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Covance spars with animal rights activists

Madison, Wis. - The building of a state-of-the-art medical research facility that could help pharmaceutical and biotech companies test the safety of new drug candidates is being challenged by a vocal contingent of animal rights activists.

Slated for construction in Chandler, Ariz., the proposed facility represents the next significant capital investment for drug development giant Covance Inc., following the recent expansion of its facilities in Madison.

Amid its preparations for the gambit of committee meetings and public hearings designed to dissect the merits of the plan, Covance has contended with protest groups stirring debate around issues such as animal welfare, possible environmental biohazards, and traffic congestion.

Covance, one of the world's largest drug development service companies, estimates that it has helped develop one-third of all pharmaceuticals on the market today. The Chandler facility would significantly enhance that established presence in the multi-billion dollar drug research market.

The project exists in an early and uncertain phase. As the public relations contest escalates to sway concerned residents, conflicting indicators of public opinion on the facility have done little to predict how Chandler's elected officials will respond to the plan once it is put to a vote.
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Covance already has purchased an $8 million site and is presently seeking zoning approval to begin construction. The site is strategically located, providing expanded access to the western U.S. pharmaceutical and biotech corridor, and close proximity to a strong life-sciences talent pool from the University of Arizona and Arizona State University.

"Right now we're committed to this location," Wendel Barr, senior vice president for Covance, told the Chandler Connection last month. "Chander is our first choice. This is where we want to be."

The move has provoked a renewed flurry of protest campaigns led by People for the Ethical Treatment of Animals (PETA), with direct support from the Physicians Committee for Responsible Medicine and The Animal Defense League of Arizona.

The ensuing debate has raised questions about the efficacy of federal drug approval regulations, standards for measuring pharmaceuticals in groundwater, and the integrity of the activist organizations themselves. But what seems clear is that the facility could bring a lot of money into the community.

Economic impact

In addition to developing new and potentially life-saving medicines, the first phase of the facility would offer approximately 400 jobs - most of which would be life-science jobs, including study managers, directors, lab technicians, and pathologists.

According to impact estimates from the Greater Phoenix Economic Council, the total direct personal income of these jobs would be $10.6 million in 2006. By 2010, an upgraded facility would support 700 jobs and would have injected an accumulated total of approximately $7.6 million in direct revenue into the region.

In an August letter to Mayor Boyd Dunn, city manager Mark Pentz and other signatories urged city representatives to embrace the Covance plan. "It is the [Chandler Chamber of Commerce]'s belief that Covance will have a positive impact on our local economy in the way of providing high-level jobs as well as continue to build upon Chandler's foundation to attract other responsible, credible, and respected bio-engineering firms to our community," he wrote.

A grassroots outcry?

Activists alleging "grotesque animal cruelty" and a "history of deadly toxic exposures" by Covance have made several attempts to persuade citizens to withdraw their support.

PETA's web-based campaign, CovanceCruelty.com, depicts images of caged and screaming Macaques. The site's visceral centerpiece hinges on compiled video footage obtained between April 26, 2004 and March 11, 2005 by PETA operative Lisa Leitten, an investigator hired as a technician to infiltrate Covance's laboratory in Vienna, Va. The footage contains unsteady, muffled scenes of technicians restraining frenetic test monkeys.

In October 2005, the Circuit Court of Fairfax County ordered PETA to stop infiltration activities for a period of five years. Then, in March 2006, the U.S. Food and Drug Administration and U.S. Department of Agriculture completed an investigation of the Vienna facility, issuing 16 citations - none of which were declared to be pervasive or endemic problems. Covance settled the matter with $8,720.

An online petition created by Michael Carbajal called "Stop the building of Covance Laboratories in Chandler" had garnered 5,496 digital signatures by the time of publication. Despite the negligible legitimacy of numerous signatures (posting requires only a name and e-mail address), some entries appear to independently and genuinely resonate PETA's anti-Covance campaign.

In the most recent entry that included a home address, Deanne Norton of Flagstaff wrote: "Just horrible, we need to stop these monsters."

In contrast, a Public Opinion Strategies poll commissioned by Covance suggests that 62 percent of Chandler residents favor the construction of the facility. The company release noted, "While some residents have reservations about animal testing, a total of 80 percent still support the facility."

Alternatives to animal testing?

Testing drugs on animals in preclinical trials is a federally mandated procedure but critics claim that it is also an outdated one.

Alka Chandna, senior researcher at PETA, cited a March 2004 FDA report titled “Challenge and Opportunity on the Critical Path to New Medical Products,” which states: “A new medical compound entering Phase 1 testing, often representing the culmination of upwards of a decade of preclinical screening and evaluation, is estimated to have only an eight percent chance of reaching the market.”

