongdoing by people within a drug company. As I asked, do we shut down all nursing homes or orphanages because of criminal wrongdoing by a few? You never answered that.

 

And there are many examples of data being withheld from medical journals. There was an agreement between medical journals a few years ago that they would only review studies that had been submitted to the FDA trials database. But that doesn't affect studies from years before, nor is it a requirement of all medical journals.

 

Of course we can't go back retrospectively. Again, what you are talking about is closing the loopholes in a system. That is not an argument that animal testing should not be done. It's only a comment that we weren't policing the industry better.

 

And notice, this problem is only going to increase if you allow drug companies to skip animal testing.

 

The following paragraphs are from the New England Journal of Medicine and are taken from their article 'Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy'

 

I was saying that the data could not be hidden, not that it wasn't published. In science, most studies with negative data are never published. The FDA had ALL the data when they approved the drug. This isn't about data being hidden, it is a complaint that doctors should have all the data at their fingertips " By altering the apparent risk–benefit ratio of drugs, selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health.' "

 

Now that all the FDA data is on the web and can be accessed by physicians, this problem disappears.

 

That's not what I meant.

'The scientists, often from cash-starved university departments, may be prevented from having access to the raw data gathered in the trial which would tell them how well or not the drug worked and whether there were side-effects.

 

This may happen in Britain, but I know from personal experience that US medical schools and universities put in clauses in the contracts that specify 1) access to all data and 2) the right to publish.

 

Some journals now demand that authors sign a document to say that they have seen the data.

 

All journals now require a statement that all authors take complete ownership of all the data in the paper.

 

I have already shown a small part of the evidence that the rules can be and are being broken and that the transgressors are not always adequately punished if at all.

 

That is a separate issue from whether animal testing is right or wrong, isn't it?

 

1. I do say that cruel experiments are immoral.

 

I agree. But we disagree on what is "cruel".

 

2. There are no effective safeguards. The safeguards in place can be and have been ignored.

 

You haven't demonstrated that for animal studies. In fact, you haven't even demonstrated that safeguards for human studies are ineffective or are ignored. What you have demonstrated, at most, is that false report ing has happened. NONE of your sources ever said that the safeguards for the human subjects were not effective or were ignored.

 

3. There are abuses of the rules.

 

You haven't demonstrated that for animal studies. Again, you haven't demonstrated that the rules for safeguarding human subjects were abused. All your examples are about abuses of the rules for reporting data.

 

 

But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans.

 

You logic is a bit hard to follow here. You are arguing simultaneously that animal testing failed to pick up drugs that were harmful to humans. Therefore, you logic goes, all the drugs that were harmful in animals should be OK in humans and therefore we should go to clinical trials.

 

If 9 in 10 drugs that were not harmful in animals turned out to have insufficient safety for humans, why would you think that the drugs that were not harmful in animals would not have at least the same ratio?

 

With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans.

 

Similar is not the same as "identical". You don't place much morality on causing harm to your fellow humans, do you? If you think it immoral to cause pain and suffering on animals, why are you so eager to put humans at risk for pain and suffering? We check to avoid any possibility of pain and suffering to humans.

 

I didn't say that drugs should be first tested in humans.

 

Yes, you did. I quoted you.

 

 

And what good does that do? That could give you very misleading results because you haven't reached the toxic threshold. Remember that therapeutic index I talked about? If the index is 1:100 you won't detect anything at the microdose, but you will kill the person at a full dose.

 

I haven't had so much as an aspirin since I was aged about 14. Why should I start now? Those who need drugs should usually be the ones to test them - after exhaustive safety testing has been done.

 

Ah, so another reason for you not to volunteer! But rememmber, you are using humans for the "exhaustive safety testing"! It's animals that are the first line of exhaustive safety testing and you want to eliminate that.

 

But very little money is spent on developing these other methods. ... Not enough money is being spent.

 

That's a different argument. Your innitial claim was that NO money or effort was being devoted. That's wrong. Now you are claiming it's "not enough". That's a separate discussion on how to allocate priorities within a finite budget.

 

Would you say that 'euthanasia is used in place of an emotional word?

 

I'm saying it is the correct term. It is the word that corresponds to what is being done.

 

'Animal testing' is wrong because it doesn't give a sense of the wrongness of it. The animals don't and can't volunteer. It is as wrong as testing on humans against their will.

 

There is the non-sequitor again. You are trying to extrapolate morals that apply within our species to between species. You can't do that.

 

I don't know what you are trying to say here. As I said, in the clinical trials many or most of the people will hope or think they are on the drug. That will give whatever it is a boost.

 

No. What it will do is take away any "boost" and make the drug look less effective. Look, the placebo is an effect x. The drug has an effect y. Because of double blind and everyone thinking they have the drug, what we measure is y in the experimental group and x in the controls. The overall effect we see is y - x. So if x diminishes the apparent effect y.

 

After a drug has been approved, it is invested with a certain power. The more it is hyped, the more powerful it becomes.

 

Doesn't matter. The randomized double blind studies have already given us the real effect. The effect you are talking about only matters in those cases where randomized double blind studies have not been done, such as "herbal" medicines and nutritional supplements. There the entire effect could be due to what you describe.

 

A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect

 

Again, doesn't matter: because we already know the real effect from the clinical trials!

 

I replied by saying: 'Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans.'

 

To which you posted: '1. Because of evolution, knowing about other animals does help us know about humans. We are related to other mammals by descent with modification.

2. And that part of research "not applicable to humans" is part of the falsification I talked about above. That is the part we are certain about. However, we wouldn't know it was not applicable to humans unless we had done it first.'

 

I said: 'The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes.'

 

Your last statement has some assumptions:

1. It presumes that drugs that fail animal testing will pass clinical trials. Why would you think that?

2. You are assuming that all the failures in clinical trials are due to failures in animal testing. But as you noted, "I know that drugs can fail for commercial reasons." This destroys your assumption.

 

When the assumptions are wrong, the conclusions are going to be wrong.

 

 

I said that I have no evidence for IACUC conflicts of interest. But, as other regulatory bodies have been proven to have such conflicts, it's not unlikely that they can be found in IACUCs.

 

You are trying guilt by association. You know that is an invalid argument.

 

IACUCs have shown negligence and incompetence.

 

You never demonstrated that. Please do so. Were they really incompetent or were they nobbled? If they can be so incompetent, it doesn't say much for their ability to do the job they are supposed to do.

