The "Alternatives to Animal Research" Thread

[Bowwowmeow]

British Scientists Build a Model Gut


By MARIA CHENG (AP Medical Writer)
From Associated Press
November 10, 2006 10:36 PM EST
LONDON - British scientists have built what they say is the world's first artificial stomach: a shiny, high-tech box that physically simulates human digestion.
Constructed from sophisticated plastics and metals able to withstand the corrosive acids and enzymes found in the human gut, the device may ultimately help in the development of super-nutrients, such as obesity-fighting foods that could fool the stomach into thinking it is full.
"There have been lots of jam-jar models of digestion before," said Dr. Martin Wickham of Norwich's Institute of Food Research, the artificial gut's chief designer, referring to the beakers of enzymes typically used to approximate the chemical reactions in the stomach.
Wickham's patented artificial gut is a two-part model that is slightly larger than a desktop computer. The top half consists of a funnel in which food, stomach acids and digestive enzymes are mixed. Once this hydration process is finished, the food gets ground down in a silver metal tube encased in a dark, transparent box.
Software sets the parameters of the artificial gut - how long food remains in a particular part of the stomach, predicted hormone responses at various stages, and whether it is an infant or adult gut.
Unlike previous gut models, Wickham's model incorporates the physiological elements of digestion, including the stomach contractions that break up food and move it along the assembly line of human digestion.
The artificial gut is already attracting commercial attention.
One company wants to use it to test whether a biscuit can release a specific nutrient in the small intestine. Another group wants to determine if soil contaminants, which could potentially be swallowed by children playing outside, get absorbed by the human body.
The model gut's focus on the physical and chemical reactions that take place in the stomach promises to provide a more detailed understanding of food structure and its impact on digestion.
"This is an important tool that will allow us to understand what happens in the gut," said Dr. Peter Ellis, a biochemistry expert at King's College in London, who was not connected to the project.
Other artificial stomach models have largely neglected the connection between food structure and digestion, according to Ellis. "This model is important because it gets the science of digestion right," he said.
By understanding how food gets processed in the gut, and in which part of the stomach nutrients get absorbed, researchers may be able to develop foods designed to manipulate the digestive process, a strategy that would have broad implications for public health.
For instance, knowing how quickly glucose gets absorbed into the bloodstream could potentially help treat diabetes.
"Our knowledge of what actually happens in the gut is still very rudimentary," said Wickham, "but we hope that this model can help fill in some of the blanks."
Some experts say any artificial gut has inherent limitations.
"The stomach is an extraordinarily complex organ, so you cannot create a model that will undertake all of these functions," said Dr. Stephen Bloom, head of metabolic medicine at Imperial College in London, who was not involved in the project.
Still, Bloom said that looking at issues such as the breakdown of food and the role of enzymes in a model stomach is valuable.
"There are a number of questions that are very difficult to study in real life that could more easily be answered in the laboratory," he said, noting that using human volunteers to collect information about digestion is usually a costly and uncomfortable process.
With a capacity about half the size of an actual stomach, the artificial gut can "eat" roughly 24 ounces of food. To date, the most substantial meal it's enjoyed is vegetable soup.
"It's so realistic that it can even vomit," adds Wickham.
The model gut, which was funded by the British government, was built at a cost of approximately $1.8 million. Wickham and his colleagues are currently negotiating with about a dozen companies regarding future projects for the gut.


:yea: :yea: :yea:

[Oracl]

Excellent. :thumbsup:

[Gliondrach]

More money needs to be spent on developing methods that can be used to see what is likely to happen in the human body. Using non-human animals is unscientific and misleading. Some of the things that exist are chip-based systems that can have drugs put into them and that then circulate the drug through different compartments, simulating the metabolism of the drug in the body, and showing what will happen to it in the liver, etc. Then there are computer programmes that can find the best drug compound to treat a disease. Or that can show what a drug will do in virtual patients. There are imaging techniques which can show how a drug interacts with the body at the cellular level. More developments are taking place but there is not enough money being put into them.

[Keykeypie]

OH that is great news BOW! Thanks....I got to share this with a few more people:yea:

[Bowwowmeow]

I just hope new techniques come fast and thick so we can fill this thread up with good news for animals! :crossfingers:

[Bowwowmeow]

Heart Valves Grown From Womb Fluid Cells


By LINDSEY TANNER (AP Medical Writer)
From Associated Press
November 15, 2006 10:23 PM EST
CHICAGO - Scientists for the first time have grown human heart valves using stem cells from the fluid that cushions babies in the womb - offering a revolutionary approach that may be used to repair defective hearts in the future.
The idea is to create these new valves in the lab while the pregnancy progresses and have them ready to implant in a baby with heart defects after it is born.
The Swiss experiment follows recent successes at growing bladders and blood vessels and suggests that people may one day be able to grow their own replacement heart parts - in some cases, even before they're even born.
It's one of several sci-fi tissue engineering advances that could lead to homegrown heart valves for infants and adults that are more durable and effective than artificial or cadaver valves.
"This may open a whole new therapy concept to the treatment of congenital heart defects," said Dr. Simon Hoerstrup, a University of Zurich scientist who led the work, which was presented Wednesday at an American Heart Association conference.
Also at the meeting, Japanese researchers said they had grown new heart valves in rabbits using cells from the animals' own tissue. It's the first time replacement heart valves have been created in this manner, said lead author Dr. Kyoko Hayashida.
"It's very promising," University of Chicago cardiologist Dr. Ziyad Hijazi said of the two studies. "I don't doubt" that it will be applied one day in humans, he said.
One percent of all newborns, or more than 1 million babies born worldwide each year, have heart problems. These kill more babies in the United States in the first year of life than any other birth defects, according to the National Institutes of Health.
Heart valve defects can be detected during pregnancy with ultrasound tests at about 20 weeks of pregnancy. At least one-third of afflicted infants have problems that could be treated with replacement valves, Hoerstrup said.
"It could be quite important if it turns out to work," said Dr. Robert Bonow, a Northwestern University heart valve specialist.
Conventional procedures to fix faulty heart valves all have drawbacks. Artificial valves are prone to blood clots and patients must take anti-clotting drugs for life. Valves from human cadavers or animals can deteriorate, requiring repeated open-heart surgeries to replace them, Hijazi said. That's especially true in children, because these valves don't grow along with the body.
Valves made from the patient's own cells are living tissue and might be able to grow with the patient, said Hayashida, a scientist at the National Cardiovascular Center Research Institute in Osaka.
The Swiss procedure has another advantage: using cells the fetus sheds in amniotic fluid avoids controversy because it doesn't involve destroying embryos to get stem cells.
"This is an ethical advantage," Hoerstrup said at the meeting.
Here's how the experiment worked:
Amniotic fluid was obtained through a needle inserted into the womb during amniocentesis, a prenatal test for birth defects that is often offered to pregnant women aged 35 and older.
Fetal stem cells were isolated from the fluid, cultured in a lab dish, then placed on a mold shaped like a small ink pen and made of biodegradable plastic. It took only four to six weeks to grow each of the 12 valves created in the experiment.
The researchers said lab tests showed they appeared to function normally.
The next step is to see if they work in sheep, a two-year experiment that Hoerstrup said is under way.
He and co-researcher Dorthe Schmidt called their method "a promising, low-risk approach enabling the prenatal fabrication of heart valves ready to use at birth."
Hoerstrup said amniotic stem cells also can be frozen for years and could potentially be used to create replacement parts for aging or diseased valves in adults, too.
The research is preliminary and experts say implanting tissue-engineered human valves in human hearts is likely years away. But it's not as far-fetched as it sounds.
Earlier this year, U.S. scientists reported re-engineering seven diseased bladders with tissue grown from the patients' own cells.
And last year, researchers reported that two kidney dialysis patients from Argentina had received the world's first tissue-engineered blood vessels, fashioned from their own skin and vein tissue.
Dr. John E. Mayer Jr., a Children's Hospital Boston heart surgeon and tissue engineering pioneer, said scientists are optimistic that this area of research will revolutionize how people with valve disease will be cared for in the future.
About 250,000 patients worldwide have surgery to replace heart parts each year, according to Mayer.
In one of Mayer's experiments, heart valves fashioned from stem cells harvested from sheep bone marrow appeared to function normally when implanted in sheep. A similar experiment used cells harvested from sheep arteries.
Hoerstrup said amniotic fluid is potentially a richer source of stem cells than other sources.
Mayer said the big question is whether stem cells from amniotic fluid can create valves superior to those made from other cell types.
"I'm pretty sure the ball will continue to be advanced down the field," Mayer said. "We'll get there one way or the other."
---
On the Net:
NIH: nhlbi.nih.gov/health/dci/Diseases/chd/chd_what.html
American Heart Association: heart.org


Hopefully they'll be leaving the sheep alone in the future.

[Keykeypie]

Virtual patients help drug-testing efficiency, replace animals


Silicon Valley/San Jose Business Journal - February 2, 2007

by Lynn Graebner

A Foster City life sciences company says its virtual version of the laboratory mouse is making new-drug development faster, cheaper and more efficient -- and is even more important as companies deal with new European Union rules against animal testing.

Entelos Inc., which has been working for the past decade on computer models that create virtual patients, has supplied Unilever -- maker of products like Dove soap and Pond's lotion -- with a computer model that simulates skin sensitization. Unilever will use the technology in an effort to comply with an EU mandate that by Mar. 11, 2009, cosmetic ingredients sold there cannot be tested on animals.


Entelos president and CEO James Karis anticipates more business might come the company's way as other consumer products companies selling in the EU look at ways to comply with the ban.

"We have a lot of discussions going on [with other companies]. Clearly this announcement was noticed," he says. "This is our first involvement outside of the pharmaceuticals."

Pfizer Inc. of New York is also a partner of Entelos. "We are continually exploring ways to, one: minimize animal use with the hope of someday eliminating the need to use them entirely and, two: identify and affirm the attributes and side-effects of potential new drugs early in the R&D process, which involves 10 to 15 years," says Kate Robins, a Pfizer spokeswoman.

To date Entelos has been building computer models of various diseases such as cardiovascular disease, asthma, obesity, diabetes and rheumatoid arthritis. "What we're building here are mathematical representations of human biology," Karis says.


On Jan. 23, the company announced it had completed its computer model for simulating cholesterol regulation, plaque build-up in arteries and cardiovascular risk. Entelos reports it is working on research in this area with three large, but unnamed, pharmaceutical companies. The list of partners it has named includes heavyweights such as Abbott, AstraZeneca International, Sanofi-Aventis, Bayer AG, Bristol Meyers Squibb, Eli Lilly, Johnson & Johnson Pharmaceutical Research & Development, LLC, Novartis, Procter & Gamble, Roche and Unilever.

"We started looking at Entelos in 1998 when the genomics era was starting," says Richard Ho, director of disease simulation for J&J in La Jolla. Using a mathematics approach to treating diseases was new to J&J. "We were used to using a few genes at a time. These guys were using all the genes," Ho says.

He describes the approach as "reverse engineering," dissecting how a body becomes diseased. While other companies and academic institutions are using a similar approach to disease research, "this company brings it together in a way that's easy for this company [J&J] to apply," Ho says.