“The fact that only eight percent of drugs that enter Phase I actually make it to the human market means that 92 percent of the drugs found to be safe and effective in animals were found to be either unsafe or ineffective in humans,” Chandna said.

She cited alternatives such as the "Hurel chip" under development at Cornell University. This and other non-animal testing technologies have been shown to mimic the biological functions of living organisms but are not currently available as commercial applications.

Chandna suggested that development of alternative drug testing technologies has been stunted by corporate influence and the absence of political will.

“The technologies have to be validated by the FDA, and the validation process is highly political and, for people like us, very frustrating,” she said. “Our government is dragging its feet at the behest, I would say, of pharmaceutical interests. And that comes at the cost of not only animal lives but human lives.”

Related stories

Covance Appoints Co-Presidents for Early Development Services

Tom Still: Animal testing: Beyond the protests, instances of mistreatment are rare

Cancer treatment advances as trials show no harm to mice

Comments

Norman Levitt responded 8 years ago: #1

The trouble is that this piece resorts to the specious "even-handedness" that characterizes all too much of the coverage of scientific and technical issues. In particular, the strained and sometimes ridiculous arguments of PETA and its fellow-travelers to the effect that animal testing is irrelevant to human health issues are cited as though they characterized a body of serious scientific opinion. There is no serious doubt amongst biomedical researchers studying a host of vital questions that animal subject research is indispensible to the growth of accurate clinical and theoretical knowledge.

To put it bluntly, without such research, millions of people, at the least, would be needlessly condemned to suffering and even to death, disasters that the relevant and accurate research work with animals can and hopefully will prevent. The "arguments" to the contrary presented by PETA and its friends are rationalizations, concocted from whole cloth, framed to support an ideological commitment already established. None of this stuff constitutes an independent conclusion derived from actual evidence.

If PETA and Co. had the guts to concede that they oppose animal research regardless of the human toll that will result from ending it, one could at least respect their integrity if not their ethical priorities. But, knowing that the vast majority of people regard their children's health as more important than the fate of lab rats, PETA and similar outfits prevaricate and lie outright in order to win a measure of public sympathy on this issue. Reporters who cover this kind of story out to be dilligent and astute enough to point this out.

Gayle Dean responded 8 years ago: #2

Norman Levitt wrote:

"There is no serious doubt amongst biomedical researchers...that animal subject research is indispensible...

"...without such research, millions of people, at the least, would be needlessly condemned to suffering and even to death..."

I have two points about this:

First, there is considerable doubt among reputable scientists about the value of animal research. In fact, in January 12, 2006 the FDA issued a press release in which Health and Human services Director Mike Leavitt made the following statement:

"Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies."

Second, even if animal testing turned out to be of value to humans, this still does not address the important moral questions. Animal researchers, like Mr. Levitt, insist that animal-testing is vital for finding treatments for the millions of people with chronic diseases like cancer, diabetes, and heart disease, and they believe animal sacrifice is morally required to save these sick people. Setting aside whether animal testing yields good results for treating human disease, many people accept this moral justification without question.

Inevitably, they will say: "I'll bet you sing a different tune when you have cancer!"

But there is a big ethical problem:

The diseases that cause most of the illnesses and death in the United States are chronic diseases like cancer, diabetes, and heart disease. And these diseases are most often due to lifestyle choices, which means they are largely preventable.

According to the American Cancer Society:

"Tobacco use, physical inactivity, obesity, and poor nutrition are major preventable causes of cancer and other diseases in the US. The American Cancer Society estimates that in 2006, more than 170,000 cancer deaths will be caused by tobacco use alone. In addition, scientists estimate that approximately one-third (188, 277) of the 564, 830 cancer deaths expected to occur in 2006 will be related to poor nutrition, physical inactivity, overweight, and obesity."

This means that roughly two-thirds of all cancer deaths are due to lifestyle choices, and thus are preventable. The American Heart Association concurs, holding that heart disease is "mostly preventable." The American Diabetic Association publishes similar estimates and analysis. In other words, the major killer diseases are largely self-inflicted. And those estimates don't even include less deadly afflictions like arthritis, ulcers, cataracts, or common ailments like flus, colds, and allergies, etc. - many of which are also caused or exacerbated by diet and lifestyle.

People know all this, but still refuse to stop smoking, change their diets, lose weight, or make other beneficial lifestyle changes. Doctors suggest all these "cures" in a casual way, but they know most people will not make the recommended changes. As members of the instant-gratification generation, people would rather abuse themselves now, and call on doctors later, to prescribe the newest little purple pill or perform the latest heart-bypass procedure to treat problems that could have been prevented in the first place.

