Adventures in Ethics and Science

I’m not a regular reader of the Huffington Post, but I received a pointer to an article there that strikes me as worthy of comment.

The article, Why I Take Animal-Tested Drugs, was written by Simon Chaitowitz, the former Communications director for the animal rights group Physicians Committee for Responsible Medicine.

From the title, you might expect a defense of animal-tested drugs, or at least a coherent explanation for why the author is taking them. However, what the article actually offers is condemnation of the use of animals in biomedical research, and even a claim that animal-tested drugs and medical interventions contributed to the author’s cancer.

The truth is that I don’t feel I’ve ultimately benefited from our healthcare system, despite some truly exceptional care and many amazingly compassionate practitioners. Just the opposite.

I first developed myelodysplastic syndrome (MDS) in 2004 from the chemo I was prescribed for breast cancer. In 2006, I underwent a stem cell transplant, which gave me two years of remission (albeit with many horrible side effects). This past July, I relapsed — this time with acute myeloid leukemia (AML). My prognosis is grim.

Ms. Chaitowitz sought treatment for her breast cancer. Presumably, before she consented to the chemotherapy, she was informed of the risks of this treatment, including the possibility of developing MDS. As well, before consenting to the stem cell transplant, she would have been informed by her physicians of the possible side effects, ranging from mild to horrible. That she describes her care as “truly exceptional” and her care providers as “amazingly compassionate” communicates that she regards these physicians as having lived up to their ethical responsibilities to her as their patient.

At which point, Chaitowitz had the information to make her own choices and, having made those choices, she needs to accept her share of responsibility for the outcomes. Our healthcare system did not hold her down and force her to accept chemo or a stem cell transplant. They were offered and she accepted them. Not only did she have the option not to pursue these treatments, she also had the option to forego medical care altogether. (I would hazard a guess that Chaitowitz had good enough health insurance that she had the choice to access the care options she did — many Americans do not.)

Throughout the past six years, I have felt terribly guilty about the drugs and procedures I’ve undergone because I know that so many animals have suffered in their development. …

The truth — mostly hidden from public view — is that animal research is horribly cruel. Despite what the research community claims, federal regulations are extremely weak and poorly enforced, and some species — mice, for example — are completely excluded from any protection. Many investigations have shown just how bad conditions are.

Chaitowitz makes claims here that are overly strong and that fail to draw important distinctions.

First off, she seems to be claiming that all animal research is horribly cruel. Possibly it could be viewed this way by a person committed to the idea that non-human animals have enforceable rights (making all human use of animals wrong), but most people fall closer to the view that animal welfare (which includes freedom from unnecessary suffering) is what ought to be protected. From that viewpoint, there are many types of animal research that are far from “horribly cruel,” and even in the studies where animals are exposed to diseases, surgery, or death, the research protocols build in measures to reduce the distress and discomfort of the animals. If cruelty were the goal, such steps would not be taken. Indeed, that such steps are required indicates that as a group, scientists who do animal research and the federal agencies that oversee animal use are committed to making that research as humane as possible.

Next, there is the question of whether the federal regulations are too weak. I’m guessing that most of Chaitowitz’s readers at HuffPo have never read those regulations (for which you can find links here) and thus have no way to assess their strength or weakness. That mice are not covered species used in lab experiments does not, however, mean that they are treated more cruelly in labs than they are in kitchens and basements where they are poisoned, stuck on sticky-traps, or gravely wounded by snap-traps.

Note: as DrugMonkey and Laura point out in comments, I goofed here. Mice are indeed covered species. From Guide for the Care and Use of Laboratory Animals.:

In this Guide, laboratory animals include any vertebrate animal (e.g., traditional laboratory animals, farm animals, wildlife, and aquatic animals) used in research, teaching, or testing.

Mice, as vertebrates, are covered. (Edited to add: DrugMonkey provides regulatory chapter and verse.)

And no matter the strength of the regulations, how well or poorly they are enforced is a separate issue. To some extent, enforcement is a local issue that will depend on the efforts of the IACUC. Enforcement will also depend on the priorities and resources of federal agencies like the USDA. Good enforcement of prevailing regulations is a good way to ensure that they’re taken seriously. But poor enforcement doesn’t prima facie mean that the prevailing regulations are too weak.

I wonder if science would have found a cure for my leukemia by now if they weren’t sidetracked by misleading animal tests. I wonder if the chemo that I took for breast cancer would have been safer it hadn’t been tested in species that are so unlike our own.

The truth is that using animals to develop and test drugs is a system that doesn’t work very well. It’s an old paradigm, one that is fortunately beginning to change, however slowly. A growing number of scientists are developing some exciting (and more effective) non-animal alternatives.