"Lots of pharma companies are using their technology," says Richard Kahn, chief scientific and medical officer at the American Diabetes Association (ADA). "We think their technology is pretty unique. We've had a longstanding relationship with them on many issues." In fact, Entelos and ADA have formed an initiative called the Diabetes Research Center and plan to fund research institutions who want to use Entelos' technology to study the onset, progression and treatment of diabetes.

"They've [Entelos] got this technology and we want people to use it and we're willing to support the academic investigators," Kahn says. DRC will start issuing grants in July, he says. "By utilizing Entelos' virtual patient approach to predict drug effects in concert with our preclinical and clinical data, we hope to more effectively identify the best compounds to move into clinical testing," says Darien Wilson, director of public affairs at Roche.

Entelos' technology is designed to help companies avoid the expensive failures which have made the cost of getting a new drug to market to hit $1 billion in some cases, and drawn the process out to as many as 12 years. Entelos is working to help companies determine which drug
candidates might have the greatest impact on a disease, what dosage would be safe for humans, which patients would be best suited for the clinical trials, how the drug compares to competitors' products and if it might be useful to treat other ailments.

Earlier this month Entelos purchased an option for an early stage drug compound from Johnson & Johnson Pharmaceutical Research & Development LLC. The company say s this is one example of its strategy to use its disease simulator systems to raise revenue for buying rights to drugs.
Karis says the company would like to take some drugs to final phase three clinical trials and then partner them out to large pharma companies. That's about the point in development when pharma companies are interested, he says.

[Charmagne]

I hope and pray this works well for all the drug and cosmetic companies so as to do away with animal testing. These animals are born in a cage, tortured and die in a cage. This is great news - I hope all companies using animals step up and try "virtual patients". As the article says it would cut their losses and money is what they are all about.

[Fauxmage]

Foster City is only a few miles away from where I live. Maybe I should go shake their hands in thanks. :yea:

[Gliondrach]

Great news. Much more money needs to be spent on these things.

[Oracl]

Excellent news. :agree:

[Gliondrach]

Not research, but related.

I didn't know that so many US medical schools no longer require students to use live animals. But there are still some. And I didn't know that some osteopathic medical schools have live animal laboratories.



Alternatives to Animal Labs in Medical Schools
The Physicians Committee for Responsible Medicine is winning its campaign to institute alternatives to the use of animals in medical school education. Twenty years ago, live dogs were commonly used in physiology, pharmacology, and surgery courses at medical schools. A standard laboratory exercise involved anesthetizing a dog, followed by injecting pharmaceuticals or practicing surgical techniques. The animal was typically killed after the laboratory.

Today, more than 85 percent of medical schools in the United States have eliminated live animal laboratories from their curricula. Innovations in medical simulation technology, availability of alternatives, increased awareness of ethical concerns, and a growing acknowledgement that medical training must be human-focused have all facilitated this shift.

Today, 14 medical schools (of 125) continue to use live animals in elective courses. Medical faculty, practicing physicians and PCRM members know that students do not need to train on live animals to become successful physicians.

Are you a medical student, parent of a medical student, medical school alumnus, physician, professor, faculty, or do you know someone who is at a medical school that offers live animal labs? (Here is a list of medical schools with live animal labs.)

http://www.pcrm.org/research/edtraining/meded/medical-schools-with-live-animal-laboratories

Everyone:

Write letters to the dean of one of the medical schools still using live animals in its curriculum.
Write letters to local newspapers expressing your concern over the medical school’s continued use of live animals in its curriculum.
Distribute flyers on the medical school campus to help us recruit sympathetic medical students and faculty (contact Ryan Merkley at rmerkley@pcrm.org).
Pass along this list and ask friends, family and acquaintances to help out.

pcrm.org/resch/meded/index.html

[Gliondrach]

Lots of good info about research:

www.safermedicines.org/newsletters/newsletter07-summer.pdf

[Gliondrach]

This is good. I particularly like the paragraphs near the bottom , numbered 4,5,and 6.


Response published in “Oxford Magazine”, Trinity Term 2006

I Protest Against Bad Arguments – Do You?

An Oxford philosophy tutor

Old habits die hard, as Merleau-Ponty famously observed (though in many more words, and in French, of course). When I see an essay written (if only in part) by PPE students, past and present, students who by that very fact will have studied logic for their prelims, the red pen irresistibly wriggles out and corrects the logic of their arguments<1>. These comments on their essays must seem terribly dull, and the mistakes pointed out terribly obvious; the dulness perhaps I cannot help, but as for the obviousness, I comfort myself with the thought that if the mistakes were that obvious then they would not keep re-appearing, not just in essays but in published works (e.g., the recent article `I am Pro-Test: are you?', OM Fourth Week Trinity Term 2006 p. 15)<2> and in public meetings (e.g., Pro-Test's Open Meeting at the Town Hall on 21st May) – though should one assume that people do not knowingly put forward bad arguments?

1.
What does Pro-Test stand for? The name seems to suggest that they are simply in favour of animal testing. Yet according to the article the `professors, lecturers, [and] graduate and undergraduate students' who form the Pro-Test committee `agreed that it was important to take a stand in solidarity with Oxford researchers and in defence of academic freedom, science in general and vivisection in particular'. This sounds like four aims, not one, only the last of which is signalled in the name of the group, and they are separable.<3>

The `stand of solidarity' seems to be understood as a stand against the tactics of a tiny minority of extremists. We are explicitly asked to lie, as the slaves lied for Spartacus, in support of this aim, whence the title of their article, but leave that aside. Leave aside too the somewhat question-begging identification of Oxford researchers with the oppressed slaves. (Opponents of animal testing might be more apt to place the laboratory animals in this role.) The point is that it is surely possible to object to threats and intimidation directed against said researchers without being in favour of vivisection.

The reference to academic freedom is clearly a red herring. No-one thinks that there should be no ethical limits on academic freedom. E.g., no-one would, I take it, defend medical experimentation on prisoners without their informed consent, or on impoverished inhabitants of the Third World paid for their participation, on the grounds of academic freedom. The issue is not whether one is for or against academic freedom but what the ethical limits on such freedom should be.

The reference to `science in general' is also a red herring. Quite apart from the fact that researchers in the physical sciences and many of those in the life sciences have nothing to do with vivisection in their work, there is clearly scope for debate even among life scientists about the scientific merits of vivisection for the development of drugs to be used on humans. After all, there appear to be scientists on both sides of the vivisection debate.

Of course there is nothing wrong with an organisation's having multiple aims, as long as everyone is clear that to be in favour of the organisation is to support all four aims and that to be against it is not necessarily to be against all four aims. There is a serious risk of confusion, however: though I would like to think that none of my colleagues is vulnerable to such a confusion, some conversations have led me to suspect that there were people who went on the original Pro-Test march not because they were in favour of animal research but because they objected to the tactics of some of the animal rights `extremists'. And there is a live danger that people within the University who distance themselves from Pro-Test because they reject the aim implied by its title will be understood as being in favour of intimidatory tactics directed against our beleaguered colleagues, against academic freedom, and anti-science. Cynics may ask: did Pro-Test deliberately invite this confusion by including this diverse set of aims under its umbrella?

2.
Inconsistencies regarding ends and means. `We know that without animal research, medicine as we know it today wouldn't exist' (OM article). (Bizarrely, the literature handed out at the Open Meeting included the example of the eradication of smallpox as one of the triumphs of animal research.) No anti-vivisectionist would dream of disputing the fact that animal research was one of the means by which modern drugs were developed; but even if one accepts the worthiness of the end – which, I take it, is not itself incontestable -- most of us, whether pro- or anti-vivisection, reject the principle that the end justifies the means. That most people reject this principle does not make it false; but to presuppose it at one moment and reject it at another does entail logical inconsistency. And Pro-Testers are quite prepared to decry the apparent reliance on this principle by their `extremist' opponents. Of course it could be argued that if the end is good enough, it justifies the means; but here we suddenly find that what was masquerading as a dispute about a general principle or about its consistent application has mutated into a dispute about ends, which logic of course has no means of resolving.

3.
The numbers game (1). At the Open Meeting, the Regius Professor of Medicine stressed once again that less than 5% of the animals to be used for research at the Animal House will be primates.<4> A colleague recently told a story at lunch about a committed vegetarian friend of hers who asked for a vegetarian meal in a restaurant in France; she was brought a quiche Lorraine. When she objected that there was bacon in it, she was told, `Oui, madame, but the pieces of bacon are very small'. If something is wrong, then it is wrong, even in very small pieces.

4.
The numbers game (2). It was suggested during the discussion at the Open Meeting that if the animal activists `really cared' about animal welfare, they would be advocating vegetarianism, protesting against hunting, opposing factory farming and combatting the inhumane treatment of dogs in the Philippines rather than trying to stop animal experimentation, where the numbers are much smaller. Leave aside the fact that many opponents of vivisection undoubtedly do these things as well; the numbers game can be played by both sides. It could equally be argued that if the medical researchers `really cared' about human welfare, they could boost human health on a far greater scale worldwide by attempting to combat poverty, malnutrition and poor education in the Third World and elsewhere rather than developing new drugs.

5.
Problems of scientific method. We are told that animal testing `saves lives'. (Presumably human lives?) Part of the argument is that human beings would be more likely to receive ineffective or unsafe drugs if these were not tested on non-human animals first. Perhaps someone will correct me on this, but demonstrating comparisons such as `more likely' would seem to require having both sides of the comparison; hence on the face of it, this claim could only be demonstrated if drugs which were shown to be effective on and safe for animals were more likely to be effective on and safe for humans than either drugs not tested on animals at all or drugs tested on animals and shown to be ineffective or unsafe. Yet we have no such demonstration: drugs not tested on animals, or tested on animals and found to be ineffective or unsafe, are never tested on humans. Hence we lack one side of the comparison. I will await the scientists' explanations as to why such a direct comparison is unnecessary.

6.
Using propaganda while condemning propaganda. The Pro-Test committee refers to `the sight of big-eyed kittens with electrodes in their heads', i.e. the sorts of images that some animal activists use in their literature, as `propaganda'; I take it that they mean something like `appeals to the heart rather than to the head', together with a condemnation of such emotive tactics. But if such tactics are to be condemned, then the Pro-Testers ought in consistency to refrain from such tactics. Yet one of the speakers at the Pro-Test Open Meeting was the mother of a child with a rare form of muscular dystrophy offering her `personal perspective', expressing the hope that through animal testing, one day a cure would be found for his condition. However much we might sympathise, such stories are no less `propaganda' than the pictures of electrode-ridden kittens. That such appeals are not wholly directed `to the head' is demonstrated by the testimony in the recent Channel 4 Dispatches programme on the animal rights movement (`Mad about animals', 15 May 2006) from a woman whose extremely painful condition moved her to empathise with the suffering of laboratory animals and hence to speak out against vivisection. Thus comparable human tragedies can lead the sufferers in opposite directions vis-à-vis animal research. (It is noteworthy in this connection that pro-vivisectionists never seem to use pictures of `big-eyed kittens with electrodes in their heads' in support of their cause.)

