A new study in JAMA raises an interesting question about using animal models to predict drug response. Taking the diabetes drug rosiglitazone has been linked to an increased risk of heart attack. The study was a meta-analysis, which is a fancy way of saying scientists analysed all the studies that have been conducted on rosiglitazone and combined all the data in order to make a judgement about the drug. The conclusion that rosiglitazone increases risk for heart attack is controversial for reasons that do not have an impact on this blog, hence we will ignore them.
The question this study brings to the fore is:
What is the purpose of testing new drugs on animals? Specifically, are these tests to protect the patients taking them when the new drugs come to the market? Or, are the animal tests supposed to protect the volunteers and patients that take the drug in clinical trials?
The reality is, the animal tests fail in both cases. But the question is valid because the animal experimentation industry, via its spokespeople, tells society that animal testing is performed to keep children and other patients safe. They claim that every time a child takes a new drug, he would be at risk of death and severe side effects were it not for animal testing. On the other hand, when new drugs kill people or cause liver failure or other severe adverse reactions, the same people claim that the animal tests are performed merely to decrease the risk of those in clinical trials and that animal tests cannot predict what a drug will do to large numbers of genetically diverse people.
Like I said, animal tests fail on both accounts but I would really like to know which position the industry affirms. If they admit the tests are done in order to protect volunteers and patients in clinical trials then it is disingenuous to sell animal testing to society on the basis of protecting the general public after the drug goes to market. On the other hand, if they maintain animal testing is necessary in order to protect society after the drug goes to market, then they have to explain all the failures. Failures like:
Opren (Oraflex)
Bextra (valdecoxib)
Vioxx (Rofecoxib)
Mibefradil (Posicor)
Astemizole (Hismanal)
Baycol (Cerivastatin)
Raplon (Rapacuronium)
Phenylpropanolamine
Propulsid (Cisapride)
Rezulin (Troglitazone)
Bromfenac (Xibrom)
Seldane (Terfenadine)
Grepafloxacin (Raxar)
Etretinate (Tegison)
Levomethadyl (Orlaam)
Technetium (99mTc) fanolesomab (NeutroSpec)
Pemoline (Cylert)
Pergolide (Permax)
Tegaserod (Zelnorm)
Practolol
Suprofen
Fenclozic acid
Fenoterol
Dexfenfluramine
Zimeldine
The above is a partial list.
Allow me a moment to anticipate the usual response to this question. “Thousands of new drugs have been released and a vast majority are safe and effective for humans. This fact refutes your argument.”
Number 1, a vast majority of drugs have been approved for added uses or were me-too drugs, which are drugs that were very similar to others already in distribution. Many drugs were already known to be safe and were just reformulated to last longer, or they were approved for different uses that came to light after they had already been released in the market. According to the National Institute for Health Care Management, of the 1035 New Drug Applications between 1989 and 2000, only 155 were judged by the FDA to be new molecular entities (NMEs). This means a vast majority were variations on a theme or me-too drugs (1). These approvals are not new in the sense of animal models predicting their safety or efficacy.
Number 2, many drugs in use today were approved prior to animal testing. Included in this category are morphine, nitrous oxide, and digitalis.
Number 3, most drugs are not, in fact safe for everyone. Nor are they efficacious for everyone. Think of the numerous drug-recalls reported in the news because of previously unknown side effects. The animal models did not predict these side effects. Also consider the following. More than 500,000 outpatient children annually suffer adverse side effects from commonly prescribed medications. Children under the age of 5 are often the victims (2). Approximately the same numbers of children, already in the hospital, also suffer adverse effects. Approximately 700,000 outpatients must visit the emergency room each year due to adverse drug reactions (3). 15% of hospital admissions are caused by adverse drug reactions (ADRs). Legal drugs kill approximately 100,000/yr, more than all illegal drugs combined. This costs society over $136 billion in health care expenses. Most drugs are effective in 30–60% of patients. Adverse drug reactions are the fourth leading cause of death. 6.7% hospitalized patients suffer severe ADRs. (4)
Number 4, animals are not assessed to predict subjective reactions to drugs such as nausea, headaches, dizziness, and so forth—which also happen to be some of the most common side effects.