 

Not all data are published. ... If there wasn't a paucity more drugs would succeed.

 

That does not follow. Since most time studies are not published because the data is negative -- no efficacy -- it means that publishing data that the drug was ineffective is not going to make the drug "succeed".

 

It can't be known if those that never reached human testing would have been successful or unsuccessful in humans.

 

Again, why the double standard? You care a lot about the safety of animals and not to try drugs on them. But you have no similar care about the safety of your fellow human beings. Is it because you, by your own admission, take no drugs and therefore will not be one of those to test an unknown drug for safety? That seems very selfish on your part. You want drugs for human treatment -- even ones to treat you someday -- but you won't volunteer for safety testing.

 

Most drugs that go through cruel testing don't manage to wangle their way through human testing. They are found wanting. And what they are wanting is proper medical research.[/quote

 

They have "proper medical research". What they lack is

1. Adequate safety (which means VERY, VERY safe).

2. Commercial prospects.

 

It was known decades earlier that substances could cross the placenta. Which species could they have used to check for teratogenicity? Which species would they have believed? If they'd never tested for it before, how would they have known which species was supposed to be a model?

 

They had tested rodents as models for toxicity and they were very good models. Chemicals that were known to be teratogenic on humans were also teratogenic on rodents. It turned out that thalidomide was a tragic exception: it was not teratogenic in rodents but was in humans. However, thalidomide was teratogenic in primates (monkeys). But, in deference to animal rights people like you, testing in primates in Britain at the time was not done.

 

Thalidomide actually points to the danger of your position: animal models were skipped and look what happened. Now you want to skip ALL animal models and go directly to humans. If thalidomide was teratogenic at 1/100th the usual does, even pregnant women getting the microdose would have had deformed children. But you don't care about that, do you? As long as the animals are safe.

[xnebulalordx676]

Wrong for the most part...basing this on scientific basis not morals per say.

 

I am not going to argue. I am politely going to state my scientific basis sought defined opines for the record.

 

I am against this one if anything involving acids harsh. Also punching pigs in the stomach like GM motors does for auto tests. I am against testing on animals when the results will be obviously torturous with obvious signs of howling pain. I find pointless the more shallow testing such as solutions being dropped into their eye. I say Humans simply don't need tests for dumb extras like shampoo.

 

 

As for medicines I trust herbs cure most. But I am pro medicine experiments especially sedatives (instructing to someone). Since sedatives are most useful and accidentally end up being most humane.

 

Animal testers are more frequently looking more for results of pain more than the pleasure of animal so that I find to be the disturbing factor.

 

 

I am against dissecting on an animal while still alive. I am against this since life forms that are eaten are killed for a different purpose of immediate self preservation only. I do not see basis for the dissecting while alive or experimenting acts.

 

They can always get dead animal pulled from a field somewhere to do gun shot blasting.

SO I guess for the most part I don't get the need for whole experimenting thing.

 

 

The majority of problems have been solved for man. SO I don't get the whole experimenting thing.

 

I am fond of eating flesh. I am also fond of being as humane as possible.

[PeacheyCarnehan]

jdurg (Resident Expert) 09-17-2008, 06:06 PM #433

PC, I really don't appreciate you calling me a "minion". Your statement that "Drug companies and their minions" when do whatever they can to sell their drug is insulting, and rude. Again, show me that you have worked in the pharma industry and you know everything about the industry.

 

If you so strongly feel that animal testing is wrong then don't EVER take a medication, don't EVER go to an ER when you are severely ill, and don't EVER take any drug to ease a life threatening condition.

 

Better yet, make it your life's goal to shut down every pharmaceutical company on earth and then you can take the responsibility for the death and loss of well being for the millions of people that these "Evil Corporations" provide life and happiness for.

 

Yes, the corporations do have profit in their mind with what they do. This "profit", however, is what pays for every single worker in that company from the custodians, to the security guards, to the people like me who work our asses off on these trials. I am NOT going to work for free which is what many people, yourself included, seem to want.

 

When I mentioned 'minions' I had in mind the people who work for drug companies and those who make decisions about drugs after taking drug company money. And also lobbyists. About taking medications: anyone who needs a pharmaceutical drug has no option but to use one that has been tested on non-humans. I would say avoid them if you can but don't be a martyr if you do need them. And hope they do work and won't poison you. As I said in my first post, if one is opposed to the oppression of humans one shouldn't use anything that has been made by humans. At one time, human oppression will likely have been part of it. I also said that all non-Indians should leave the American continent because the first white people who invaded the continent slaughtered and oppressed the indigenous peoples. And then later brought in black slaves. Those slaves had an important part in making much of North America prosperous. But I don't expect people to leave America. To live in this world we need to make compromises.

 

I'm not against profit. I merely point out that where there is big money there will be big corruption. It's human nature.

 

 

Originally Posted by PeacheyCarnehan

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

The statements below are from FDA documents or communications written in 2006 that are talking about improving the drug development process:

 

'Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.'

http://www.fda.gov/bbs/topics/news/2006/NEW01296.html

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

 

You need to read the whole page. This isn't saying that animal testing is faulty, but rather that human testing is faulty. Basically, what they are saying is that researchers don't have to adhere to the rules of manufacture needed for distribution to the public:

" “The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution," said Janet Woodcock, MD, FDA Deputy Commissioner for Operations. "These requirements are so burdensome for early phase 1 studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories. Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies." "

 

So, the article doesn't support your claim.

 

The article does support what I said. Both Leavitt and von Eschenbach said that 90% of new drugs fail in clinical testing, largely because the preclinical lab animal and lab studies couldn't accurately predict how the drugs would behave in humans.

 

They say that modern methods must be used to decide what goes into clinical trials, because the current methods - including the use of non-humans - are not good enough and get it wrong very often. They want the use of new technology to better decide which drugs have a chance of succeeding in clinical trials. They think the new guidance on exploratory studies will help in this area. Janet Woodcock was saying that the burden of abiding by rules for manufacturing drugs for phase 1 studies can prevent research institutions from even putting them into clinical trials. Those drugs, that didn't go into clinical trials because the researchers couldn't provide proper manufacturing procedures, aren't counted amongst the 9 out of 10 that fail in clinical trials.

 

Yes, it does. Remember, the prime criteria for a drug is safety. Not efficacy. The rules are skewed toward safety. I, personally, don't like the new rule because they are now being skewed toward the profits of the drug companies. Under the new rules, we are likely to get more situations like Vioxx where there are low level safety threats that are not caught.