The really important issues here are ones which logic has no power to resolve. This seems not a good reason for giving up the use of logic altogether when discussing them.


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

<1> It goes without saying that should any philosophy student, past or present, who therefore studied logic in their first year, put forward equally bad arguments on the other side, it would be equally disturbing to a philosophy tutor.
<2> An almost identical version of this article, minus the Spartacus analogy, appeared in the Summer 2006 edition of RDS [Research Defence Society] News.
<3> The so-called People's Petition (www.thepeoplespetition.org.uk), recently famously signed by Tony Blair, invites the same confusion: to sign it is simultaneously to commit oneself to three things: that medical research requires some studies that use animals, that researchers should continue to use animal testing where there is no alternative available, and that people in medical research using animals have the right to live and work without fear of intimidation or attack.
<4> Note that this argument only works against those anti-vivisectionists who suppose that vivisecting primates is worse than vivisecting other animals. Colin Blakemore, the chief executive of the Medical Research Council, has been in the news recently for suggesting that there might be circumstances in which the current blanket ban on the use of great apes in medical research might properly be lifted (Guardian, 3 June 2006). BUAV (British Union for the Abolition of Vivisection) has responded by calling for the blanket ban to be extended to all primates.

vero.org.uk/press5.asp

[Bowwowmeow]

It could equally be argued that if the medical researchers `really cared' about human welfare, they could boost human health on a far greater scale worldwide by attempting to combat poverty, malnutrition and poor education in the Third World and elsewhere rather than developing new drugs.
Haha! Excellent!

Using propaganda while condemning propaganda. The Pro-Test committee refers to `the sight of big-eyed kittens with electrodes in their heads', i.e. the sorts of images that some animal activists use in their literature, as `propaganda'; I take it that they mean something like `appeals to the heart rather than to the head', together with a condemnation of such emotive tactics. But if such tactics are to be condemned, then the Pro-Testers ought in consistency to refrain from such tactics. Yet one of the speakers at the Pro-Test Open Meeting was the mother of a child with a rare form of muscular dystrophy offering her `personal perspective', expressing the hope that through animal testing, one day a cure would be found for his condition. However much we might sympathise, such stories are no less `propaganda' than the pictures of electrode-ridden kittens. That such appeals are not wholly directed `to the head' is demonstrated by the testimony in the recent Channel 4 Dispatches programme on the animal rights movement (`Mad about animals', 15 May 2006) from a woman whose extremely painful condition moved her to empathise with the suffering of laboratory animals and hence to speak out against vivisection. Thus comparable human tragedies can lead the sufferers in opposite directions vis-à-vis animal research. (It is noteworthy in this connection that pro-vivisectionists never seem to use pictures of `big-eyed kittens with electrodes in their heads' in support of their cause.)

Absolutely. There's nothing logical or ethical about placing greater value on sick human babies. Its 100% pure emotion. If we are to be condemned for being inspired by our emotions for suffering animals, so should they for their emotional appeals involving sick children.

[Gliondrach]

This was on the A LF forum:

Flaws in use of animal tests for new drugs

By Clive Cookson in York

Published: September 14 2007 17:39 | Last updated: September 14 2007 17:39
The use of animal tests in drug development is fundamentally flawed, according to new evidence presented at the BA (British Association for the Advancement of Science) Festival of Science in York on Friday.

As a result, many animal studies “overstate how effective drugs really are”, said Malcolm Macleod, a consultant neurologist at Edinburgh university. These drug candidates then fail to work when given to humans in clinical trials – and could even put patients’ health at risk. The main issue is experimenters’ unconscious bias. Researchers do not routinely divide animals at random into treatment and control groups and, when they analyse results, they know which animals have been treated and which have not.

Dr Macleod heads an international consortium called Camarades, which analyses animal testing of treatments for stroke. This condition makes a good case study, because there is an appropriate “animal model” that mimics human stroke in rats and mice, and because researchers have published many comparable animal studies of the same stroke treatment.

“Over 800 drugs have been tested in animal models of stroke and about 500 of these seem to work in animals,” said Dr Macleod. “Nearly 100 of these have been tested in people and – with one exception (tPA) – they don’t work in patients with stroke.”

Researchers who “randomised” animals before treatment – and were “blinded” to the allocation of animals – reported much less favourable results than the majority who failed to design their experiment in this way. A recent study of 100 animal studies of six stroke treatments found that only 36 per cent were randomised and 11 per cent were blinded. Yet randomised, blinded trials are routine in clinical trials with humans.

Dr Macleod also reported the results of an investigation into NXY-059, AstraZeneca’s experimental stroke treatment. The company dropped NXY-059 when it showed no benefit in a clinical trial involving more than 3,000 patients, after very promising animal studies.

Overall, NXY-059 improved outcome in animals with stroke by 44 per cent, Dr Macleod said: “However, when we looked in more detail, disturbing patterns appeared.”

For example, studies that did not randomise animals said NXY-059 improved outcome by more than 50 per cent; those that did not estimated the effect at only 20 per cent. Studies that did not blind the assessment of outcome said it improved that outcome by almost 50 per cent; those that did not estimated the effect at less than 30 per cent.

“We have reported similar findings for other interventions, but what is disturbing about the data for NXY-059 is that for a drug where most of the published work was funded by the drug manufacturers the impact of poor study quality was much more pronounced,” said Dr Macleod. He emphasised that he was not opposed to animal experiments – indeed he uses them in his own work – but wanted them to be designed to the same high standard as human clinical trials.

Derek Fry, a senior Home Office animal inspector, and Simon Festing, head of the Research Defence Society, agreed there was scope to improve experimental procedures.

“Those of us defend animal research accept that there is a problem here,” said Dr Festing.

[Fauxmage]

Researchers Seek Animal Test Alternative

By MICHAEL HILL
Associated Press Writer

TROY, N.Y. (AP) -- The lab rat of the future may have no whiskers and no tail - and might not even be a rat at all.

With a European ban looming on animal testing for cosmetics, companies are giving a hard look at high-tech alternatives like the small, rectangular glass chip professor Jonathan Dordick holds up to the light in his lab at Rensselaer Polytechnic Institute.

The chip looks like a standard microscope slide, but it holds hundreds of tiny white dots loaded with human cell cultures and enzymes. It's designed to mimic human reactions to potentially toxic chemical compounds, meaning critters like rats and mice may no longer need to be on the front line of tests for new blockbuster drugs or wrinkle creams.

Dordick and fellow chemical engineering professor Douglas Clark, of the University of California, Berkeley, lead a team of researchers planning to market the chip through their company, Solidus Biosciences, by next year. Hopes are high that the chip and other "in vitro" tests - literally, tests in glass - will provide cheap, efficient alternatives to animal testing.

No one expects the chips to totally replace animals just yet, but their ability to flag toxins could spare animals discomfort or death.
"At the end of the day, you have fewer animals being tested," said Dordick.

Medical advances ranging from polio vaccines to artificial heart valves owe a debt to legions of lab rats, mice, rabbits, dogs monkeys and pigs. Animals - mostly mice - are still routinely used to test the toxicity of chemical compounds.

Animal testing also still has an essential role in making sure new pharmaceutical products are safe and effective for humans, said Taylor Bennett, senior science adviser to the National Association for Biomedical Researchers. Animal studies generally are needed before the federal Food and Drug Administration will approve clinical trials for a drug.

"The technology is not yet there to go from idea to patient application without using animals," Bennett said.

Animal testing can be slow, though, and some researchers question how well an animal's response to a chemical can predict human reactions.
In addition, the public is increasingly queasy about animal testing, especially the idea of inflicting pain for products like new lipsticks or eye shadows. The movement against animal testing has been especially strong across the Atlantic, where the European Union is set to enact its ban on animal testing for cosmetics in March 2009.

Cosmetics companies have greatly reduced animal testing, though they still may use it to test the safety of a new ingredient, said John Bailey, executive vice president of the Personal Care Products Council, an industry group.

Alternatives to animal tests include synthetic skin substitutes and computer simulations. But in vitro products show the most promise because they can are efficient, fast and easy to manipulate, said Dr. Alan Goldberg, director of the Center for Alternatives to Animal Testing at Johns Hopkins University.

"There's no question that it's the strategy of the future," Goldberg said.
Bailey agrees that in vitro chips hold the most promise, but said the chips still need to be validated before companies can have more confidence in them. He noted that chips have limitations when it comes to risk assessment, such as determining if particular doses of a substance pose a cancer risk.

The product developed by Dordick and Clark consists of two glass slides. The first, called the MetaChip, has rows of little blots containing human liver enzymes. The other slide, the DataChip, contains an identical array of blots which, depending on the test, could be live human bladder, liver, kidney, heart, skin or lung cell cultures. Sandwiched together, the two chips mimic the human body's reaction to compounds.

If the cells die or stop growing, it's a sign that a toxin was present.
Troy-based Solidus has received about $3 million in federal money, including grants from the National Institutes of Health and the National Science Foundation. Dordick said a pharmaceutical company and a cosmetic company are testing the chip and they hope Solidus will have a product on the market by late 2009.

Goldberg notes that the movements toward in vitro and away from animal testing is incremental - even optimistic assessments measure progress in decades. But he still believes there may well be a day when the lab rat becomes a thing of the past.

"At some time in the far future my suspicion is yes," he said, "because we're doing it stepwise by stepwise."
---
On the Net:
Rensselaer statement: http://tinyurl.com/2ym6tn

[Gliondrach]

Someone said:

"There's no question that it's the strategy of the future," Goldberg said.
Bailey agrees that in vitro chips hold the most promise, but said the chips still need to be validated before companies can have more confidence in them. He noted that chips have limitations when it comes to risk assessment, such as determining if particular doses of a substance pose a cancer risk.



I wonder how will they validate them? Using various animals? But the animals used in vivisection nearly always get it wrong when they test drugs for safety and efficacy. They need to be validated properly - using humans.

[VeganD]

Click on Watch Safer Medicines

http://www.curedisease.net/safermedicines/index.shtml

[Bowwowmeow]

Thanks for that VeganD. :)
We already have a thread for this, so I merged your thread with it.

[Gliondrach]

Yes, that's a good one.

[Gliondrach]

16 May 2008

I am not a mouse

New report by US scientists exposes irrelevance of GM mouse research

Does a mouse effectively represent you in medical research? After decades of genetics research on mice, that has always assumed a specific gene in a mouse is the same as the equivalent gene in a person, scientists are now beginning to realise that the genes often don’t match up.

This assumed match is the basis for a huge amount of research using many millions of genetically modified (GM) mice. Scientists select a human gene of interest, then ‘knock out’ its equivalent in a mouse to see what happens, and thereby, they say, ascertain the function of the gene in people.

But researchers from the University of Michigan in the USA have recently published work revealing that this entire assumption is wrong. They took 120 genes that are absolutely essential to survival and reproduction in humans and looked at data where the genes had been knocked out in mice so that they couldn’t function. If the 120 genes involved were equivalent in
humans and mice, the knockout mice would have died or at least been unable to reproduce.