Number 5, just because a drug was tested on animals and did not harm humans does not mean that the test was predictive for this. In other words, just because the test correlated with the results from humans does not mean the test gives the right answers most of the time much less enough times to qualify as a predictive test. This particular correlation could have been a lucky guess or a random outcome. This in fact is what most animal human correlations are, as even when the outcomes are similar the mechanisms are not necessarily the same.
I would like an answer to my question so I could then challenge the nonsense based on the best science we have available instead of being forced to address two different answers simultaneously. By giving two different answers the animal experimentation industry can change the parameters when they are getting nailed on their nonsense. Then again, I would also like to live in a world where giant corporations do not take shortcuts that result in millions of gallons of oil spilling into the Gulf of Mexico.
References
1. Editorial, Modern Drug Discovery, 7 (2002).
2. F. T. Bourgeois, K. D. Mandl, C. Valim, M. W. Shannon, Pediatrics 124, e744 (Oct, 2009).
3. D. S. Budnitz et al., JAMA 296, 1858 (Oct 18, 2006).
4. J. Lazarou, B. H. Pomeranz, P. N. Corey, JAMA 279, 1200 (Apr 15, 1998).
Leave this carnival to the blind men cursed to it.
In time, carnivals and men become dust.
Animals are put into rape racks to be bred or into stereotactic mounts for tests because animal welfare organizations and experts beg for superficial “better” treatment for animals or the abuse of some species over others. They're a sad sight. They only entrench animal abuse. They're slow to speak up for small mammals or reptiles, if at all, but quick to shout for the release of great apes because they know there's little risk of antagonism since people are generally sympathetic to great apes.
You don't ask an abuser who beats a child to beat the child less. He's wrong to beat the child at all and must stop. Whether it's cowardice or an inherent human bias against animals, those who speak publicly for animals deliberately don't say that one species (us) has no right to overpower another. To keep silent about this is to willingly take part in animal abuse by not challenging it. It's not enough to only not beat children yourself. A responsible person opposes child beaters.
Amen, brother!
Each day for hours I pray for the world to go vegan and tweet about Gary Francione's wisdom. But I draw the line at crazy total liberation radicals who take action to help animals. Though that stops animal blood from being spilled, I can't disrupt my busy potluck schedule and Pangea shopping. You radicals do vegan activism your way, I'll do mine my way. You care only about violence from vivisectors. It's violence but it's legal. Breaking cages is not. We have to endure and hope to change the law. It's unfortunate such patience leaves a wake of dead animals, but law is sacred to me. Therefore property is sacred. If lots of people saw through the vivisection hoax and forced vivisectors to go out of business as only lots of people can do, yodas such as Gary would disappear in my lifetime. His books and podcasts make me feel good. Repetition is nicest the third or fourth time. Radicals want everyone to build a society based on compassion and free thought. That's hard work, too impractical for this realist. If we allow wise guidance from yodas, we won't have to live through the uncertain upheaval of change. That would be more than inconvenient. I have faith in the next generation, or the one after, to make a real change for animals. Did I mention Pangea has really, really neat stuff?
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It sounds like a stage name for a gay porn star.
This alleged " doctor " makes numerous and verifiably false claims in this sense free rant.
RE: "Adverse drug reactions are the fourth leading cause of death ."
This is such obvious BS as to be taken as intentional fraud.
RE: "many drugs in use today were approved prior to animal testing . Included in this category are morphine, nitrous oxide, and digitalis"
This is disingenuous to say the least. Regardless of how these drugs were originally tested, there is no dearth of animal studies on the substances.
RE: " animals are not assessed to predict subjective reactions to drugs such as nausea, headaches, dizziness, and so forth—which also happen to be some of the most common side effects"
Another lame brained comment. Nausea observed as vomiting, dizziness observed as loss of balance, and headache or other pain observed as lethargy are all readily identified in animal models - not to mention a host of other clinical signs.
