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

Birth Defects
Nelsons Textbook of Pediatrics states, "Much of our knowledge of fetalphysiology has been obtained from animals and often is not directly applicableto man." Birth defects continue to rise despite billions of dollarsin funding, both public and private. One cause of birth defects is medications.Animals have been used for years to study medications and birth defects.But do they accurately predict birth defects? Karnofsky's Law states anymedication or substance can be teratogenic (cause birth defects) if givento the right species, at the right time in development, in the right dose.Therefore, any medication can cause birth defects in some creature. In 1963the Lancet had the following statement:

"In fact, the pitfall is that, having found no teratogenic effect ina `sufficient number of different species of laboratory animals', one canstill not be sure of the effects on the human fetus, which is always theultimate purpose of investigation."

No where is this more evident than in the Physicians Desk Reference (PDR).The PDR is now an ubiquitous book both for the health professional and thelay public. Have you ever looked in it to see if a medication was safe touse in pregnancy? The answer is usually:

"Reproduction studies have been performed in rats, rabbits and miceat doses up to six times the human dose and have revealed no evidence ofimpaired fertility or harm to fetus due to the drug. There are, however,no adequate and well controlled studies in pregnant women. Because animalreproduction studies are not always predictive of human response, the drugshould not be used during pregnancy unless clearly needed." (1993 PDR)

Read through the PDR and see how many times this answer or a similar oneis written concerning a medication. Animal tests do not provide answer.One example of this is the medication aspirin. Aspirin is safe for pregnantwomen but causes birth defects in guinea pigs, monkeys, rats, cats, dogs,and mice. Streptomycin, insulin and penicillin are also safe in pregnantwomen while causing birth defects in animals. In 1978, Dr. Ralph Heywoodstated,
"There is fundamental lack of knowledge of pathogenesis of most malformationsand, therefore extrapolation to man has to be done with reservation andcare. Negative results cannot be used to predict that an agent will lackteratogenic effect in manSurprisingly few compounds have been shown to beteratogenic in man although a large number, including aspirin, steroids,vitamin A and B, insulin and hydantoin, have been shown teratogenic in rats."

In 1984, Dr. Lasagna stated, "False positives and false negatives abound.Once one has established that a drug is a teratogen for man, it is usuallypossible to find, retrospectively, a suitable model. By trying to predicthuman toxicity - which is after all what the screening game is all about- is quite another matter. Cortisone is a potent dysmorphogen in the rabbitand mouse, but does not produce malformations in the rat. Carbutamide producesmalformations in the eyes of rats and mice, but facial and visceral malformationsin rabbits."
The best example of this may be studies published in 1992. The FDA and Councilon Environmental Quality collected information yielding the following: Predictingteratogenicity is best accomplished in the following animal models: themouse model was correct 85% of the time, followed by the rat, 80%, rabbit60%, hamster 45% and monkey 30%. Sounds reasonable right? Unfortunately,when the same methods were used to predict substances which do not causebirth defects the list basically reversed itself: Mice and hamsters correctlypredicted the results 35% of the time, rats 50%, rabbits 70%, and monkeys80%. When you average the chance of predicting a teratogenic agent withthe chance of predicting a non teratogenic agent, the odds are about 50/50with every species. Flipping a coin will give a 50/50 chance. It does notcost any money to flip a coin. Scientists have recognized this for years.In 1980, Dr. Yaffe stated:
"Experiments with animals have yielded considerable information concerningthe teratogenic effects of drugs. Unfortunately, these experimental findingscan not be extrapolated from species to species or even from strain to strainwithin the same species, much less from animals to humans.

Birth defects affect 150,000 babies per year. The medical cost of caringfor children with birth defects is over $1,000,000,000.00 annually. TheCDC conducted a study between 1979 and 1989. They followed 38 birth defects.During this time period, 27 of the birth defects actually increased in theUS population. 9 did not change and only 2 decreased in incidence. So whatare scientists doing in order to curb this trend? The March of Dimes (MOD)has donated over $2.5 million dollars for the following: Scientists wantedto study the effects of cocaine on the learning of babies exposed to cocaine.Instead of studying human babies who are unfortunately born to mothers whoconsume cocaine, they decided to study pregnant rats. Scientists have unfortunatelytoo much data on this type of thing. But the MOD decided to fund this projectanyway. The scientists found that maternal cocaine exposure influenced thelearning of female rats but not male rats. Interestingly another study foundmale rats affected and not females. So much for studying learning in rats.The effects of cocaine are well documented in human babies. It is a totallypreventable birth defect. As taxpayers we are often told that our only choiceis the life of a lab animal or the life of a child. In fact our choice isgood science or bad science.

In the words of Dr. Anderson,

"It needs to be recognized that, as well as a personal tragedy forthe families concerned, congenital abnormalities now present a major publichealth problem. Evidence of an effect in rats is not also evidence of aneffect in humans."

One common sense approach to prescribing medications to a pregnant patientwould be to give the drug only if absolutely necessary. Although this issome what counter to our `take a pill' mentality, it would save many babiesfrom potentially dangerous medications. In the book, Monitoring for Drugsafety, Dr. Smithells states,

"In the absence of useful tests for teratogenicity clinicians haveto accept the responsibility for drug exposure in early pregnancyif clinicianswere more aware of the shortcomings of animal teratogenicity testing theymight take this responsibility more seriously."

Dr. Smithells continues, "The extensive animal reproductive studiesto which all new drugs are now subjected are more in the nature of publicrelations exercise than a serious contribution to drug safety."

And Dr. Hawkins, professor of Obstetrics, states,

"The great majority of perinatal toxicological studies seems to beintended to convey medico-legal protection to the pharmaceutical housesand political protection to the official regulatory bodies, rather thanproduce information that might be of value in human therapeutics."

Dr. George Lin wrote in the journal In Vitro Toxicology,
"there is no ideal animal model to extrapolate teratogenicity resultsto human exposure because of species sensitivity and species difference."
1.3 million mothers receive inadequate pre-natal care each year. Almostall, if not all, chemicals which cause birth defects were shown to do sosecondary to human epidemiology studies. The effects of thalidomide, FetalAlcohol Syndrome, fetal hydantoin syndrome, the effects of DES, the effectsof mercury, spina bifida and folic acid deficiency, fetal rubella syndrome,and others were all identified with epidemiological studies, not animalexperiments. The connection between maternal rubella and birth defects wasfound by epidemiological studies in Australia in 1941. Cataracts in newbornswere found to increase in incidence after a rubella outbreak. The effectof radiation on the fetus was discovered by epidemiological studies between1958 and 1962. The cancer causing effect of radiation to the fetus may havegone undetected in animal studies. The risk of too much oxygen in prematurebabies was discovered through epidemiological studies. The risk of retinopathyof prematurity, which causes blindness in newborns, can be diminished bygiving only as little oxygen as possible for as short period of time aspossible to premature babies. This does not always prevent blindness butit does lessen the chances of developing it.