However, they discovered that 22% of the so called ‘essential genes’ in humans weren’t essential in mice. This shows that identical genes behave differently in mice and humans and throws further serious doubt on the whole basis for GM mouse research.

So what’s the alternative? The Dr Hadwen Trust has long suspected that equivalent genes in humans and mice don’t have the same effect, and last year we had a special call to find projects that replace GM mice in research.

One very promising grant that arose from this is being conducted by researchers at the University of York. This project involves ‘knocking out’ genes in donated human tissues in the laboratory. The researchers take donated human tissue such as bone marrow and extract a special type of cell called mesenchymal stem cells. These cells have the ability to turn into many different types of cell in the test-tube including bone, cartilage and fat cells.

The researchers then knock out specific genes in the mesenchymal stem cells before growing them into 3-D structures of the selected cell type. This allows the scientists to see the effects of the gene knockout in human tissues, so there’s no need to worry about species differences. Vital work like this can provide the type of alternative approaches that are essential if animals are to be replaced in the laboratory, and has the potential to save countless animals’ lives.

http://www.drhadwentrust.org/news/i-am-not-a-mouse

[Oracl]

Trillian and Co will be pleased when I tell them about this. :agree:

:mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse: :mouse:

[Gliondrach]

They are safe from the torturing scum.

[Oracl]

:agree:

[Tails4wagging]

In todays Independent newspaper the scientists have said they have found a cure for cancers in mice by using the white blood cells to fight it (cant remember anymore!). They now want humans to try it .

So false science isnt it?.

[Gliondrach]

The fools often find cures for cancer in mice. And then get no further.

[Tails4wagging]

What sickens me is that my disabilty has a support website and also scientists have genetically modified mice to have this disabilty and the support website has a advert for donations with a caption of a mouse and words sayig give your mouse a heart (meaning computer mouse). Isnt that just sick!!??

[Gliondrach]

Yes. I wonder if they've seen the article that the Hadwen Trust have on their website, as mentioned above?

[Tails4wagging]

Ive just crossposted it on the website and asked for comments..:)

[Gliondrach]

Someone will probably say that valuable lessons could be learned by studying mice and that a breakthrough could occur at any time.

Instead of wasting time and money torturing mice they should be investing all that in studying humans.

[Tails4wagging]

Someone will probably say that valuable lessons could be learned by studying mice and that a breakthrough could occur at any time.

Instead of wasting time and money torturing mice they should be investing all that in studying humans.


Yes, no doubt they will. :hbang:

[Tails4wagging]

This is the one reply I got so far!!

jackie

Joined: 15 May 2008
Posts: 281
Location: England
Posted: Sun Jun 29, 2008 4:17 pm Post subject: Dr Hadwyn Trust

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

drhadwentrust.org/news/i-am-not-a-mouse


Comments?.

Back to top


Retlaw



Joined: 30 Jun 2006
Posts: 754

Posted: Sun Jun 29, 2008 11:57 pm Post subject: Dr Hadwyn Trust

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

I think primates more closely resemble humans, and there has been this research done on them for CMT. But mice can breed much quicker and are obviously easier to study in a lab than chimps, orangs, etc. Mice are essential to CMT research. Look at NT-3 or the Vit. C research for example.
_________________
Current CMT news is always on tap at CMTUS.
cmtushope.info

charcot-marie-tooth.org/forum/viewtopic.php?t=1612



This is from the other site.cmtushope.info/ MEMBERSHIP ONLY SITE.

[Oracl]

Sad. :shakehead:

[Gliondrach]

I don't know what the vitamin C research is but couldn't they have done it in humans? Fed some to different groups, different amounts.

Rearchers love to use mice because, as that poster said, they are easy to handle and breed quicker - which means more research papers can be written than if using primates or dogs. More research papers equals more funding and a job for life.

[Gliondrach]

From the Hadwen Trust.

21 July 2008
Animal experiments reach 3 million animals for first time in 16 years

Labour’s legacy for lab animals “an appalling failure”, say campaigners.

Home Office statistics1 released this week (21 July 2008) reveal that Britain’s animal experiments have reached over 3 million animals for the first time in 16 years, a rise of 21% since Labour came to power in 1997. The Dr Hadwen Trust, the UK’s leading non-animal medical research charity, has condemned the rise in its report Let Down By Labour2 which estimates that the government has saved just 2,236 animals per year through its reforms and, in effect, spends only 40p on non-animal replacement research for every animal used in a British laboratory.

There were 3.2 million animal experiments3 started in Britain in 2007, more than any other member state in Europe4 . Significant statistics include:

• 6.3% rise in animal experiments since 2006 and 21% increase since Labour came to power
• 11% rise in procedures on GM animals since 2006 and 157% rise since 1998
• 3,125 monkeys used in experiments in 2007; 5,648 dogs; 179 cats
• 1.4% increase in primate experiments since 1998
• 61% of procedures conducted without any form of anaesthesia whatsoever

In its report Let Down By Labour, the Dr Hadwen Trust demonstrates how Labour’s legacy for laboratory animals has been a severe disappointment and dominated by token gesture policies that have had a minimal impact. Since coming to power in 1997, the pledges contained in their pre-election manifesto ‘New Labour: New Life for Animals’ have largely ended tests that were either virtually finished in Britain anyway or not listed separately in official records, meaning their impact is unquantifiable. For example, the 1997 bans on great ape research and tobacco product testing saved no animals at all in real terms, as no animals were being used for such testing at the time. The ban on cosmetics testing, whilst a significant moral victory, only resulted in the ending of 590 animal procedures as such testing had virtually ended in Britain by the time of the ban.

Labour’s legacy for lab animals 1997 – 2008 (from Let Down By Labour2 ) :

A mere 2,236 animals estimated to have been saved each year as a result of Labour initiatives5
21% increase in overall animal experiments since 1997
532,239 more animals used in British labs each year
Virtual doubling of MoD experiments on animals at Porton Down
An estimated 40p spent on replacement research by government for every animal used in a UK lab, in 2006
The equivalent of just 7.8 seconds on average spent by Home Office Inspectors checking on each laboratory animal
Only 15% higher government replacement research spending than the main alternatives charities
0.00002% of Britain’s science budget spent on government funding of non-animal replacements
The Dr Hadwen Trust’s Wendy Higgins says:
“In 1997 animal welfare tokenism may well have been a vote winner for Labour. But it has resulted in an eleven year record of failure that has now seen the number of animals dying in British laboratories reach three million for the first time in 16 years. If the government doesn’t take urgent action to implement a clear strategy to replace animals with advanced techniques, Labour’s legacy for lab animals will be an appalling failure. With the latest independent review of animal research revealing a success rate no better than tossing a coin, such high levels of suffering are inexcusable.”

Increasingly, independent reviews of animal research efficacy published in journals such as Nature and the British Medical Journal (BMJ), reveal that animal tests have limited applicability to humans. The most recent, Comparison of treatment effects between animal experiments and clinical trials, by Professor Ian Roberts (London School of Hygiene and Tropical Medicine) was published in the BMJ in 20076. It concluded that from a total of 221 animal studies (using over 7,100 animals) half of the animal results failed to correctly predict the human outcome. A 50% success rate is about as useful as tossing a coin.

Click here to download the Dr Hadwen Trust’s PDF report Animals in Laboratories: Let Down By Labour

Click here to download our full summary of the 2007 statistics

Notes to Editor

1 Home Office. (2008). Statistics of Scientific Procedures on Living Animals: Great Britain 2007. London, England: The Stationery Office

2 Animals in Laboratories: Let Down By Labour published in PDF July 21 2008 by the Dr Hadwen Trust – PDF available on request.

3 Total procedures: 3,201,581, an increase of 6% from 2006 (The recent trend of increase: 2.73 million animal experiments in 2002; 2.79 million animal experiments in 2003; 2.85 million in 2004; 2.9 million in 2005 and 3.01 million in 2006).

4 Latest statistics declared from each Member State reveal Europe’s top three for animal experiments: First Britain with 3,201581 (2007) followed by Germany with 2,412678 (2005) and third France with 2,325,398 (2004).

5 Calculations based on bans since 1997 on animal testing for cosmetics, alcohol & tobacco products, offensive weapons, the oral LD50 test and procedures using great apes. Let Down By Labour, Dr Hadwen Trust, 21 July 2008.

6 P Perel et al (2007).Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ. 334:197.

http://www.drhadwentrust.org/non-animal-research/publications

drhadwentrust.org/file_downloads/76
You'll then need to enlarge it to 100%.

[Gliondrach]

22 January 2009
Replacing laboratory primates in Europe 'a matter of moral and scientific urgency' says Dr Hadwen Trust

An Opinion on primate experiments published this week by the EU’s Scientific Committee on Health & Environmental Risks1 (SCHER) has been heavily criticised by the Dr Hadwen Trust for Humane Research. The charity says SCHER has failed to take account of scientific evidence of the limitations of primate research and downplayed the potential of advanced alternative techniques. The Dr Hadwen Trust2, says it may be an ‘uncomfortable truth’ for scientists, but some adult primates have mental abilities greater than human infants3 so an EU-wide strategy to replace them with alternative techniques is a matter of moral as well as scientific urgency.

An Opinion by SCHER was requested by the European Commission as part of the long delayed revision of Directive 86/609/EEC, Europe’s animal experiments law. A proposal to revise the law was published on Nov 5 20084. The Commission has been under intense pressure to examine the ethical and scientific case for an EU phase-out of primate research and testing. In September 2007 the European Parliament overwhelmingly voted in support of a Written Declaration demanding an end to research on great apes and wild-caught primates and establishment of a timetable for replacing the use of all primates with ethical alternative research techniques5.

Emily McIvor, Policy Director at the Dr Hadwen Trust for Humane Research, says despite being asked to produce a scientifically balanced and accurate assessment, SCHER’s Opinion is flawed from the outset because it assumes the credibility of primate research without unbiased scientific scrutiny.

“SCHER’s Opinion could and should have been a turning point in Europe’s bioethics, mapping out what needs to be done to achieve primate-free laboratories.” says Ms McIvor, “Instead it lacks both the scientific scrutiny and the necessary vision to do anything other than maintain the status quo. Its blind acceptance of the validity of primate research in areas such as neurology, stroke and AIDS, despite clear evidence to the contrary, suggests a level of bias or inaccuracy that would simply be deemed unacceptable in other areas of scientific enquiry.”

The Dr Hadwen Trust is particularly disappointed by the Committee’s assessment of non-animal alternatives. Whilst SCHER does “recognises that there are promising developments that have replaced non-human primate use6“, its assessment of alternatives is short-sighted. Where current replacement gaps do exist and primate ‘models’ are clearly failing, SCHER could and should have called for urgent priority funding.

“Almost 10,500 primates are subjected to experiments in Europe every year, despite many of them having cognitive abilities comparable to human babies.” says Emily McIvor, “That may be an uncomfortable truth for some scientists, but that makes strategy to replace primates a matter of moral and scientific urgency. Advanced techniques like human brain imaging, computer modelling and human cell culture are already replacing primates with studies more relevant to human patients. With further technology development, total replacement is achievable but SCHER seems to have ignored that path to progress.”