 

David Graham, of the FDA Office of Drug Safety, doesn't think the rules are skewed towards safety.

 

You're logic here is illogical. You seem to be saying that we would have greater success in humans if we ignored the animal data that says a drug is unsafe in humans. That's silly. If we just take the in silico data and go directly to humans, it means that, instead of 1 in 10 that pass clinical trials, it would be 1 in 100 or 1 in 1,000.

 

I said they place great reliance on lab animal data. I wasn't talking about drugs that fail in the preclinical stages. I was talking about drugs that go to clinical trials. I said the reliance on that lab animal data is misplaced. It leads to very few drugs getting through the clinical trials.

 

This has nothing to do with the value of animal testing. If you skip animal testing it means that the drug companies would have 10 times the number of drugs to try to promote by means that you say are immoral.

 

I was replying to a statement that said the drug companies don't need to find a reason. My reply showed why they do need to find reasons.

 

Why? Is it wrong for a lion to deprive a zebra of health and life? Is it wrong for us to deprive a corn plant of health and life? PC, you keep ignoring that EVERY animal species must deprive another living organism of "health and life". If it is absolutely wrong to do so, then humans must starve themselves to death. You must forgo all future meals because each of them is going to involve depriving some organism of "health and life". Even if you confine yourself to dairy and eggs, how dare you cage animals so you can milk them or gather their eggs?

 

I thought you were joking when you earlier said something similar. Lions can't do things differently. They evolved to kill zebras and other animals. We didn't evolve to torture other species. We choose to do it. For our own ends. We can decide not to do it. I don't eat eggs or dairy products.

 

Really? NO way at all to determine whether something is right or wrong? You've never taken an ethics course, have you? Let's go to murder. Is murder ever "right"? I don't mean killing, I mean murder: killing for one's personal gain.

 

It is merely opinion that murder is wrong. Lions kill for their personal gain. They don't think it's wrong. We do think it's wrong because we can think it's wrong. The ancient Romans didn't always think it was wrong. It was sometimes entertainment for them.

 

Then why do you still go on eating? You don't give the benefit to those who suffered and died to provide that food, do you?

 

Eh? Are you a wind-up merchant? I am a vegan. Plants don't suffer. There are people here who don't think rats suffer by losing their lives or being imprisoned and experimented upon.

 

How do you know? Have you tried?

 

No, I haven't tried. I don't need to. I wouldn't take up an offer by the Mafia to see how law abiding their daily lives are and what nice people they are, either. No sensible person would believe anything they showed to prove those things.

 

First, what you have pointed to are isolated incidents of corruption. How many drugs are on the market? How many have had to be pulled like Vioxx? Do the math. You need over 50% before you can say "widespread".

 

Second, you contradict yourself with this statement: "I said that I have no evidence for IACUC conflicts of interest." So no evidence for corruption one the point that we are discussing here, namely, whether animal studies are conducted according to the regulations to minimize pain and suffering to the animals.

 

The pulling of drugs is not a true indication of corruption. It is sometimes corruption that helps them to be approved and to stay on the market. If there was no corruption, more would fail to be approved and more would be recalled or relabelled.

 

I have no evidence of IACUC corruption but I have shown evidence of negligence and incompetence. There is lots of evidence for the corruption and conflicts of interest in other parts of the drug/medical research world.

 

From the United States Department of Agriculture's 2005 Audit Report on Animal Care Programme Inspection and Enforcement Activities:

 

======

OIG’s (Office of the Inspector General) previous audit28 of APHIS’(Animal and Plant Health Inspection Service) enforcement of the AWA (Animal Welfare Act) found that the activities of the IACUCs did not always meet the standards of the AWA. Some IACUCs did not ensure that unnecessary or repetitive experiments would not be performed on laboratory animals. In addition, the audit found numerous problems with protocols and reporting.

 

To assist the IACUCs in accomplishing their responsibilities, APHIS and the National Institutes of Health issued detailed laboratory guidelines on animal care. Nonetheless, we noted some IACUCs are still having problems in such areas as adequately monitoring researchers for compliance with their protocols (e.g., the search for alternatives, review of painful procedures, and unnecessary duplication of research) and following up on the correction of deficiencies. During FYs (Financial Years) 2002 through 2004, the number of research facilities cited for violations of the AWA has steadily increased. In FY 2002, 463 of the 1,030 facilities were in violation. In FY 2004, that number increased to 600 of 1,176 facilities.

 

IACUC Monitoring of Research Facilities

 

In FY 2000, APHIS conducted a survey of 40 VMOs (Veterinary Medical Officers) and their 9 supervisors to assess their opinions on the effectiveness of the IACUCs. In general, VMOs concurred that IACUCs need to improve the search for alternatives, the review of painful procedures, and monitoring the researchers’ use of animals to ensure compliance with approved protocols and standard operating procedures. The survey concluded that “IACUCs seem to be doing well at functions related to setting up the administrative structure and developing the process but not as well at monitoring and follow through.”

 

In FY 2004, we re-surveyed 30 VMOs and their supervisors to determine if the IACUCs improved their performance. Although most VMOs believed that the IACUCs improved in certain areas, VMOs still found a total of 6,801 violations at these facilities from FYs 2002-2004. The VMOs believe there are still problems with the search for alternatives, veterinary care, review of painful procedures, and the researchers’ use of animals. Using AC’s (Animal Care unit) database, we compiled and analyzed the data for all inspections conducted at research facilities from FYs 2002-2004. Table 2 shows the most frequent violations cited by the VMOs.

 

IN THEIR TABLE FOR THE MOST FREQUENT VIOLATIONS AT RESEARCH FACILITIES FOR FINANCIAL YEARS 2002-2004, THEY SHOW THE FOLLOWING INFORMATION:

29% of facilities were in violation of a Search for Alternatives to painful procedures.

26% were in violation for not reporting by IACUCs of evaluations of animal facilities to the institutional official.

18% were in violation for not maintaining adequate veterinary care that includes appropriate methods and availability.

17% were in violation for not having protocols containing a complete description of the proposed use of animals.

9% were in violation for not meeting standards of care regarding housekeeping for rabbits.