I'll briefly touch on several other hopelessly half witted claims by this alleged doctor. Unsafe drugs going to market with FDA approval has NOTHING to do with failed animal models. It has everything to do with a corrupt FDA, deep in the hip pockets of pharmacoms. Adverse side effects are typically well defined before drugs go to market. The problem there is most prescribing physicians never mention them to patients. Like the FDA, most medical doctors are deep in the hip pockets of pharmacoms.
The most glaring inanity of this alleged doctor is his disingenuous lack of understanding of drug trials. If the most serious side effects are observed in animal models, those substances NEVER advance to human trials, and certainly never go to market.
The bottom line in this alleged doctor's every post is that serious professionals refuse to waste their time debating with such an obvious fool. Far from being somehow dishonorable, any sane person would see this as being to their credit. As the saying goes, if you argue with a fool, what does that make you?
Perhaps Doctor Greek has a calling in the gay porn industry, but as a medical doctor (if he is one), he's a pretentious quack.
Vivisectors and pro-vivisectors always use the same stupid way to make a potentially dangerous other (Dr Greek in this case) look like it is nobody. Sometimes they are going to make a point if you have a grammar error.. when the important point is about the value or no value, of experiments with animals to find the cure to our diseases.
You refer him as if he has something to do with the gay porn industry.. because his name is Greek? What kind of idiot are you? Maybe you have ties with such industry.
Vivisectors are just liers who found a way to make easy money killing animals .. and people. If you are "interested" you can find drugs that come from this useless " research " that are retired, and the problems of such new drugs . This is not Science!.
It is not convenient for any damn vivisector to cure human diseases. Just the begining of their dirty work is a failure: to inject a human disease in another species. Ignore the origin of the disease is a huge mistake that vivisectors should know .
There are many important reasons why we can't believe in this "kind" of research. How to trust in someone who do not value life at all? If you are a scientist your mind should be open, not so narrow as to keep affirming that you are saving lives.. because you still do not have the cure to cancer . . after so many years, so much money, and so many lives...
No, vivisectors are not studying our diseases to find a cure. They enjoy abusing of animals and people who believe in them. After all , they do that and receive lots of money.
Do you care enough to stop using any product that contains substances tested on animals ? Or are you just another loudmouthed hypocrite that is more than happy to use products that were tested on animals to make sure they were safe for you to use?
Could you boycott those products for even as little as 30 days? Or are you all blow and no go?
I'll help you out to get you started on your holy crusade. This link will let you check virtually every chemical you may find listed on every label of every product you use.
http://toxnet.nlm.nih.gov /
The above site has a very good searchable database. Just type in the name of a substance and check to see if it has been tested on animals. If it has been tested on animals, and if you are something other than a loudmouthed hypocrite, obviously you wouldn't want to use it.
As the saying goes, the blood of the butcher is on the hands of the man who eats meat . How much blood is on your hands? How much of your consuming dollar goes to fund the research you claim to object to?
My guess is you are typical of the pseudo activist, who engages in a lot of pompous loudmouthism, while happily taking every advantage of the things you condem. You love your car and the gas it burns, but complain about off shore drilling . You love being able to plug your electric devices into the wall, but make a lot of noise about the loss of habitat behind the hydro electric dams. You love your wood house and the shelter it provides, but sneer at the logging industry. And, if you become sick, you could care less how many animals were sacrificed to test the medicine that will make you well.
So, put up or shutup. 30 days without using any animal tested products or substance. That shouldn't be too hard for a true believer, such as yourself, now should it?
I do not put up and I won't shutup. This country is not comnist. And I boycott everything I know come from the torture , suffering and killing of animals . But the word activism should not be confused with extremism, as many animal killers pretend to make us believe. Hypocrisy is when you have the choice to do something according to your beliefs, and you do the other option. I do understand people who fish, for example, AND EAT THEIR FISH. I am against hunters, they want to feel they are macho men, armed to their teeth, against animals that are bred to die, like canned hunts. None of you, pro-vivisectors, say anything against that. None of you says anything against the useless torturous life and death of animals for fur . Who needs fur? There is no comparison between the federal money that goes to vivisection and the real scientists. That is why there are more people supporting the real research . And yes, you can live 0 days and many more without products tested (uselessly) on animals. Thos tests are not required by the government , but as long as it is not banned will continue, as an extra-money for the animal killers.