Primate research: failed treatments and new hope

AIDS: Over 25 years, at least 37 animal-tested HIV vaccines have failed in human trials. Rhesus macaque monkeys are the favoured, but unsuccessful, ‘model’ but these could be replaced with a combined approach – population studies, in vitro cellular infection models including the newly launched ‘human immune system in a test tube’, molecular biology and computer modelling.

STROKE: Ninety-five stroke drugs have passed animal tests but failed in human clinical trials. For over 170 years primates have been used but failed to yield safe, effective new drugs for people. Population studies, brain imaging, post-mortem brain analysis and in vitro multi-cell cultures would provide more useful data relevant to human stroke.
MY COMMENT: BE CAREFUL IF YOU USE THIS ONE. VIVISECTORS SAY THAT THE REASON THE TREATMENTS WORKED IN MONKEYS BUT NOT HUMANS IS BECAUSE THE MONKEYS WERE IN THE LABORATORY AND WERE TREATED VERY QUICKLY. HUMANS WITH REAL STROKES WERE OFTEN TREATED HOURS AFTER HAVING THE STROKES. EVEN THOUGH THIS IS TRUE, THE MONKEYS DIDN'T HAVE STROKES. THEY HAD THE BLOOD SUPPLY TO THEIR BRAINS INTERRUPTED BY ARTIFICIAL MEANS. STROKE IS MUCH MORE COMPLEX THAN JUST SHUTTING OFF BLOOD TO THE BRAIN. IT USUALLY OCCURS AFTER YEARS OF NARROWING OF THE ARTERIES TO THE BRAIN, OR HIGH BLOOD PRESSURE, DIABETES, AND OTHER THINGS. THIS WILL BE ACCOMPANIED BY OTHER CHANGES IN THE BODY. HEALTHY MONKEYS WILL NATURALLY RESPOND TO TREATMENTS AFTER HAVING BLOOD SUPPLY INTERRUPTED FOR A FEW MINUTES. THE HUMAN STROKE VICTIMS WILL HAVE LIVED UNHEALTHY LIVES FOR MANY YEARS AND WILL NOT BE ABLE TO RECOVER SO EASILY. THE IGNORANT VIVISECTORS CAN'T GRASP THIS SIMPLE FACT. OR, THEY CAN BUT IGNORE IT BECAUSE IT IS INCONVENIENT.

MALARIA: 350-500 million cases of malaria occur worldwide, and over one million people die from malaria each year. Vaccines developed and tested in primates have failed in humans. In vitro human liver cell cultures could soon replace primates in identifying vaccine candidates and screening anti-malarial drugs.

BRAIN FUNCTION: Research into human psychological processes such as memory and depression can involve surgically implanting electrodes in, or removing parts of, the brains of primates. Advances in non-invasive imaging now provide a range of cutting edge imaging techniques, including the creation of temporary ‘virtual’ lesions in the human brain. With these more relevant techniques available, the use of primates is scientifically superseded as well as being ethically inappropriate.

HEPATITIS C: Despite decades of animal-based research there is still no definitive cure or vaccine. Mathematical modelling has already benefited hepatitis C patients by elucidating the virus’s dynamics and improving drug treatment. Human cell cultures for research and drug screening for this illness have also led to major developments in this area.

Notes

1 The need for non-human primates in biomedical research, production and testing of products and devices, ec.europa.eu/health/ph_risk/committees/04_scher/docs/sher_o_110.pdf

2 The Dr Hadwen Trust is the UK’s leading non-animal medical research charity funding exclusively non-animal techniques to replace animal experiments, benefiting people and animals. drhadwentrust.org scienceroom.org

3 Comparison of human infants and rhesus monkeys on Piaget’s AB task: evidence for dependence on dorsolateral prefrontal cortex. Experimental Brain Research 74 (1989)

4 Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Draft proposal eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0543:EN:NOT

5 Written Declaration 40/2007 “Urges the Commission, the Council of Ministers and the European Parliament to use the revision process of Directive 86/609/EC as an opportunity to: i. Make ending the use of apes and wild caught monkeys in scientific experiments an urgent priority; ii. Establish a timetable for replacing the use of all primates in scientific experiments with alternatives.”

6 The need for non-human primates in biomedical research, production and testing of products and devices, SCHER, 3.2, p21.
In the EU, 10,451 primates were used in 2005; the vast majority (7,000) were used for toxicology studies, 1,450 are used for basic medical research including brain research and 1,400 are used for pharmaceutical R&D. In the USA, 62,315 primates were used in 2006. In Japan, an estimated 2,802 primates were used in 2004. In Great Britain, 3,125 primates were used in 2007.

drhadwentrust.org scienceroom.org

[Fauxmage]

ANIMAL EXPERIMENTS COULD END IN A GENERATION

(The Times) -- The use of animal experiments could be replaced by research on "virtual human beings" and tests on banks of living cells within a generation, scientists say. Computer modeling and advances in cell biology will allow researchers to assess new drugs far more precisely and without the involvement of animals.

For example, one innovation is the development of "micro-lungs" -- lung cells extracted from transplant tissue, grown in a laboratory culture and then tested with drops of toxicants such as cosmetics to assess the response.

Scientists attending The Times Cheltenham Science Festival described how such tools had the potential to replace the use oflarge numbers of animals.

Kelly BeruBe, a cell biologist from Cardiff University, said that the advances were now moving very fast, and offered the
prospect of enough quantitative data to allow much greater use of such virtual tests in the next decade.

timesonline.co.uk/tol/news/uk/science/article6433170.ece[/URL]

[Gliondrach]

I get a 404 error when I click on the link.

[Fauxmage]

Oh weird. I have no trouble viewing it.

[Gliondrach]

Yes, there are many scoundrels in medical research. Quite apart from their cruel methods, they are quite often caught out lying and cheating. And their employers and paymasters in the drug companies have many times been found bribing researchers and government employees.

It's no wonder that over 100,000 Americans die every year from the adverse effects of medically prescribed drugs. And another 2 million suffer from serious adverse effects.

Not only is their research antiquated, ineffective and cruel, but some of them often lie about and falsify their research results.

How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data

Daniele Fanelli

INNOGEN and ISSTI-Institute for the Study of Science, Technology & Innovation, The University of Edinburgh, Edinburgh, United Kingdom

Abstract

The frequency with which scientists fabricate and falsify data, or commit other forms of scientific misconduct is a matter of controversy. Many surveys have asked scientists directly whether they have committed or know of a colleague who committed research misconduct, but their results appeared difficult to compare and synthesize. This is the first meta-analysis of these surveys.

To standardize outcomes, the number of respondents who recalled at least one incident of misconduct was calculated for each question, and the analysis was limited to behaviours that distort scientific knowledge: fabrication, falsification, “cooking” of data, etc… Survey questions on plagiarism and other forms of professional misconduct were excluded. The final sample consisted of 21 surveys that were included in the systematic review, and 18 in the meta-analysis.

A pooled weighted average of 1.97% (N = 7, 95%CI: 0.86–4.45) of scientists admitted to have fabricated, falsified or modified data or results at least once –a serious form of misconduct by any standard– and up to 33.7% admitted other questionable research practices. In surveys asking about the behaviour of colleagues, admission rates were 14.12% (N = 12, 95% CI: 9.91–19.72) for falsification, and up to 72% for other questionable research practices. Meta-regression showed that self reports surveys, surveys using the words “falsification” or “fabrication”, and mailed surveys yielded lower percentages of misconduct. When these factors were controlled for, misconduct was reported more frequently by medical/pharmacological researchers than others.

Considering that these surveys ask sensitive questions and have other limitations, it appears likely that this is a conservative estimate of the true prevalence of scientific misconduct.

Complete study at:
plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0005738

[Gliondrach]

Read the original article - it has many clickable links going to further info. Put the address at the bottom in a browser.

There is ample evidence that some medical researchers are in it for the money or personal glory or some maniacal interest in finding answers regardless of who suffers in the process. Many vivisectors will argue that they love all animals but that it is necessary for human health to experiment on non-humans . This of course is wrong but that's the sort of nonsense they spew out. If they really cared about other animals they wouldn't eat them. They know that it is not necessary to eat meat or drink milk. They can't argue that eating meat is necessary for humans. They eat meat because they want to, not because they have to. Their argument about the necessity of using rats, dogs, monkeys and other non-humans in medical experiments is just as unfounded as any reason they can come up with for eating meat. If they eat meat when they don't have to but they say they care about the suffering of other animals, how can anyone believe them when they say they need to experiment on other species? They could just be trying to justify it as they would try to justify eating meat.

Many medical researchers have always been willing to experiment on humans. This has been going on for well over a century. It happened at Tuskugee, it happened in Nazi concentration camps, in Japanese occupied territories during the Second World War, with US servicemen who took part in CIA experiments, with UK National Servicemen who were poisoned with nerve gas, and in many other places and times.

The mind of the vivisector will always find justification for torturing others, including humans, in pursuit of whatever their goal happens to be.

And the members of regulatory bodies cannot be trusted to regulate. There's too much money and too much pressure to let something like ethics get in the way.

In universities any vivisection experiment must be reviewed and approved by their Institutional Animal Care and Use Committee. These are supposed to ensure that no 'unnecessary' experiments are carried out or that nothing too cruel is done. Many of these committees have been caught out when investigated and have been proved to be failing in their duties to protect the lab animals.

There is no protection for lab animals. There is no protection for humans. But there are huge profits for the drug companies and lots of cash for the people in governments and regulatory bodies who are in their pockets.



Ethics for Sale

For-profit ethical review, coming to a clinical trial near you.

By Carl Elliott and Trudo Lemmens
Posted Tuesday, Dec. 13, 2005, at 1:01 PM ET

If you missed the movie The Constant Gardener and need your fix of moral outrage, you don't have to go to Africa to find it. Just look instead at the December cover story in Bloomberg Markets about America's largest clinical testing center. Managed by a company called SFBC International, according to Bloomberg, the 675-bed Miami testing center has been recruiting undocumented Latino immigrants desperate for money, housing them in a converted Holiday Inn, and paying them to take untested drugs in studies overseen by an unlicensed medical director whose degree comes from an offshore medical school in the Caribbean.

So far, the plot is depressingly familiar. Drug companies spend $14 billion a year testing new drugs. The products need to be tested for safety on healthy people, and the healthy people most willing to ingest them are usually those with plenty of time and little money. Nearly 10 years ago, the Wall Street Journal reported that Eli Lilly and Company was recruiting homeless alcoholics to take part in drug trials in Indianapolis. In 2003, a previously healthy college student named Traci Johnson committed suicide in Lilly labs after being paid to take a new version of an antidepressant. Now Bloomberg is reporting that three years ago, Garry Polsgrove, a homeless Vietnam veteran, checked into the Fabre Research Clinic, a for-profit testing center in Houston. Polsgrove was in good health when he entered the study and started taking clozapine, an antipsychotic drug, in order to get some cash and a place to sleep. Twenty-two days later he was dead of myocarditis.