 

 

We reviewed AC files for 58 research facilities; some of the violations we noted were:

 

• An IACUC in California approved a protocol for the production of antibodies using approximately 80 rabbits. Instead, 1,024 rabbits were used under this protocol. IES (Investigative and Enforcement Services) is currently investigating this case.

 

• Another research facility in California failed to give a post-surgical nonhuman primate analgesic to relieve unnecessary discomfort and pain after a craniotomy in which four burr holes were made into the cranium. It also failed to provide post-surgery veterinary care.

At the same facility, a post-surgical lamb was observed to have difficulty breathing and was frothing from the mouth. The lamb was not monitored until an AC inspection identified it to be in distress. A second post-surgical lamb was found dead. This facility was referred to OGC (Office of the General Counsel) for legal action.

 

• A research facility in Illinois failed to provide adequate veterinary care, which resulted in the death of a primate and a pig. The IACUC also failed to approve protocols or to review significant changes to protocols. The fine was $9,400.

 

• At a research facility in Indiana, AC inspectors found proof that a summer intern was improperly trained to perform operations on animals. Evidence indicated that the trainer left the area during another intern’s first surgery. The fine was $4,000.

 

According to our analysis, 33 of the top 50 (66 percent) research facility violators in the nation were educational institutions suggesting that IACUCs at universities are less effective (see exhibit C). The VMOs explained that universities usually have more protocols, the protocols are more varied, and students are less experienced in good laboratory practices. Even though the top 50 facilities were cited for numerous violations over a 3-year period, records indicate that only nine were referred to IES for investigation.

 

In FY 2003, AC received a petition from the Association of Veterinarians for Animal Rights, which cited frequent violations concerning the search for alternatives. AC responded to the petition by conducting inspections at all veterinary schools in the nation. The inspections focused on teaching protocols and cited numerous violations in the search for alternatives, unnecessary duplication of research, and justification for the number of animals used.

We also learned that in a very few cases, the facilities were resistant to change, showing a general disregard for APHIS regulations. VMOs informed us that some institutional officials were not supportive of IACUC activities and APHIS regulations, resulting in significant issues with animal care at the facilities. In one example, the research facility ignored the VMO’s reports of violations and did not take corrective action for several years. In cases of negligence of fiduciary duty, APHIS should seek an OGC opinion to determine if institutional officials can be held personally liable.

 

Inaccuracies in Annual Reports

 

We also found that the majority of research facilities we reviewed misreported the numbers of animals used in research. Some facilities did not follow APHIS guidelines for completing their annual reports, while other facilities are not using the numbers of animals supported by their records. As a result, APHIS is misinformed about the true number of animals used annually in research facilities throughout the nation (as noted in finding 3).

 

Regulations state, “The annual report shall state the common names and the numbers of animals upon which teaching, research, experiments or tests were conducted…” AC Policy as well as the instructions attached to the template annual report state that animals used in multi-year studies will be counted once each year.

 

We visited 16 registered research facilities that were cited for violations in the past 3 years. After comparing the most current annual report submitted by each facility to the supporting documents on hand, we found that 13 of the 16 research facilities misreported the numbers of animals used in their research. Of these facilities, nine had underreported, three had overreported, and we could not determine the actual number of animals used in the remaining facility. Some facilities agreed to resubmit an amended annual report.

 

Although research facilities must be registered, APHIS has no authority to revoke the registration of a noncompliant research facility. Even administrative law judges may find it difficult to terminate or refuse to renew registrations in cases where serious or repeat violations occur because USDA does not have the authority to interrupt the conduct of research.

 

We concluded that IACUCs need to improve their monitoring of researchers for compliance with the protocols (e.g., the search for alternatives, review of painful procedures, unnecessary duplication of research), in following up on the correction of deficiencies, veterinary care, and in reporting accurate annual reports to APHIS. This is imperative because although AC can temporarily revoke licenses for breeders and exhibitors, this is not the case with research facilities. The AWA does not authorize “the Secretary, during inspection, to interrupt the conduct of actual research or experimentation…” Therefore, it is more critical for AC to take enforcement actions against research facilities that violate the AWA (refer to finding 1).

 

=======

 

So much for IACUCs. APHIS and the NIH had to issue IACUCs with guidelines. This means that some of them didn't know how to do the job they were supposed to do. They had to be held by the hand and shown what to do - after they hadn't been doing what they were supposed to do. And even after that some were still not doing their job. How many times do they need to be told or shown what to do and how to do it?

 

In 2002, 40% of research facilites were in violation of AWA rules. That increased to 50% in 2004.

 

Of the worst 50 violators amongst research facilities only 9 were referred to the IES. Not an indication that much is done to bring perpetrators to book. And then they only get fined a few thousand dollars. That's only an 18% chance of being punished. Bank robbers would jump at that chance - especially if the punishment was a slap on the wrist. There seems to be even little chance of a research facility, guilty of serious and repeat violations, losing its registered status or of being refused renewal of registered status.

 

This is science. We can independently check it.

 

Your reply is to something different. Originally, there was a comment somewhere that said: 'In my mind, cruelty is putting a cat into a microwave. Cruelty comes in many forms, but the responsible tests done in the name of science does not fit those criteria.'

 

I replied to that on page 20, post 393 with: 'In my mind, using any animal that can feel pain or fear in ways that will cause it pain or fear or that will cut short its life, is cruel. As has been said before, at one time it was not thought cruel to kidnap humans, take them across the sea, and make them work as slaves.'

 

There was a reply to the part about slaves: 'Yes, however this was due to the appalling conditions (of both transport and treatment after sale), and the use of sentient, self-aware, and self-determining beings as unpaid, "owned" labourers.'

AND:

'The second objection is not applicable to animals. The first is not manifest in the vast majority of animal test organisations, due to the incredibly strict regulatory practices which have already been described at length in this thread.'

 

I wanted to reply to the bit about 'strict regulatory practices' so I quoted part of it: '...due to the incredibly strict regulatory practices which have already been described at length in this thread.' And replied to that quote with: 'I have already shown that these regulatory practices are open to abuse. Well, I haven't shown evidence for that yet but I can. I was waiting until someone challenged me. I have all the evidence just waiting. If some system can be abused and there is money to be made by doing so, it will be abused. Drug companies and some medical researchers have already shown their disregard for human life. The welfare of rats and monkeys will be of even less concern to them, especially when measured againt profits or the thoughts of prestige for making some discovery or authoring some highly-praised study.'

