USDA subverts Animal Welfare Act in whistleblower protection case

Ron Wood's crack-smoking experiments. A case study of waste, fraud and animal abuse

"Scientific Welfare" needs reform. Wasteful, irrelevant and cruel research underwritten by U.S. tax dollars

Retaliation Case of
Jan Moor-Jankowski, M.D.

Top Ten Lies of the Department of Agriculture
In the matter of animal welfare whistleblower - Jan Moor-Jankowski, M.D.

The History of Medical Progress written by Dr. Ray Greek, Director of the Medical Research Modernization Committee

"If I, an internationally recognized scientist and consultant to heads of state and national academies, couldnot secure protection under federal law, how can U.S. citizens believe thatanyone, let alone younger, lesser-known scientists, dare to oppose scientificmisconduct, animal abuse and the misdeeds of corrupt administrations?"- Jan Moor-Jankowski, M.D.

ACTION is part of Agency's long-standing pattern of failure to uphold the law.

The History of Medical Progress
written by Dr. Ray Greek, Director of the Medical Research Modernization Committee

Introduction | Surgical Advances | Medication Testing in Animals | Curing and Preventing Cancer |Do Animals Feel Pain? | AIDS Research with Animals
Heart Disease | Cardiovascular Disease | Childhood Diseases | Birth Defects

Medication Testing in Animals
Where would we be without the ability to test new medication on animals.Would we all become guinea pigs? Aren't animals used to see if medicationsare safe? Aren't animals used to figure out the correct dose to give humans?What about the bad side effects? Doesn't animal testing find out which medicationsare dangerous?

Between 1976 and 1985, 209 new drugs were approved for use in the UnitedStates (US) after extensive animal testing. Of these 209, 198 were followedfor side effects and effectiveness by the Food and Drug Administration (FDA).(Sometimes a drug will be approved but never make it to market secondaryto the fact that the drug company ceases to believe it can make money offthe product. Sometimes these drugs are referred to as "orphan drugs.")102 of the 198 new medications or 52% were either withdrawn or relabeledsecondary to severe unpredicted side effects. These side effects includedcomplications like lethal dysrhythmias (when the heart beats without a regularrhythm, thus severely limiting the amount of blood it can pump), heart attacks,kidney failure, seizures, respiratory arrest (when one stops breathing andsubsequently the heart stops beating as well), liver failure, stroke andmany more. All these medications had been tested on animals. What happened?
In 1933, a physician stated, "...the results of drug experiments uponanimals are, as far as their application to man is concerned, absolutelyuseless and even misleading."
And in 1967, Dr. Arnold D. Welch, Department of Pharmacology, Yale UniversitySchool of Medicine, stated,
"In part because of possible major differences in responses to drugsin animals and man, the knowledge gained from studies in animals is oftennot pertinent to human beings, will almost certainly be inadequate, andmay even be misleading."
Other scientists are now going on record stating that there is only a 5-25%correlation between animals results and human results. This is less accuratethan tossing a coin. At least with tossing a coin you have a 50% chanceof success. What about predicting the correct dose of a drug for humans?
The dose of a medication is determined in part on how the drug is metabolized.A study of 23 chemicals revealed only 4 were metabolized the same way inhumans and rats. These differences prompted one scientist to state,
"It seems incredible that the rat is the model so heavily relied uponwhen predicting human responses to toxic/carcinogenic agents. Whether theconcern is absorption, tissue distribution, biliary excretion, intestinalflora, enterohepatic circulation, and others, there are profound differencesbetween the values of the rat and those of humans."

So animals can not accurately predict dose, side effects or toxicity tohumans. What about all those drugs that did not pass animal tests? Aren'twe much safer because the really bad drugs were caught early? Dr. Kurt Fickentscherof the Pharmacological Institute of the University of Bonn, Germany, inDiagnosen, stated in March 1980,
"Normally, animal experiments not only fail to contribute to the safetyof medications, but they even have the opposite effect."
Digitalis, like many medications, was discovered without animal use. Itis derived from plants and has been used by herbalists for centuries. However,clinical trials of the drug were delayed secondary to the high blood pressureit caused in animals. Digoxin, an analogue of digitalis has saved countlesslives. How many more could it have saved had digitalis been released sooner?
FK 506 - a chemotherapeutic agent was almost shelved before proceeding toclinical trials. Researchers stated,
"Animal toxicity was too severe to proceed to clinical trial".
They suggested that the combination of FK 506 with cyclosporin may provemore useful. In fact, just the opposite was to be true in humans.
Perhaps the most useful medication that was almost lost secondary to animalexperimentation was penicillin. Flemming saw penicillin kill bacteria inpetri dish and tested it on rabbits. It did not work. Rabbits excrete penicillinin their urine. The drug does not get a chance to work prior to being eliminatedfrom the body. Flemming then discarded the drug thinking it to be uselessas a systemic medication. He later had a very sick patient and since hehad nothing else to try, gave the penicillin. The rest, as they say is history.It is good thing his initial tests were not on guinea pigs or hamsters,it kills them. He might have thrown the drug away entirely instead of settingit aside for possible topical use. His experience prompted him to state,"How fortunate we didn't have these animal tests in the 1940's, forpenicillin would probably never been granted a license, and possibly thewhole field of antibiotics might never have been realized".
Dr. Howard Florey, the Nobel Prize winner who is credited with co-discoveringpenicillin, has stated: "Mice were used in the initial toxicity testsbecause of their small size, but what a lucky chance it was, for in thisrespect man is like the mouse and not the guinea-pig. If we had used guinea-pigsexclusively we should have said that penicillin was toxic, and we probablyshould not have proceeded to try and overcome the difficulties of producingthe substance for trial in man."