The new wrinkle in the Bloomberg story is that many of the questionable practices it reports unfolded under the nose of the for-profit organizations that researchers increasingly hire to conduct ethics reviews. In the United States, the primary means of protecting research subjects are ethics committees known as institutional review boards. IRBs originated in the 1970s in the wake of various medical research scandals like the Tuskegee Syphilis Study that left black men untreated for syphilis between 1932 and 1972, and a notorious study at the Willowbrook State School for the Retarded in New York, in which researchers intentionally infected mentally disabled children with hepatitis A. The idea was that to protect the welfare of research subjects, all studies would be reviewed in advance by an ethics committee independent of the researchers conducting the study, whose scientific zeal might lead them to shortchange safety. Traditionally, IRBs have been volunteer committees made up of scientists and clinicians working in the hospitals and medical schools where the studies they review are being carried out.

Today, however, the ethics review of more than half of all new drug submissions to the Food and Drug Administration is handled by a single for-profit IRB, Western Institutional Review Board in Olympia, Wash. (according to Western's owner, Angela Bowen, as quoted in Bloomberg). At the SFBC clinic in Miami, some of the ethics review was done by a for-profit IRB owned by the wife of an SFBC vice president. At the Fabre Research Clinic in Houston where Garry Polsgrove died, the ethics review was conducted by a for-profit IRB run by Louis Fabre, the clinic owner. (The Fabre clinic and its IRB have since shut down.) If you find yourself down on your luck and are tempted to volunteer for an industry-sponsored drug study, chances are that you will be entrusting your safety to a private board that is operating with very limited government oversight, and that is being paid by the drug company whose drugs you are taking.

How did we get here? When IRBs were established a generation ago, medical research was conducted mainly by individual investigators working in medical schools who were funded by the federal government and who had little financial stake in their studies. These days, medical research is a massive, multinational corporate enterprise. Rather than contracting with academic researchers to test new drugs, the pharmaceutical industry has found it cheaper and more efficient to conduct studies in physicians' offices, industry laboratories, and private testing sites like SFBC's in Miami. As recently as 1994, 63 percent of clinical trials were taking place in academic settings. Ten years later, that figure had shrunk to 26 percent. Along with private-sector clinical research has come private IRBs, which market themselves by promising fast and industry-friendly service.

The demand for private IRBs isn't hard to understand. In today's research environment, academic IRBs often are overmatched. They're often slow and inefficient, and they are staffed by volunteers who would usually rather be somewhere else. Nor are academic IRBs free from conflicts of interest. Their members are frequently asked to review studies being conducted by their friends and colleagues. And a recent survey of academic IRB members found that nearly half had served as consultants to the drug industry.

But the private IRBs have a direct financial interest in keeping their drug-company clients happy. If one for-profit IRB rejects a study as unethical, the pharmaceutical company sponsoring the study can simply send it somewhere else. Free-marketeers argue that there's a countervailing pressure that should make drug companies welcome strict policing from the IRBs—the possibility that a strict ethics review on the front end could head off a lawsuit on the back end. But in reality, the incentives don't pan out that way. Lawsuits, while on the rise, are still relatively rare. For the companies bankrolling the clinical trials, litigation is a quite-manageable cost of doing business.

Surprisingly, for-profit IRBs have drawn little criticism from bioethicists. Instead, some university and government scientists are increasing their influence. A few universities, such as Johns Hopkins, have begun using for-profit IRBs to review their research. Ezekiel Emanuel, the chief of bioethics at the National Institutes of Health, spoke enthusiastically about for-profit IRBs in general and Western IRB in particular during a presentation about research review that he made to the President's Council on Bioethics a few years ago. "I think there are a lot of reasons that make Western and a few of the others very good," Emanuel said. "One is certainly leadership and dedication to doing the right thing, and believing that by doing the right thing, you'll be successful, and in their case profitable." Yet according to Bloomberg's December cover story, Western IRB gave ethical approval to studies in Los Angeles and Georgia that later turned out to be fraudulent. The researchers involved reportedly wound up in prison for lying to the FDA and putting the lives of subjects in danger. Western IRB has also been sued for approving a placebo-controlled study of a Genentech drug called Raptiva. In that study, Bill Hamlet, a patient in North Carolina ill with psoriatic arthritis, claims that he was taken off his regular medications, which had been effective, and given a placebo instead. When Hamlet withdrew from the study six months later, he says his body was covered with bleeding scabs and he was bedridden from his psoriatic arthritis. The lawsuit was settled out of court.

IRBs were never intended to be formal regulatory bodies. They were supposed to provide a kind of professional self-regulation, in which scientists were advised by their colleagues. "I will begin by noting that IRBs are not policing bodies, watchdogs, or auditing agents," Robert Levine of Yale University, the former editor of the journal IRB, said when he testified before Congress in 1998. "IRBs were established to work collaboratively with investigators." That mission might have made sense 30 years ago. Today, however, the prevalence of private-sector drug research and the push to commercialize every facet of medical research makes the original model hopelessly outdated. Research subjects need a watchdog to protect them, and not one that is owned by the pharmaceutical industry. If IRBs cannot do the job, then we need to replace them with something that can.
slate.com/id/2132187/[/url]

[Gliondrach]

I've just read post 14 of this thread again. Points 4, 5 and 6 really are very good. The whole thing is but they are gooder. I'd like to know who that very sensible person is. He or she i just called an Oxford philosophy tutor.

You should all read it. I'll be asking questions about it later.

http://www.thesaucyvegan.com/showthread.php?t=1449

[gabbles]

The Process of Medical Discovery

By Brandon Reines, D.M.V.

Before we can talk cogently about animal experimentation and what it's good for and not good for, we need some historical perspective on the primary function of animal experimentation. Animal experimentation has many different functions. Historically, its primary function has been as a means for a clinician to sell or dramatize hypotheses or ideas to colleagues. Because the experimental laboratory is so flexible, and because there are so many different strains in species of animals, it is almost always possible to come up with a result that will buttress a preconceived conviction. One example is the case of cigarette smoking and cancer.

As I looked at all the different areas of medical research — the history of physiology, therapeutics, and pathology — my ten years of historical research showed that discovery in medicine basically follows three simple steps — clinical hypothesis, lab "dramatization," and clinical testing.

Generally a doctor or a surgeon — someone who looks directly at human patients — identifies a series of anomalous cases, i.e., cases that do not quite fit the preconceived picture. Now, in the case of cigarette smoking and cancer, in the early part of the century, surgeons and clinicians started to notice that people who smoked cigarettes developed a very rare form of lung cancer. So this initially anomalous result was seen in human patients and on that basis, clinicians hypothesized that cigarette smoking may cause cancer. The next step was to proceed to epidemiological studies — large scale studies of human populations. This was done in both Britain and the U.S. Data was collected from many thousands of patients who smoked cigarettes, and it was found that, statistically, cigarette smoking does, indeed, cause human lung cancer.

The epidemiologist Ernst Winder could not convince his physician colleagues in the U.S. that cigarette smoking causes lung cancer in human beings, so Ernst Winder painted the skin of mice and rats with cigarette tars. He did this because he knew that doing it by inhalation, i.e., blowing smoke down the mouse's trachea, would never produce tumors. Inhalation was attempted in mice, rats, guinea pigs, rabbits and many other laboratory animal species, and it simply could not induce lung tumors.

Poor Ernst Winder kept painting the skin of different strains of rats and mice to try to induce a skin tumor, because he was unable to do it by inhalation. He finally found a strain of mouse in which he could induce tumors by skin painting, and then, in the late 1950's, he went on television and was able to convince some of his colleagues that cigarette smoking causes cancer. But again, the actual evidence came from studies of human beings.

Philosophers of science are now recognizing Aristotelian experimentation, the kind of experimentation in which you try to prove a point, or try to dramatize or sell a discovery that has already been made in a completely different context. Many of the great figures in the history of science were practitioners of Aristotelian experimentation.

One of the most renowned examples of an Aristotelian experimenter is Galileo. You've all heard the famous story in which Galileo dropped two cannon balls from the leaning tower of Pisa to see the rate of fall, in order to prove his theory of the fall of bodies and to attempt to disprove the old Aristotelian notions. Philosophers of science have shown that Galileo never actually performed the experiment. He developed his theory by thought experiment. Philosophers of science are now showing that many experiments — I think most of the animal experiments in the history of biomedical research — have actually been performed to dramatize discoveries already made by doctors, surgeons, clinicians, epidemiologists and others who study human patients directly.

The father of modern medical science is a 17th century Englishman named William Harvey, who is the patron saint of thousands of researchers all over the world and has been for 300 years. The method that William Harvey used to discover that blood circulates around the body has been a subject of great debate and contention over the past 300 years.

Most people today think that William Harvey discovered that blood circulates through vivisection — by experimenting on about 80 species of animals. This view was doubted by an historian named Sigismund Peller, who wrote a scathing critique of the view that animal experimentation led to William Harvey's discovery, in the 1949 issue of Bulletin For the History of Medicine.

Historians have since shown that Harvey actually discovered the circulation of blood in two stages. In the first stage, he discovered the mechanism of the pulse. He found that the heart contracts like a pump and blows blood into passive arteries. In that first stage of Harvey's discovery, as I've elucidated in my paper called "On the Role of Clinical Anomaly in Harvey's Discovery of the Mechanism of the Pulse" (published Fall 1990 in the American medical journal Perspectives in Biology and Medicine), William Harvey did not use animals to discover how the heart and blood vessels work. He studied a single anomalous case of a nobleman whose descending aorta had been calcified into a bony tube, and he found that beyond the region of the calcification, the patient, during life, had had perfectly normal pulses in the legs.

This contradicted a 2,000 year old animal experiment performed by the ancient authority Galen. It absolutely contradicted what Galen had shown. The animal experiment had been wrong. In fact, it is not possible to do the experiment Galen had outlined, because it would require opening an animal and inserting a hollow reed into its artery. There would be so much hemorrhage that, without anesthesia and other supportive techniques, the experiment could not possibly have been performed effectively. But there was a "natural experiment" in which the aorta of a nobleman had been hardened into a bony tube, and that showed clearly and conclusively that the heart works like a pump and blows blood into passively expanding arteries.

The next stage of Harvey's discovery was performed by a thought experiment very similar to the method that Galileo, Einstein, and all the greats used. Einstein called it "Gedanken" and it is precisely what Harvey did to elucidate the circulation of the blood — a very dynamic picture and not something you could possibly have elucidated in animal experiments because in animal experiments you just get time shots, or snapshots in time.

What Harvey did accomplish with animals was to convince his colleagues that his theory was correct. Even at that time, during the Renaissance, because of the influence of René Descartes and Sir Frances Bacon, Harvey had to perform animal experiments to convince his colleagues that the blood circulates. He used a dead deer to convince King Charles the First of his theory. There is absolutely nothing in a dead deer that will prove that blood circulates, but it's something you can hold up in front of someone like the King and explain in very simple terms. It's a teaching tool, a way of educating students, but it has absolutely nothing to do with the process of discovery.

Harvey used simple clinical methods to verify his hypothesis, already worked out by thought experiment and by studying the nobleman. One such experiment, performed very late in the process, showed that blood would fill up on the side closest to the body when a ligature was placed on the arm .