 

Sayonara quoted part of my reply, the bit beginning with: 'If some system can be abused and there is money to be made by doing so....' And said: 'I don't particularly disagree that any of this can or does happen, but unfortunately for you it is not an argument against the conventionally regulated system of animal testing which is in place.'

 

I replied to that with: 'We can't have any faith in the system. When someone involved says that something is necessary we can't know if they believe that, mean that, or just want to protect their interests.'

 

Your reply of 'This is science. We can independently check it.' is not relevant. I was talking about the lack of trust that can be placed in anyone involved in this business who says that there are safeguards and that the lab animals don't suffer. I said that they might or might not even believe what they say. They could say it because it protects their interests. Or because it will trick a gullible public into believing that the cruel experiments they perform aren't cruel. But there is lots of evidence that the strict regulatory practices are not being strictly practised.

 

Moral standard apply within a species. It is how we treat other members of our own species. I've already demonstrated why we cannot export absolute morals to our relationship with other species.

 

As it happens, I agree with you that "torture" of animals is wrong. By "torture" I mean here giving pain for personal pleasure. As you noted, we as a society have decided that we can lock people up or subject them to stress or pain if it is for the good of others. Are you advocating that we let all people in prison go? Why not? Aren't they locked up as you say animals in animal testing are? Do you want the child molesters and rapist back out on the street? Why not?

 

I submit that it is moral to involuntarily lock up human beings for the good of others. If so, then we can "lock up" animals for the good of human beings.

 

It is cruel to subject anyone to torture. Whether it is expedient is beside the point. Moral standards concerning pain and suffering apply to all those who can suffer or feel pain. By 'torture' I mean here causing pain or fear for any purpose that doesn't benefit the one on the receiving end. I don't believe it is right to subject anyone to pain for the good of others. And I have not suggested we let prisoners out of prison. They are locked up because they are a danger. The animals in labs are locked up for purposes that don't benefit them, not because they are a danger. The two cases are completely different.

 

But was Merck required to provide the data? YES! What you have is criminal wrongdoing by people within a drug company. As I asked, do we shut down all nursing homes or orphanages because of criminal wrongdoing by a few? You never answered that.

 

I have not proposed that drug companies should go out of business or regulators be abolished. I am calling for proper policing of those areas. I pointed to wrongdoing to show that there is the real possibility that any of them could be corrupt. No, we don't shut down all nursing homes because of the wrongdoings of some people. We put in place better methods of catching them early. Merck's wrongdoing is just one small part of the corruption and conflicts of interest that are widespread in the drug and research world.

 

Another recent case of withheld data was that of Bayer's drug trasylol.

 

Here's part of an article about Bayer's withholding of information about the drug during an FDA committee meeting. They later admitted that they had extra data but only when a whistleblower threatened to expose them. There will be other cases that haven't come to light where drug companies have withheld data from regulatory bodies.

 

============

On September 21, the FDA held a meeting of their Cardiovascular and Renal Drugs Advisory Committee specifically to discuss the safety of aprotinin injection, which is sold by Bayer under the trade name Trasylol. (Trasylol is used to reduce blood loss, prevent low blood pressure, and limit the need for transfusions in patients undergoing major heart surgery.) The main question at hand at the meeting: Is Trasylol usage associated with elevated risk of renal failure, myocardial infarction, heart failure, or stroke?

 

Present at that meeting were two Bayer executives: Michael Rozycki, Ph.D., director of U.S. regulatory affairs, and Pamela Cyrus, M.D., vice president of U.S. medical affairs. Joined by two outside professors, the Bayer group made a presentation to the committee that included an overview of the subject, a risk-benefit assessment, a review of clinical data, and a discussion of the methodology of two independent studies published in 2006–one in Transfusion and one in the New England Journal of Medicine–that called into question the safety of Trasylol. They were also asked to provide their own “recent safety and efficacy data” to the committee.

 

According to the FDA's official minutes of the meeting, committee members were then asked to vote on the following: “Based upon the presentations today, do you regard the totality of clinical data as supporting acceptable safety and efficacy for Trasylol usage among certain patients?” Eighteen members voted yes, one abstained. There was some talk of changing the label warning language–from “increased risk” to “high risk”–but no changes were approved.

 

All things considered, there was nothing out of the ordinary to be found here. But on September 29, about a week after that meeting took place, the FDA made a rather unusual statement regarding Trasylol and its safety:

 

“Since January, 2006, the Food and Drug Administration (FDA) has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack, and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

 

“On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.”

 

While the FDA was “not aware of these new data” at the time of its meeting, Bayer's Global Drug Safety Group certainly was–and yet the company failed to share these new findings with committee members at the September 21 meeting. So far, Bayer has not been punished in any way for what they officially called an “error.” Yet, the question remains: Was Bayer engaged in any criminal wrongdoing and should they be subject to criminal charges?

 

“The FDA ought to be investigating whether there was a willful attempt to withhold relevant information at this hearing,” says Steven Findlay, a health care analyst at Consumers Union and managing editor of Consumer Reports Best Buy Drugs. Findlay is the “consumer representative” of the Cardiovascular and Renal Drugs Advisory Committee and a voting member who was present at the meeting. If Bayer representatives at the meeting “knew of the existence of the study and consciously, with conspiracy, withheld the results,” Findlay says, they may be vulnerable to criminal proceedings by the Justice Department.

 

Another voting committee member present at the meeting, John R. Teerlink, M.D., associate professor of medicine at the University of California, San Francisco, claims that Bayer did not provide sufficient and accurate data on which to base his decisions. “I believe that there should be consequences for Bayer in withholding this information,” Teerlink says. “If possible, the punishment should be severe enough to provide a deterrent for future such actions.”

 

It is quite possible that the FDA would not have known of the existence of Bayer's most recent data had it not been for a whistleblower who forced Bayer to disclose the information following the September 21 meeting. Apparently, that whistleblower was Alexander Walker, a professor at Harvard and a researcher at Ingenix, the research group that was contracted to do the study and analyze the data. Bayer subsequently notified the FDA of its internal study on September 27.

 

In that internal study, the contractor examined 67,000 hospital patient records and found an elevated risk of death, serious kidney damage, congestive heart failure, and stroke in Trasylol patients. According to the company, the results were originally withheld because they considered the data preliminary and questioned the validity of the methodology. But at the September 21 meeting, they failed to even acknowledge the study's existence.

http://www.newsinferno.com/archives/1284

 

=====================

 

Of course we can't go back retrospectively. Again, what you are talking about is closing the loopholes in a system. That is not an argument that animal testing should not be done. It's only a comment that we weren't policing the industry better.