The serious ethical question is: why should millions of innocent animals be tortured and sacrificed to find treatments for largely self-inflicted diseases in people who refuse to take responsibility for their own choices?

Granted, some people make responsible lifestyle choices and still get disease. But if we accept scientists' estimates that two-thirds of the major diseases are preventable, we could at least significantly reduce animal testing. The majority with self-inflicted chronic diseases must face the moral dilemma. It should not just be accepted without question that when people are irresponsible, animals can be tormented and sacrificed to save them.

We never hear researchers or animal-testing advocates address this ethical question. Why not? Well, one answer is that there is not a lot of money in seriously promoting prevention, so doctors and pharmaceutical companies are happy to oblige their patients. An entire mega-industry is built upon this kind of irresponsibility and greed, and it rides on the backs of animals.

Gayle Dean

Mark Terrance responded 8 years ago: #3

"Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies."

This is nothing more than a way of distorting reality with statistics. What, exactly, does the fact that 9 out of 10 drugs fail in clinical studies have to do with the effectiveness of animal testing?

Let's say you start with 100 possible drugs and run them all through animal testing, where 90 are eliminated. 10 left. Now you run them through clinical trials, where 9 more don't work. 1 left.

9/10 were eliminated in clinical trials -- but that doesn't mean animal testing did nothing. Without it, you would have had to run 90 more drug tests on humans.

And here's the thing: Researchers are already running low on human volunteers to test all the new drugs coming out.

john winston responded 8 years ago: #4

If animal research is so good, how do you explain the following court rulings?

1. There are inherent problems in relating the results in animal studies to the human experience. Some substances cause cancer in man which, when given to animals, induce little or no response. Researchers have had particular difficulty inducing disease in animals exposed to asbestos, while there is little doubt that human exposure may result in disease. U.S. v Reserve Mining Company, 380 F. Supp. 11; 1974 U.S. Dist. LEXIS 8891.

2. "It is also difficult to extrapolate findings from animal studies to human studies because of the large dosage used in the animal studies. . . . Almost any substance can be shown to be teratogenic at some dose in some species." Lynch v. Merrell National Laboratories, 646 F. Supp. 865, (1986) aff'd, 830 F.2d 1190 (1st Cir. 1987).

3. The court held the evidence insufficient to provide support for an opinion on causation because the expert acknowledged that the effects of chemicals differ between humans and rats. Viterbo v. Dow Chemical Co., 826 F.2d 420 (5th Cir. 1987).

4. In a jointly-authored article, Dr. Ellen K. Silbergeld writes that "laboratory animal studies are generally viewed with more suspicion than epidemiological studies, because they require making the assumption that chemicals behave similarly in different species." Hall & Silbergeld, "Reappraising Epidemiology: A Response to Mr. Dore," 7 Harv. Envtl. L. Rev. 441, 442-43 (1983). In re "Agent Orange" Prod. Liab. Litig., 611 F. Supp. 1223, 1241 (D.N.Y., 1985).

5. Judge Weinstein has recently expressed the view that the probativeness of animal studies does not outweigh the danger of misleading jurors. In Agent Orange, 611 F. Supp at 1241.

6. Dr. Done also acknowledged that in vivo (animal) teratology studies are similarly of but scant utility in drawing conclusions about whether a substance will cause birth defects in humans. "The fact that [a substance does so] in an animal," he conceded, "doesn't necessarily mean it will in humans. Richardson v. Richardson-Merrell, Inc., 273 U.S. App. D.C. 32 (D.C. Cir., 1988).

7. In a pesticide exposure case, Judge Kosik excluded expert testimony premised on animal studies under Rule 702 because those studies are "grossly conjectural" and therefore could not assist the trier of fact. Selwood v. Oxford Chemicals, Inc., No. 90-1048 (M.D. Pa. June 28, 1991).

8. The animal studies are not helpful in the instant case because they involve different biological species. They are of so little probative force and are so potentially misleading as to be inadmissible." 611 F. Supp. at 1241 (citations omitted). In re Paoli R. Yard PCB Litigation, 1992 U.S. Dist. LEXIS 16287 (D Pa., 1992).

9. The court found that animal studies were of limited reliability when attempting to relate those studies to humans. In re Paoli R. Yard PCB Litigation, 1992 U.S. Dist. LEXIS 16287 (D. Pa., 1992).)