One feature of the animal experimental method is its drama — it is so much more dramatic than clinical discoveries that animal researchers get credit for virtually every discovery ever made in the history of medicine. A clinician will make the discovery, then an animal researcher will perform a dramatic, showy, sometimes bloody experiment and will plagiarize credit for the discovery which had already been made.

A very famous experimental surgeon named Alexis Carrel won the Nobel Prize in 1912, ostensibly for discovering organ transplantation and techniques of blood vessel repair. It is quite clear historically that Carrel was actually dramatizing discoveries already made by leading figures in abdominal surgery in the latter part of the 19th century. Even his technique of connecting the two severed ends of the blood vessel, which underlies modern organ transplantation, was plagiarized from the clinical surgeon Robert Tuttle Morris.

Carrel also received credit for performing the first bypass surgery using segments of the patient's own vein to bypass obstructed arteries. He is credited with all the modern breakthroughs in vascular surgery. In actuality, vascular and bypass surgery began to evolve in the 1700's under the influence of William Hunter, a very famous British anatomist. Hunter found that in certain anomalous human cases, there is a shunting of blood from the artery into the vein. This situation can occur from injury, or, as in former times, when a patient was purposely bled, and an artificial connection between artery and vein was created.

William Hunter was able to demonstrate that the person's own veins can withstand this very high blood pressure normally found in the arterial system. This finding is actually the bedrock of the bypass principle, because all modern leg and coronary artery bypasses rely on segments of the patient's own vein to bypass arteries obstructed by atherosclerotic plaques.

Dr. Jean Kunlin is the surgeon who, in the late 1040's, actually discovered modern bypass surgery. His work relied on the earlier discoveries of William Hunter and others who had shown that in human beings, the vein could withstand very, very high blood pressures, and, therefore, could be used for bypass.

To demonstrate how disastrously far off track animal experimentation can throw the entire community of medicine, in 1952 some researchers performed animal experiments using vein as bypass material to determine whether segments of the animal's own vein would withstand the very high blood pressure in the arterial system. This experiment was presented in 1952 at the annual conference of the American College of Surgeons.

The researchers concluded, on the basis of their animal experiments, that it was not possible to accomplish bypass grafting with segments of the patient's own vein. Instead, the patient's artery should be used. This is because in dog experiments, when the segment of vein was inserted into the arterial tree, it ballooned out into an aneurism. The researchers were, therefore, afraid that if they placed these segments of vein into patients' arterial trees in the leg or coronary arteries, they would kill people because the vein segment simply would not hold up.

Because of these misleading animal experiments, most surgeons declined to use patients' own veins to bypass obstructed arteries for about ten years, at least until the early 1960's. Finally, a few surgeons began to believe the clinical data — 200 years of evidence showing that very high blood pressure did not burst veins in human beings. This evidence came from cases of arterio-venous aneurism, in which veins were used to bridge obstructions in arteries during war surgery and in other clinical contexts. It was shown very clearly that vein bypass would work. Clearly, misleading animal experiments retarded the development of modern bypass surgery by about 10 years.

Dr. Robert Tuttle Morris is the real pioneer of modern organ transplantation. He was already performing ovarian transplants between women by the 1890's. He discovered the endocrine function of the ovary, the theory that the ovary secretes hormones, a revolutionary theory in his time, but he never received credit for any of his theories. He also pioneered vascular surgery and developed the technique for connecting the severed ends of blood vessels. Indeed, he made so many discoveries that today, he would be awarded three or four Nobel Prizes. But he is given credit for virtually none of his discoveries. The credit went to animal researchers.

To demonstrate once again that bench scientists, or animal researchers, have much more prestige around the world than clinical researchers, I suggest the case of Sir Peter Medawar, who won the Nobel Prize in 1960 for his theory of acquired immunological tolerance. This is one of the theories that underlies modern organ transplantation. In 1950, Sir Peter Medawar and the other animal researchers said that if organ transplantation were attempted in human beings, they would be doomed to death. They based this conclusion on the results of rabbit and dog experiments. The rejection response of these animals was so violent that they thought surgeons would be signing their patients' death warrants were they to attempt even kidney transplants.

Nonetheless, groups in Boston and France performed kidney transplants in human beings. They found that in patients with severe kidney failure, there exists a state of natural immunosuppression such that the toxins that build up in the body actually suppress the immune response. Therefore, a rapid and violent rejection of the transplanted organ as seen in normal, healthy laboratory dogs was not found. Again, this shows that animal experimentation can be quite misleading.

The clinical investigator who actually discovered acquired immunological tolerance, a theory attributed to Sir Peter Medawar, was a little known American country biologist named Ray David Owen. He did not study a human patient, but rather an "experiment of nature" — an animal whose condition constituted a natural experiment, similar to what Harvey did when he studied the nobleman with the calcified aorta.

This is probably the most extraordinary natural experiment in the annals of biology. It is called the Freemartin co-twins. Under certain conditions, cattle twins are connected in utero by a system of blood vessels, creating a free flow of stem cells, which are the bone marrow cells that are the precursors of all the blood cells that form in the body (Figure 6). During uterine life, there is a constant flux of stem cells from one fetus to the other.

On the basis of this natural experiment, Owen showed quite clearly that the adult cattle twins actually had each other's blood types. They had their own blood type plus the blood type of the co-twin. And, they had become tolerant to the co-twin's blood type, which is absolutely unheard of in the annals of immunology prior to Owen's time. This momentous anomaly spurred the growth of "The New Immunology," as it is now called.

Most of the really important breakthroughs in immunology grew out of Owen's study. It also opened the door to modern organ transplantation, because researchers felt that if nature could do it, then humans could do it. They believed that there must be some way to render an individual tolerant to donor tissue.

We must return to the 1890's to demonstrate how far back this issue of plagiarism between animal researchers and clinical investigators goes. The most famous animal researcher in the 1890's in England was Sir Edward Sharpey-Schaefer. Sharpey-Schaefer has been credited with discovering how the adrenal gland — the little gland that sits on top of the kidney — works. He was also given credit for discovering adrenalin and for being the father of modern endocrinology. In fact, Sharpey-Schaefer had nothing to do with founding modern endocrinology. He plagiarized a little known country doctor who was studying human patients, a clinical investigator named George Oliver.

George Oliver studied patients who had tuberculous infiltration of their adrenal glands, and deduced that this condition causes Addison's disease, which results in very low blood pressure. He connected destruction of the adrenal glands with very low blood pressure in human beings, and concluded that there must be a hormone in the adrenal gland that maintains blood pressure and vitalizes the heart. He did not name the substance adrenalin, but he had already discovered and extracted it from the adrenal gland of oxen.

Oliver knew that his clinician colleagues and others would not believe that he had discovered something of value, even though he had already tried the extract on his son and showed that it would raise blood pressure. To convince his colleagues, he asked the famous animal researcher, Sir Sharpey-Schaefer to try this extract on cats. He felt certain it would have a dramatic effect on blood pressure and on vitalizing the heart. Sharpey-Schaefer granted Oliver's request and showed that the extract would raise blood pressure in cats. Because he went to Sharpey-Schaefer, however, he lost any claim to credit for the discovery. Oliver is now totally unknown, despite the fact that the discovery was made in the context of his clinical practice.

One of the most dramatic stories in the history of medicine is the discovery of the polio vaccine. The discovery and development of an effective polio vaccine has been attributed to animal experimentation alone. In fact, it's a very mixed story.

Dr. Simon Flexner was the head of the Rockefeller Institute for Medical Research in New York City from about 1911 to 1930. Flexner had been doing monkey experiments with the polio virus for about 20 years. He was blowing the polio virus into the nose of monkeys in an attempt to model how polio grows and spreads in the human body — an understanding absolutely essential to develop an effective vaccine. However, the model that he developed in monkeys is now known to be totally wrong, and Flexner completely mislead the entire field of polio research for about 20 or 30 years.

What he supposedly showed in his monkey experiments was that the polio virus will only grow in the nervous system. That finding retarded the development of a vaccine because it is not desirable to grow a vaccine in a tissue culture made from nervous tissue, since nervous tissue is extremely allergenic. If killed virus grown in nervous tissue were injected into patients, they would have all kinds of horrendous brain reactions. It had to be grown in tissue from outside the nervous system.

The real hero of the polio story was a Swiss epidemiologist named Ivan Wickman, who showed that polio is primarily an intestinal disease and rarely a disease of the spinal cord. John Enders won the Nobel Prize in 1949 for developing a tissue culture method of growing polio virus, which allowed him to mass produce the polio vaccine. Enders revealed in his Nobel lecture that the fact that children with polio were excreting the virus in their feces led him to hypothesize that polio virus could be grown in intestinal tissue, not in nervous tissue. On the basis of this observation in human beings, Dr. Enders began to grow the polio virus in a tissue made from human intestinal tissue. This allowed him to mass-produce the polio vaccine and led to the breakthrough.

The story of the discovery of the Rhesus factor is another example of the kind of plagiarism I have been talking about. The actual discoverer of the Rhesus factor is Dr. Phillip Levine. Dr. Levine was studying a patient in a New York hospital named Mary Seno, who had had a severe transfusion reaction both to her husband's blood and to that of her unborn fetus. The fetus was born dead.

Based on the patient's severe transfusion reaction, Levine deduced that there had to be some factor on the surfaces of red blood cells which had not been classified yet by the ABO system of blood typing. He should have named it the Levine Factor. If he had, there wouldn't have been all this confusion. People would not have thought that the Rhesus Factor was discovered in Rhesus monkeys. But since he didn't name it, he was plagiarized by Alexander Weiner, the supposed discoverer of the Rhesus factor.

Alexander Weiner performed a very dramatic monkey experiment, ostensibly demonstrating the same factor that Levine had shown existed on the surface of Mary Seno's red blood cells. In fact, Philip Levine later showed that Alexander Weiner's results were erroneous.

In summary, the historical role of animal experimentation has not been primarily scientific. In certain contexts, animal research has been of value, historically, even in the case of the polio vaccine. At that time, using monkeys was the only method available to grow the polio virus. In those days, they didn't know how to grow the polio virus in a test tube, and if they wanted to determine whether or not there was polio virus in the feces of a child, the only means they had of detecting it was to inject it into the brains of monkeys. Of course, this is now outdated.

Historically, once again, the primary role of animal experimentation has been to sell or dramatize discoveries that were already achieved by surgeons, clinicians, and others in the actual clinical context of work with human patients.


Questions

Question: You mentioned that experiments on animals actually harmed human health, because they resulted in suppression of valuable discoveries for many years, while vivisectors "dramatized" the discoveries through animal experiments. In your research, have you found any historical connection between this suppression and economic interests that were benefited by, and therefore had an incentive to encourage and support, this suppression?

Answer: Yes. From the standpoint of people with a vested interest, that's the beauty of animal test results. There are so many different animal strains and species that you can get virtually any result you want.

The case of cigarette smoking and cancer is a beautiful example. The tobacco industry hired one of the best known animal researchers of the 1950's, Clarence Cook Little, to perform their tests of tobacco on mice to determine whether or not tobacco caused cancer. Clarence Cook Little is the founder of the Bar Harbor Jackson Laboratories in Bar Harbor, Maine, one of the two major mouse breeding laboratories in the U.S. It's one of the major suppliers of in-bred mice for researchers around the world and one of the most prestigious research institutes in the U.S. So Clarence Cook Little had tremendous prestige in the 1950's.