 

And notice, this problem is only going to increase if you allow drug companies to skip animal testing.

 

I don't recall what my original full statement was about nor what it was in reply to, and I'm not going to look back to see what it was. I will reply to your above post.

 

Loopholes can usually be found. And if they can't be found, the rules can be ignored, especially when many millions are involved. Very often it is only whistleblowers who alert us to the rule breaking.

 

The FDA wanted to (and perhaps still does want to) allow drug companies to use journals for promoting drugs for unapproved uses, as shown in the letter below.

 

Letter to Andrew von Eschenbach, Commissioner of the FDA From Henry Waxman, Chairman of the US Committee on Oversight and Government Reform

November 30, 2007

 

========

Dear Dr. von Eschenbach:

 

I have obtained a copy of an October 2007 internal draft of new FDA guidance that

would allow drug companies to use journal articles to promote potentially dangerous uses of

drugs and medical devices without prior FDA review and approval. It is my understanding that

the FDA intends to issue this guidance without significant changes in the very near future. I urge

you to refrain from going forward with this ill-advised guidance.

 

A fundamental tenet of our drug and device laws is that a manufacturer cannot market a

drug or device for a therapeutic use without FDA approval. The draft guidance would carve a

large loophole in the law and create a pathway by which drug and device manufacturers can

promote unapproved (off-label) uses of their products without first obtaining FDA approval by

passing out journal articles about the off-label use to physicians. Published reports of company funded studies can be biased in favor of the company’s product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products.

 

The draft guidance that I have obtained would, in effect, allow drug and device

companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully

constructed to deliver positive results and then using the results to influence prescribing patterns. This undercuts the prohibition on marketing of unapproved uses of drugs and devices and puts the public at risk for ineffective and dangerous uses of drugs.

 

The draft guidance poses multiple risks. First, it appears to be based on the premise that

peer-reviewed reports provide accurate, validated information and that even if individual articles are biased, the published literature as a whole can provide balance. Regrettably, recent

experience shows that this is not always the case. There have been a number of high-profile

instances in recent years where journal articles provided a distorted picture of a drug’s safety or

effectiveness. This has been in particular a problem in the case of journal articles based on

studies funded by drug companies.4

 

The danger to patient health should be readily apparent from the examples of journal

article abuses described in the addendum, including anti-depressants, Vioxx, Celebrex, antiarrhythmics, Neurontin, and other False Claims Act settlements. Drug and device companies can manipulate and selectively distribute studies in order to make their products appear safer and more effective than they truly are. Where the unapproved uses are actually ineffective, patients have been denied other, more effective treatments and have been unnecessarily exposed to the ineffective products’ known side effects. Even worse, patients have suffered serious harm due to unanticipated and serious side effects of unapproved uses.

 

online.wsj.com/public/resources/documents/waxmanletter_113007.pdf

 

Read the whole letter. Very interesting.

======================

 

I was saying that the data could not be hidden, not that it wasn't published. In science, most studies with negative data are never published. The FDA had ALL the data when they approved the drug. This isn't about data being hidden, it is a complaint that doctors should have all the data at their fingertips " By altering the apparent risk–benefit ratio of drugs, selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health.' "

 

Now that all the FDA data is on the web and can be accessed by physicians, this problem disappears.

 

Can we really be sure that no data is ever withheld from regulatory bodies? Can we be sure that regulatory bodies always have the best interests of the public in mind?

 

David Graham of the FDA said that drug firms try to get their drugs approved for anything if they can't get it approved for the condition they really want it to be used for. Once it's approved, their salesforces can then whisper into the ears of physicians about how it can be used for other things. There have been cases where physicians prescribed some drug for some patients with some ailments for which the drug was not proven safe or where there was a definite possibility of danger - despite the label mentioning these concerns. A database of clinical trials is no more likely to influence prescribing patterns than are those drug labels if journal articles and drug company representatives can put ideas into physicians' heads. If elements in the FDA had their way, the drug companies could make all sorts of claims in medical journals about the efficacy of their drugs without having to go through the usual approval process. David Graham, of the Office of Drug Safety, says that the FDA's Office of New Drugs likes to accomodate the drug companies in getting drugs approved for some condition or other if at all possible, perhaps for some condition that only affects a small number of people.

 

The drug companies can then persuade physicians to use it for other things. And I would add: as long as they are not definitely obvious killers.

 

Various members of the US Congress have repeatedly written to the FDA with concerns about their attitude to drug safety. Anyone who makes a study of the drug world will come to the realisation that the FDA has influential members who are more interested in pleasing the drug companies than in ensuring drug safety. There are many people in the FDA who try to do a good job but they are not powerful enough to change the organisation from within.

 

Congress recently subpoenaed documents from the FDA. The Health and Human Services Secretary refused to hand them over, saying that the FDA was conducting an internal investigation and they didn't want to jeopardise that by handing over documents! They refused to comply with a subpoena. If some workers in an iron foundary were killed in an accident and the police went in to investigate if there had been a case of criminal negligence, the company wouldn't be able to tell them to go away. I can imagine what the chairman would say to the police: 'No, no, we won't co-operate with you. Our security staff are carrying out an investigation. They are all good people, all ex-coppers. The head is actually your esteemed ex-colleague, Bazza Blenkinsop of the Yard. So go away and let us get on with our investigation.'

 

I believe that some access to the documents has more recently been granted after the HHS Secretary, Leavitt, was threatened with contempt of Congress.

 

Many times, the FDA has been advised by its own scientists to put certain warnings on drug labels but the FDA has not done so. Some of these scientists are then demoted or moved to another job. One such case was that of Rosemary Johann-Liang, the Deputy Director of the FDA's Division of Drug Risk Evaluation. According to insiders, she was demoted after she approved recommendations for black box warnings for the drug avandia.

 

And another of their scientists, Andrew Mosholder, was muzzled when he found the possibility of antidepressant danger in children and wanted to make his findings public.

 

This may happen in Britain, but I know from personal experience that US medical schools and universities put in clauses in the contracts that specify 1) access to all data and 2) the right to publish.

 

It was mentioned in US journals. And, rules have been ignored before. The rules in universties could be ignored. For example, a certain university person has exceeded the $10,000 a year amount for income from drug companies. On two or three occasions when the university reminded him that he was receiving more than he should he told them that he would keep to the agreed maximum amounts. Then proceeded to take more money.