10. “…excluding the testimony where the record failed to make clear how the animal studies were sufficient to show that Bendectin causes birth defects more probably than not.” Turpin v. Merrell Dow Pharm., Inc., 959 F.2d 1349, 1360 (6th Cir. 113 S. Ct. 84 (1992).

11. Plaintiffs' case relied on animal studies and claimed that because an ingredient in Bendectin, doxyatamine succinate, interfered with cartilage cell formation in animals, Bendectin was capable of causing similar limb defects in humans. Because plaintiffs' experts testified only that Bendectin was capable of causing or could cause plaintiff daughter's birth defects, and not that it probably did, plaintiffs' evidence was insufficient. Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349 (6th Cir., 1992).

12. The weakness of the (losing) plaintiffs' case results from the care with which reputable scientists use animal experiments to predict causation in humans. This weakness arises from the fact that different species of animals react differently to the same stimuli for reasons not entirely understood. They testify that the animal studies show that Bendectin is "capable of causing," "could cause," or its effects are "consistent with causing" birth defects, not that it probably causes birth defects in general or that it did in this case. The evidence cited in support of his conclusion is insufficient to meet the plaintiffs' burden of proof. Turpin v Merrell Dow Pharmaceuticals, 959 F.2d 1349; 1992 U.S. App. LEXIS 4143.

13. Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Daubert v. Merrell Dow Pharms., 509 U.S. 579, 584 (U.S., 1993).

14. This court found the (animal studies) evidence to be admissible, we believe, but that it presented too wide an "analytical gap" for reasonable inferences on causation "to be drawn on the ultimate issue of human birth defects." Turpin, 959 F.2d at 1360, Elkins v Richardson-Merrell, Inc. 8 F.3d 1068; 1993 U.S. App. LEXIS 27128.

15. This Court observes that studies of laboratory animals are routinely excluded as irrelevant and unreliable when proffered as a basis for medical causation testimony. Joiner v. General Elec. Co., 864 F. Supp. 1310, 1323 (N.D. Ga. 1994).

16. The Supreme Court criticized plaintiffs’ reliance on animal studies as a basis for establishing causation, stating that there was no explanation “how and why the experts could have extrapolated their opinions from these seemingly far-removed animal studies . . . .” Joiner v. General Elec. Co., 864 F. Supp. 1310, 1323 (N.D. Ga. 1994).

17. “‘The high doses customarily used in animal studies’ make extrapolating the effect on much lower doses in humans very difficult to determine.” Thus, the court held that animal studies may not be used to establish causation. Dunn, 275 F. Supp. 2d at 683.

18. To ensure that the expert's conclusion based on animal studies is reliable, there must be "a scientifically valid link" - such as supporting human data - "between the sources or studies consulted and the conclusion reached." Cavalo v. Star Enterprise, 892 F. Supp. 756, 762 (E.D. Va. 1995)

19. At best, "animal data can demonstrate the possibility of an effect, but they cannot carry the same weight as studies conducted in people or in human tissues." The animal studies relied upon by plaintiffs experts are not sufficient evidence, either alone or in combination with other evidence. Soldo v Sandoz Pharmaceuticals 244 F. Supp. 2d 434; 2003 U.S. Dist. LEXIS 2516.

20. Does Dupont’s fungicide Benlate cause birth defects? Plaintiffs’ experts relied largely on animal studies. In a 50-page opinion, the judge dismissed the case for lack of evidence. On appeal, the Fourth Circuit agreed. Bourne v. E.I.DuPont de Nemours and Company, 2004 U.S. App. LEXIS 1161 (4TH Cir. 2004).

Gayle Dean responded 8 years ago: #5

Mark Terrance isn't paying attention. Leavitt is trying to move drugs to clinical trials faster and with less animal testing. The quote said that "nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies." Notice that word, "because." We cannot predict how the drugs will behave in humans on the basis of animal experiments. Leavitt was clear what this meant. The purpose of the press release was to announce new rules that would reduce the amount of animal testing required before drugs go to clinical trials.

And here's the thing. If we cannot predict drug effects in people from animal tests, it doesn't make sense to test in even more animals - no matter how short the supply of human volunteers is.

And just as I predicted, Terrance didn't respond to the moral question about why millions of innocent animals should be tortured and sacrificed to find treatments for largely self-inflicted diseases in people who refuse to take responsibility for their own choices?

Gayle Dean

Rick Bogle responded 8 years ago: #6

Fleissner reports: "But what seems clear is that the facility could bring a lot of money into the community."

To many business leaders and politicians this is all that matters. They don't want to be confused by the facts.