The tobacco industry knew that Little was someone who would give them what they wanted to hear. So Little performed these inhalation experiments in mice, and he showed that if you force mice or any other animal to smoke cigarettes, they don't get lung tumors. So Clarence Cook Little debated epidemiologists and biostatisticians such as Winder and Irwin Bross. Little was like a hit man for the tobacco industry.

An epidemiologist from the American Cancer Society would say: "On the basis of a study of one million human beings in the United States, we have conclusive evidence that cigarette smoking causes cancer in human beings." And then Clarence Cook Little would say: "On the basis of a study of 1,000 mice, we have conclusive evidence that cigarette smoking does not cause cancer in human beings." Of course, he was really using a kind of Orwellian "New-speak" by saying that something that is valid for mice is valid for human beings. What he meant was that cigarette smoking does not cause cancer in mice. But by adopting this Orwellian "New-speak," that I call "Lab speak," he was able to say that on the basis of mouse experiments, cigarette smoking does not cause cancer in humans. So, yes, vested interests have long benefited from this inherent flexibility of animal test data.

Question: Why do you think that clinical discoveries and discoverers are so minimized in the history of medicine?

Answer: There are many, many reasons. I think, probably, the simplest reason is that human beings, by their nature, tend to create icons. They tend to create very simple pictures or symbols to represent what they know about the world around them. If you ask anybody how they know current events, they say: "From watching TV." So, human beings tend to learn by looking at very dramatic images. Now, the image of a vivisected animal is a very dramatic image. It's like watching TV, or like watching a movie. It's something that's very visual and evocative and it gives you a gut feeling right off.

However, talking about a thought experiment or a surgeon studying an experiment of nature is different. I noticed that when I was talking about experiments of nature or statistics, or studying patients, some of you started to kind of nod off or become less interested, because it's simply not as interesting to hear about as a blood and guts animal experiment, or a cat with electrodes in its head. And I think that, fundamentally, it has to do with human psychology. The way human beings learn is by these very dramatic visual images. And science is not particularly dramatic or visual. It's actually a linguistic process. Theories are something that are written down, in language, numbers, or equations. They are quite humble and they can't be held up or patented, for that matter. So I think it's fundamentally a question of human psychology.

Question: Some people say that not everything you find out in science is purposeful. Sometimes you just find something by mistake. Scientists might argue that in studying animals, we might find out something about humans. Even if it is not 100% true, it should be done anyway. They also say that humans are more important than animals. What would you tell them?

Answer: Your question has two parts and I'll try to answer both of them. Your first point involves this idea of luck or chance, that you really just have to do a zillion experiments so that serendipitously you'll make some sort of discovery. You've hit upon the central argument of the father of experimental medicine, Claude Bernard, the French physiologist. In Bernard's An Introduction to the Study of Experimental Medicine, he claims that all of his discoveries were made by accident, in the laboratory setting.

I've just written a very esoteric paper that debunks that whole notion. Actually, Claude Bernard read autopsy reports. For instance, while he was "discovering" that pancreatic juice digests fat, he read a paper written 20 years before he began any of his laboratory experiments. He read several papers on autopsy reports of patients who had pancreatic ducts obstructed by carcinoma and who also had very fatty feces, and on that basis, he deduced that the pancreatic juice must split fat.

Instead of reporting the actual sequence of events in his book An Introduction to the Study of Experimental Medicine, Claude Bernard said "I discovered that pancreatic juice splits fat by accident, in rabbit experiments." Saying that the discovery was by accident severs the laboratory from the clinic. It's a way of saying: "I didn't get any inspiration from the clinic, from other doctors, from anything I ever read. It came solely from that dramatic event in the laboratory setting, solely by that accident in the laboratory, full-blown like a picture."

Since that time, most of the books about biomedical discoveries present them as simply a succession of laboratory accidents. Pasteur's rediscovery of vaccination supposedly happened because he accidentally left some flasks out on his laboratory table containing some cholera organisms that became naturally attenuated. When he returned from vacation, he injected them into some chickens and, lo and behold, the chickens didn't die and were vaccinated against subsequent injections.

In fact, Pasteur was building on Jenner's prior work in the 1700's in human beings. Jenner is the actual father of vaccination. He showed that you could vaccinate against one disease by using an attenuated form of another disease.

So invoking laboratory accident is simply a way for the animal researcher to divorce his discovery from its actual moorings and origin in the clinic. And I've demonstrated this time after time. It will be documented in my upcoming book. It's simply a ruse, a way of plagiarizing a discovery that has already been made.

Your second point was that humans come first. I agree totally that humans come first and that public health comes first. But, when I started looking into this whole issue about 10 years ago, being a very curious and thoughtful person, I didn't want to take a stand on any issue until I really understood the ins and outs of it. So being someone who does care for human beings first and foremost, I really wanted to have the issue down before I started making any kind of public statements or analyses.

What I found, again, is that, historically, animal research really served a very small productive function. Primarily, animal research was useful in the early days of infectious disease research, when they needed some system in which to grow bacteria, viruses, or parasites. They didn't have tissue cultures, so they absolutely needed the animals in those days.

Today, when most diseases are non-infectious — cancer, heart disease, stroke, mental illness — when most diseases are really a breakdown of the patient's own body and tissues, you simply can't extrapolate from animals. You don't have that simple analogy of a living test tube — an animal infected with a germ is like a test tube infected with a germ is like a human with an infectious disease.

In the non-infectious diseases, the analogy breaks down. You simply cannot extrapolate from a mouse tumor to a rat tumor or from a rat tumor to a human tumor. So on purely public health grounds, the National Cancer Institute has now switched from using mice to search for cures for cancer to growing the patient's own tumors in the test tube. And that's how the National Cancer Institute is now screening for potential drugs for the treatment of cancer, by testing on these human tumors grown in the test tube. It's an attempt to overcome the extrapolation problem which the U.S. Federal Research Bureaucracy is finally facing.

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

References

1. Reines, B. P.: On the role of clinical anomaly in Harvey's discovery of the mechanism of the pulse. Perspectives in Biology and Medicine 34(1):128–133, 1990.

2. Reines, B. P.: On the locus of medical discovery. The Journal of Medicine and Philosophy 16:183–209, 1991.

3. Reines, B. P.: Masked Men of Medicine. Unpublished Manuscript.

[Gliondrach]

Yes, the truth needs to be told about these things.

[Gliondrach]

As Public Support for Vivisection Wains, Alliance for Progressive Science Counters Animal Abusers’ Attempt at Resurgence

November 20, 2009 — Negotiation Is Over
Simulposted with the NAALPO

Dr. Steven Best, Philosopher
Dr. Jerry Vlasak, NAALPO Press Officer
Jason Miller, Thomas Paine’s Corner, NAALPO Press Officer
Camille Marino, Negotiation Is Over

In January 2006, 16-year-old Laurie Pycroft formed the “Pro-Test” movement in the UK to rally public support for vivisection in the face of vocal animal rights opposition. The group’s young spokesperson, Tom Holder, came to the US in 2008, funded by a vivisection industry front group, to start Speaking of Research, a “media” network that promotes animal “research.” In March 2009, Dr. David Jentsch founded a Pro-Test chapter at UCLA and, with Holder’s support, a new movement of aggressive vivisector- activists was born.

Deploring the research community’s inadequate response to aggressive anti-vivisection campaigns, Pro-Test activists advocate fearless defense of their agenda and have initiated a new offensive in the ongoing science wars. In alliance with the Americans for Medical Progress, a vivisection industry front group, and with the aid of a million dollar bankroll, Pro-Test forces have rallied their base, organized spirited protests, spread their message through newspapers ad and billboards, and promoted disinformation generally.

While the Pro-Test movement is still small, it must not be underestimated. In the 1980s the animal rights movement thought it had shut down the fur industry, only to witness its vigorous resurgence a decade later; anti-vivisectionists must not make the same mistake and need to attack every new tactic and campaign, every novel threat. In October 2009, amidst a glaring neglect of critical attention two leading total liberation blogs, Thomas Paine’s Corner (TPC) and Negotiation Is Over (NIO), joined forces with Dr. Steven Best and the North American Animal Liberation Press Office (NAALPO) to create the Alliance for Progressive Science (APS).

APS was formed to attack Pro-Test on both scientific and ethical grounds. APS exposes the powerful economic interests driving the vivisection complex and 17th century research paradigms, during a 21st century era of advanced nutritional science and hundreds of sophisticated technological alternatives to nonhuman animal research and testing. Through the concept of “progress,” APS emphasizes both the moral bankruptcy of vivisection and its antiquated and unscientific nature, combating the stereotype of animal rights as “anti-scientific” and “anti-progress.”

APS champions a new research paradigm that is “progressive” in its embrace of animal rights and development of new technologies that promise qualitative leaps in science and medicine. APS emphasizes that the vivisection industry, not the animal rights community, is the true terrorist menace and the real obstacle to moral and technological progress, in that it clings tortures and kills up to 100 million nonhuman animals a year, it operates with fallacious research models, it prostitutes science and the public interest to profit and the capitalist interests of pharmaceutical corporations.

To maintain critical focus on the new propaganda tactics of the vivisection industry, NIO is establishing a network of bloggers committed to publishing regular articles on the Pro-Test propaganda front to advance a new model of science, medicine, and progress. We urge fellow activists to join us; to become regular readers of NIO and TPC; to follow our reporting on Pro-Test tactics and campaigns; to research, write, and publish on our pages your own essays; and to advance a new concept and practice of science and medicine that relegates vivisection to its rightful place – in the dustbin of history.

APS does not compete with, but rather compliments, existing anti-vivisection activism. APS seeks to put down the new tactical fronts and propaganda efforts designed to erase two centuries of anti-vivisection activism and to expand the vivisection industry and Big Pharma to unprecedented levels of killing, influence, and profit. Please review our upcoming website and more detailed statement of purpose in our critical manifesto for a progressive science. We look forward to your thoughts and hope we can work together to stop Pro-Test, abolish vivisection, and take the giant strides in science and medicine that the vivisection industry, universities, pharmaceutical corporations, and government so effectively blocks.

negotiationisover.com/?p=3887

[Gliondrach]

I hadn't heard of the Nurses' Movement for Responsible Medicine before today. I think they might be linked with the PCRM.

The objective of NMRM is the
IMMEDIATE AND UNCONDITIONAL ABOLITION
OF ALL ANIMAL EXPERIMENTS
ON
MEDICAL AND SCIENTIFIC GROUNDS

NMRM opposes animal experimentation on medical and scientific grounds. We are well aware that animals do not react in the same way to drugs and other substances as we do, due to differences in their absorption, distribution, metabolism, response to and elimination of drugs. But this is not something you are likely to hear from our country’s media, which has consistently shown itself to be pro-vivisection due the very many vested interests. Animal experimentation has resulted in immense human damage. This has affected people of all ages and continues to affect an unacceptably high percentage of patients.

www.nmrm.org