SenateLetter081003.pdf

.

All journals now require a statement that all authors take complete ownership of all the data in the paper.

 

This will only apply to the member journals of the ICMJE. There are about 11 or 12 members. And even then, there have been cases throughout history where people have signed documents without any intention of honouring the spirit of the document. But, on the whole, this is a good move - to require the authors to confirm they have had full access to the data.

 

That is a separate issue from whether animal testing is right or wrong, isn't it?

 

I was asked for evidence for what I said. And it is partly in support of my argument that the evidence for the rightness or wrongness of cruel experiments is filtered through the potential for corruption.

 

You haven't demonstrated that for animal studies. In fact, you haven't even demonstrated that safeguards for human studies are ineffective or are ignored. What you have demonstrated, at most, is that false report ing has happened. NONE of your sources ever said that the safeguards for the human subjects were not effective or were ignored.

 

You said above that something is a separate issue from whether or not cruel experiments on lab animals are right or wrong. So is the question of human safeguards. I have shown that IACUCs can be and have been negligent and incompetent. And that those that deal with commercial research can be even worse. I said, and demonstrated, that the safeguards for the lab animals are inadequate and often ignored.

 

You had said:

PC, you are slipping between 3 different claims:

1. Animal studies themselves are immmoral

2. There are NO safeguards for animals.

3. There are abused of the existing safeguards on animals.

 

AND: You are trying to use examples of #3 to argue for #1. But that doesn't work. Let's take this out of animal testing. As you noted, there are occasional abuses of children in orphanages and the elderly in nursing homes. In both cases there are safeguards in place. However, even tho there is the occasional abuse it does not follow that it is immoral to have children in orphanages or the elderly in nursing homes!

 

So I replied:

1. I do say that cruel experiments are immoral.

2. There are no effective safeguards. The safeguards in place can be and have been ignored.

3. There are abuses of the rules.

 

AND: It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims.

 

You haven't demonstrated that for animal studies. Again, you haven't demonstrated that the rules for safeguarding human subjects were abused. All your examples are about abuses of the rules for reporting data.

 

See above.

 

You logic is a bit hard to follow here. You are arguing simultaneously that animal testing failed to pick up drugs that were harmful to humans. Therefore, you logic goes, all the drugs that were harmful in animals should be OK in humans and therefore we should go to clinical trials.

 

If 9 in 10 drugs that were not harmful in animals turned out to have insufficient safety for humans, why would you think that the drugs that were not harmful in animals would not have at least the same ratio?

 

You quoted my reply to your statement: 'But animal models do simulate reliably. All the drugs and treatments on the market, and all the drugs and treatements witheld from clinical trials attest to that. Clinical trials are done because we insist on double-checking the results from animals.'

 

My full reply to that was: 'But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans.'

 

I have not said, nor do I believe, that all the drugs that were harmful in other species would be safe in humans. I have said that we can't know what they would do in humans. I am saying that by using other species you can't know beforehand what a new drug will do in humans. And I have not said that all of the 9 in 10 new drugs that fail in clinical trials fail for reasons of safety. It can't be known what the drugs that haven't been tested in humans will do to humans.

 

Similar is not the same as "identical". You don't place much morality on causing harm to your fellow humans, do you? If you think it immoral to cause pain and suffering on animals, why are you so eager to put humans at risk for pain and suffering? We check to avoid any possibility of pain and suffering to humans.

 

You are referring to something that wasn't said. I have never said that drugs should be tested on humans without previous testing on other things. You believe that other species should be these other things. I don't. I think you believe that when I said: 'If it is similar to other existing drugs, why does it need testing?' I was advocating that similar drugs don't need testing and can be given to humans. That is not what I meant. I said that it is not known what a new drug will do. If it is a new drug - even a drug very similar to an existing one - it will need testing. It is not an identical drug. It would only be identical if it was the same drug. I went on to say that it needs testing - no matter how similar - because it is a new drug and it is not known what it will do.

 

Yes, you did. I quoted you.

 

 

And what good does that do? That could give you very misleading results because you haven't reached the toxic threshold. Remember that therapeutic index I talked about? If the index is 1:100 you won't detect anything at the microdose, but you will kill the person at a full dose.

 

Your above statement was in reply to my statement that I hadn't said a new drug should be first tested in humans. You even quote me as saying the first trial in humans should be a mini-micro dose. That is after extensive in silico, in vitro and other testing. When everything else has been done, the drug can then be given to patients or volunteers at a dose that is all but non-existent. And gradually increased. Even if it takes a year or more to get to a pharmacological dose or a therapeutic dose. At present, humans test a drug that has had its starting dose devised by previous investigations. Mainly in other species. It is not known how a new drug will affect those first humans. That is why many drugs are pulled at that stage for safety reasons. Those first humans could be putting their lives or health in danger until it is known for sure what the new drug will do. It can only be known for sure what it will do in humans after it has been used in humans.

 

Ah, so another reason for you not to volunteer! But rememmber, you are using humans for the "exhaustive safety testing"! It's animals that are the first line of exhaustive safety testing and you want to eliminate that.

 

I didn't advocate exhaustive safety testing in humans.

 

That's a different argument. Your innitial claim was that NO money or effort was being devoted. That's wrong. Now you are claiming it's "not enough". That's a separate discussion on how to allocate priorities within a finite budget.

 

I'm not going to check if I first said 'no money' or 'not enough money'. I think I said that not enough is used. It doesn't matter, though. I have been aware for many years of the search for other methods. And I have known for years that that search needs money and that money is being spent. Not enough money is being spent. I know there is a finite budget because that's what priorities have dictated. I have been saying for years that more needs to be spent. It all depends on what is considered most important. I don't want to get into a discussion on economics and politics. I say that not enough money is being spent.

 

I'm saying it is the correct term. It is the word that corresponds to what is being done.

 

And I am saying that killing is killing.

 

There is the non-sequitor again. You are trying to extrapolate morals that apply within our species to between species. You can't do that.