An aside, since this is a Wisconsin-focused page: UW-Madison just destroyed 60 boxes of video tapes documenting years of their experiments on monkeys rather than allow the public to view them. This is an affront to democracy and basic science.

It speaks volumes about how unimportant and embarrassing they find their own work to be.

Rosalind Dalefield responded 8 years ago: #7

Covance has a lot of competitors that do the same sort of preclinical toxicology testing. If Covance doesn't expand, the development of new drugs will not be impaired in the slightest. The work will simply be placed with other existing contract research laboratories. If, as media quotes suggest, Covance or its supporters are claiming that medical science would suffer if the company is not allowed to expand, that is being misleading. The only losers, if the Chandler construction does not go ahead, are Covance's stockholders.

stephen responded 7 years ago: #8

id rathar hang out with any animal over people. when are we gonna wake up? there is a change happening on earth for the better, but it gonna get a lot worse before it gets better.
eat healthy, dont smoke, exercise. there is your solution. dont rely on drugs to fix your self induced problems.
its a mega big business. why support it? dont buy asprins for your headaches etc etc. buying that stuff means we support them.
i cannot believe that people can be so cruel.
NO TESTING. id rathar die than have all those animals tested on. be responsible for your own actions.

stephen responded 7 years ago: #9

the bottom line is, its not right. theres no argument, everyone can go home.
the people who think up what tests to do on animals and that do it - theyre the ones who need examining. HELLO!! WAKEY WAKEY

Doden til Animal Activist responded 7 years ago: #10

The death of animals is wrong, BUT if it saves the my life as well as my family who cares? Animal activists are childish losers with nothing better to do.

Come on people, grow up. I love animals, but its better them than us. If you would rather your life be taken instead of animals, then by all means take it, who gives a [bleep]? I dont. ALSO, not all mental and health issues are self-inflicted. I have anxiety,
and I'm happy they made Xanax, regardless of how many animals'lives it took. We'll see how you feel when your closest family member dies, when their life could have possibly been saved by medicines.

One other thing... you so-called activists don't use anything that has not been tested on animals, but yet basically everything known to man has at some point been tested on animals, from clothes to food to medications. You all are a bunch of hypocrites, seriously. Im sure there are countless times when you have at some point taken medication or been in the hospital and had Lactate Ringers through your veins asw ell as 50 percent dextrose and Sodium bicarb. Also when you go to the dentist, have had some form of injection to
numb your mouth. Think about it. Just because an item says "Not tested on animals" does not mean it hasnt been. Pretty much all the chemicals have at some point been tested on lab animals.

Although I'm sure all of you are stubborn idiots like Christians who will never change their minds on their beliefs, just live life to its fullest and enjoy it while it lasts. Don't waste time and effort on this [bleep]. I love Ruesus, Mauritius Cynos, and Asian Cynos. But in the end, these animals' lives are taken for a good cause. They help cure the problems humans have on a daily basis.

D responded 7 years ago: #11

Also, I must add:

As far as PETA and Covance Cruelty.com goes...

Those videos are not even as bad as they TRY to make them seem. The tubes fed down the monkeys throats are actually peptobismo, septra, lactated ringers, and other medications to cure diarrhea and other complications these animals face.

They make it seem like it's so bad. They save the animals lives on a daily basis from giving IVs to treatments. My boss says very often, "Treat these animals with the best care and make their time spent in our facility as best as possible. This is the last place they are before reaching their last destination" and that's true, and we do treat them well. Covance is a great company and I feel that they are doing good for mankind.

Steven McLean responded 7 years ago: #12

Hi Doden til animal activist... you mention that the death of animals is wrong!! May I congratulate you for at least getting something right! You then go on to state: "But if it saves the my life as well as my family who cares? My response to that is .. you should care!!!

You then go on to state,"Animal activists are childish losers with nothing better to do."
I assure you we animal activists are not in any way childish .. and we certainly aren't losers!!! The only losers are the poor defenceless animals that die due to the cruelty inflicted on them in the labs in the supposed name of science... and of course... people like yourself and your family that you claim to care so much about!!

Why dont you wake up? Do your homework. Do your research. Don't try to criticize those who are trying to preserve both human and non-human life by stopping vivisection.. until you become better informed on the subject!!

Oh, and as for us being losers, well we come from all walks of life... from all corners of the globe!! We are scientists who are well aware of the facts (unlike yourself), we are doctors, we are nurses, we are surgeons, we are teachers ect. We certainly aren't losers!!!

STOP BEING A LOSER YOURSELF!! DO YOUR RESEARCH, THEN COME BACK WHEN YOU ARE BETTER INFORMED!!!

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