An oft repeated horror story of how animal testing could have saved patientsis the story of the thalidomide disaster which occurred in the late 1950sand early 1960s. In fact just the opposite is true. Thalidomide was originallyintended to decrease severe morning sickness associated with pregnancy.Unfortunately, it also caused a condition known as phocomelia; a congenitalabsence of the limbs. Thalidomide was tested on animals both before andafter the side effects were known. The severe birth defects were not onlynot predicted by animal tests before the disaster, but even when the scientistsknew what they were looking for, only one particular breed of rabbit anda few primates were found to reproduce the deformities. This is usuallythe story with animal experiments. Eventually you can find an animal whichpredicts the side effect, but only after you know what the side effect isand have looked for it in many different species of animals. That is essentiallythe point of those who oppose animal research. Look long enough and hardenough and you will find some animal somewhere which does react to medicationthe way humans do. Only problem is, in order to know if the side effectin question is accurately predicted by the mouse or dog, or cat or woodchuckor whatever, you must have already tested the medication in humans. Withsome medications the White New Zealand rabbit will predict problems accurately.With others the mouse may be predictive. But if we only know in retrospect,why perform the test? That's like having the answer to the test questionsbefore the teacher gives the exam. Real life doesn't work that way. Youare not getting new data, but merely "validating" data alreadyknown to be true from humans. Why does science feel they must "validate"data on animals to prove that the effects already observed in humans reallyoccurred?

Mice and rats were tested and not effected by thalidomide. The White NewZealand rabbit was effected only at a dose of 25 times that given to humans.Monkeys were effected at 10 times the normal dose. Two scientists summarizedthe thalidomide testing as follows:

"An unexpected finding was that the mouse and rat were resistant, therabbit and hamster variably responsive, and certain strains of primateswere sensitive to thalidomide developmental toxicity. Different strainsof the same species of animals were also found to have highly variable sensitivityto thalidomide. Factors such as differences in absorption, distribution,biotransformation, and placental transfer have been ruled out as causesof the variability in species and strain sensitivity."

There is law in medicine which states that any substance can cause birthdefects if given to the right species in the right dose at the right timein development. That is certainly true with thalidomide. One scientist stated,
"In approximately 10 strains of rats, 15 strains of mice, 11 breedsof rabbits, 2 breeds of dogs, 3 strains of hamsters, 8 species of primatesand in other such varied species as cats, armadillos, guinea pigs, swineand ferrets in which thalidomide has been tested, teratogenic effects havebeen induced only occasionally."
He goes on to state:

"It is the actual results of teratogenicity testing in primates whichhave been most disappointing in consideration of these animals' possibleuse as a predictive model. While some nine subhuman primates (all but thebush baby) have demonstrated the characteristic limb defects observed inhumans when administered thalidomide, the results with 83 other agents withwhich primates have been tested are less than perfect. Of the 15 listedputative human teratogens tested in non-human primates, only eight werealso teratogenic in one or more of the various speciesThe data with respectto "suspect" or "likely" teratogens in humans undercertain circumstances were equally divergent. Three of the eight suspectteratogens were also not suspect in monkeys or did not induce some developmentaltoxicity.
Over 10,000 children were crippled as a result of thalidomide. This tragedyis made worse by the fact that a physician observed the link between thalidomideand birth defects and sounded an alarm. He was ignored because of the animalexperiments which had proven that the medication was safe. Since the laboratorywas and is considered the true sanctuary of medicine, many individuals wereeffected by thalidomide who did not need to be.

Another scientist states, "There is at present no hard evidence toshow the value of more extensive and more prolonged laboratory testing asa method of reducing eventual risk in human patients. In other words thepredictive value of studies carried out in animals is uncertain. The statutorybodies such as the Committee on Safety of medicines which require thesetests does so largely as an act of faith rather than on hard scientificgrounds. With thalidomide, for example, it is only possible to produce specificdeformities in a very small number of species of animals. In this particularcase therefore, it is unlikely that specific tests in pregnant animals wouldhave given the necessary warning: the right species would probably neverhave been used. Even more striking, the practolol adverse reactions havenot been reproducible in any species except man."

Despite what those who earn their livelihood from experimenting on animalssay, animal tests would not have prevented the thalidomide disaster andin fact delayed the acknowledgment of it's severe side effects.

return to top | next page»