 

I can do that. But I was saying why the term 'animal testing' is not the correct term. It should be 'vivisection' because that gives a better sense of what is going on. 'Testing', as I said, could be something pleasant and desirable. 'Vivisection' cannot be seen as pleasant or desirable. It conveys a better idea of the abuse that occurs. By 'abuse' I mean here using anyone in ways that can damage them or deprive them of their natural lives for purposes that don't benefit them (quite apart from any pain or terror that might be caused). Just as experimenting on a brain damaged human would be abuse - even if that person didn't know what was going on and didn't feel any pain. That is what I was referring to. Whatever you call it, it is wrong. Unless those animals volunteer.

 

No. What it will do is take away any "boost" and make the drug look less effective. Look, the placebo is an effect x. The drug has an effect y. Because of double blind and everyone thinking they have the drug, what we measure is y in the experimental group and x in the controls. The overall effect we see is y - x. So if x diminishes the apparent effect y.

 

As I explained above, I was originally referring to the placebo effect of drugs that are on the market. They are not being measured against a placebo.

 

Doesn't matter. The randomized double blind studies have already given us the real effect. The effect you are talking about only matters in those cases where randomized double blind studies have not been done, such as "herbal" medicines and nutritional supplements. There the entire effect could be due to what you describe.

 

I was referring to drugs already on the market. It was in reply to someone's reference to the wonders of drugs on the market. I said that those wonderful effects could be due to the placebo effect of those drugs.

 

Again, doesn't matter: because we already know the real effect from the clinical trials!

 

I was referring to drugs already on the market. It was in reply to someone's reference to the wonders of drugs on the market. I said that those wonderful effects could be due to the placebo effect of those drugs. If you give someone a drug - after all the clinical trials have been done and the drug has been on the market for some time - and tell them that it is a wonder drug, they will believe you. The drug will then have a placebo effect on them.

 

Your last statement has some assumptions:

1. It presumes that drugs that fail animal testing will pass clinical trials. Why would you think that?

2. You are assuming that all the failures in clinical trials are due to failures in animal testing. But as you noted, "I know that drugs can fail for commercial reasons." This destroys your assumption.

 

When the assumptions are wrong, the conclusions are going to be wrong.

 

I don't presume that drugs that fail in preclinical testing will pass in human testing. Some might. Some might not. I have never said, nor assumed, that all the failures in clinical trials are due to the failure of testing in other species. As I had no such assumption, presumption or consumption, my statement about commercial reasons cannot destroy such a non-assumption.

 

You are trying guilt by association. You know that is an invalid argument.

 

I know how much corruptiont there is. And I know human nature. I do believe there will be corruption in IACUCs. I have no proof. Yet.

 

You never demonstrated that. Please do so.

 

I have shown proof of their incompetence/negligence.

 

That does not follow. Since most time studies are not published because the data is negative -- no efficacy -- it means that publishing data that the drug was ineffective is not going to make the drug "succeed".

 

You quoted part of what I said and then replied to it without taking into consideration the full, original statement. I first mentioned a paucity of results in answer to your statement of: 'But of course the AR people are all saints, with no agenda and they would never distort the truth for their cause, would they?'

 

My reply to that was: 'There's no need for distortion. The paucity of reliable, accurate results in humans that come out of non-human tests speak loud and clear to anyone who will listen and who hasn't been deafened by the vile din of the vivisection propaganda.'

 

---------

Now, the part about 'paucity' referred to the fact that very few drugs succeed in clinical trials despite the many that go into clinical trials. There is a paucity. A paucity of 10%.

----------

 

You quoted me: 'The paucity of reliable, accurate results in humans that come out of non-human tests speak loud and clear to anyone who will listen and who hasn't been deafened by the vile din of the vivisection propaganda.'

 

And then you replied: 'All you have to do is a superficial PubMed search on ANY disease and drug to refute that "paucity of reliable, accurate results" claim. ALL the currently used treatments, and the ones that never made it to humans, went thru animal testing. All you have to do is go LOOK at the evidenced....'

To which I replied: 'I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans.'

 

When I said more drugs would succeed if there wasn't a paucity, I meant that if more drugs succeeded more drugs would succeed.

 

Again, why the double standard? You care a lot about the safety of animals and not to try drugs on them. But you have no similar care about the safety of your fellow human beings. Is it because you, by your own admission, take no drugs and therefore will not be one of those to test an unknown drug for safety? That seems very selfish on your part. You want drugs for human treatment -- even ones to treat you someday -- but you won't volunteer for safety testing.

 

Your above reply is to my statement about the unknown effects of drugs that have never been tested on humans. I was simply pointing out that it is not known how drugs that fail in the preclinical stages would have performed if given to humans.

 

I care about the safety of all animals, including humans. I want the best medical care for humans. They are not getting it.

 

They have "proper medical research". What they lack is

1. Adequate safety (which means VERY, VERY safe).

2. Commercial prospects.

 

David Graham of the FDA doesn't think it means very very safe. The 'proper' medical research is failing humans.

 

They had tested rodents as models for toxicity and they were very good models. Chemicals that were known to be teratogenic on humans were also teratogenic on rodents. It turned out that thalidomide was a tragic exception: it was not teratogenic in rodents but was in humans. However, thalidomide was teratogenic in primates (monkeys). But, in deference to animal rights people like you, testing in primates in Britain at the time was not done.

 

Thalidomide actually points to the danger of your position: animal models were skipped and look what happened. Now you want to skip ALL animal models and go directly to humans. If thalidomide was teratogenic at 1/100th the usual does, even pregnant women getting the microdose would have had deformed children. But you don't care about that, do you? As long as the animals are safe.

 

Were teratogenic studies done before the thalidomide tradegy? I don't suggest using the current microdose dosage for microdosing. 1/100 of the therapeutic dose is too high. I suggest using a-sixteenth of a thimbleful in 1 million gallons to start with. Or some such figure.

[iNow]

There's got to be some sort of "using far too many words and unnecessary legnth to try winning an argument" fallacy, right?

 

If you can't fit it on an index card, you don't understand what you're talking about.

[AtomSplitter]

The laboratories are required by law to make a record of all animals used, but the only records published are those that have recorded the number of vertebrates that have been tested upon. In actual fact scientists use fruit flies for the majority of their work so that larger animals do not suffer. animal testing has helped save the lives of millions of people and help elongate billions of peoples lives due to breakthroughs in medicine due to the testing.

Animal testing should be allowed to happen, if only for medical purposes.

[Mr Skeptic]

Are you seriously suggesting that scientists keep a record for fruit flies? Can you imagine the number of trees your idea would kill?

[AtomSplitter]

it would just be a single record, USE A COMPUTER!!!!!