It’s true that a mouse is not exactly like a human, so treatments that prove extremely effective in mice may not be effective in humans. However, for most of the questions we would like biomedical science to answer, we are not at a point where we could just substitute computer models for animals — you can’t build a good computer model of a phenomenon you don’t understand fully, and we cannot work out all the mysteries of physiology, whether in humans or in mice, from first principles. Since Chaitowitz doesn’t really enumerate the “non-animal alternatives” she mentions, it’s hard to know what else she has in mind.

Of course, the best fit from experiment to human treatment would come from experimenting on humans. However, biomedical experiments with human subjects cannot be conducted unless appropriate studies in animals have been performed first. This is the current state of regulations in force as far as human trials go, and it’s not clear that the public wants to drop animal experimentation in favor of becoming guinea pigs themselves. Indeed, given Chaitowitz’s anger at the medical treatments she received that didn’t work as well as had been hoped, I get the feeling that not even she would cheerfully embrace being an experimental subject. I daresay that patients without a commitment to the rights of mice would be even less enthusiastic about removing the preliminary animal studies.

If you wonder how I can justify taking the drugs, the truth is that like all living beings (“lab animals” included) I desperately want to live. And because of government regulations, I don’t have a choice.

The current drug approval system doesn’t yet acknowledge the superiority of human-focused, nonanimal research methods (such as microdosing) and all pharmaceutical companies must use animals to get their drugs approved. Hopefully, this situation will soon change.

In fact, as discussed above, Chaitowitz did have a choice — to opt out of these treatments. As it happened, her desire to avoid treatments tested on animals was in conflict with her desire to live, and she went with the desire that was stronger.

How could this conflict have been avoided? Presumably, if there were drugs that were never tested on animals but only on humans. However, to use these with a clear conscience, Chaitowitz would have to be able to accept the suffering of humans in the experiments required to develop these treatments. In the absence of the preliminary testing in animals, experimenters might have much less information to start with, and the harm to human subjects might be much more extreme.

But this is a choice that Chaitowitz thinks we should have?

If the chemo drugs I’m trying now don’t work, I do have one last option. I could try a Phase One trial. That’s when a drug looks promising in animals and is first tested in humans. My doctor started to tell me why so many participants die in Phase One trials — but it turned out I already knew the answer. Drugs that work in animals, he explained, usually don’t work in humans.

This claim shows a fundamental confusion about what Phase I drug trials are for. Such trials are meant to establish what kind of dose can be safely administered and tolerated, to uncover side effects, and to assess the pharmacokinetics and pharmacodynamics of the drug. There is not any expectation that a human subject in a Phase I trial will receive a direct benefit from the treatment being administered. Generally, if it is possible, Phase I trials will be conducted on a relatively small group of healthy volunteers. However, Phase I trials may also enroll patients with end-stage diseases for whom the available treatment options have not been successful. This bears repeating: enrollment in a Phase I drug trial does not constitute treatment. Many participants in Phase I trials die because they are in the last stages of a terminal illness.

Cancer is no one’s idea of a good time, and coming to grips with our own mortality is on the verge of impossible. Undoubtedly, our desire to overcome disease and to avert death (at least until we’ve done most of the things we wanted to do) is a strong motivator to many of our medical advances. But given that our biomedical knowledge depends on data drawn from actually functioning whole organisms, getting the data makes some amount of suffering unavoidable. And given that most of the humans with whom Chaitowitz shares a government and regulatory environment seem to feel that there’s a morally relevant line between humans and non-human animals, while some of the suffering on the path to cures will be human suffering, animal studies will be an integral part of the research, reducing the amount of human suffering both in the research and in the treatment of patients in the world.

Comments

  1. #1 S. Rivlin
    March 5, 2009

    Janet,

    This is a well-written response, not only to Ms. Chaitowitz’s article, which is, unfortunatelty, based on much ignorance of the scientific method, but to all those in her camp who do benefit daily from the great medical research advancements made over the years through the use of animals.

    The majority of those who associated with the animal rights organizations are hypocrites who would never give up any of the benefits that these medical advancements offer. Rather than resorting to terroristic threats and attacks on scientists who use animals in their research, these hypocrites should decline to receive any medical treatment and procedures that were developed with the help of animal research. Only then I would have some respect for cause.

  2. #2 DrugMonkey
    March 5, 2009

    In your response to the allegation that mice are excluded from protection, I think you failed to convey that this assertion is utterly false. It is not a matter of comparing with what people do for vermin control in the house. The assertion itself is false.

  3. #3 Laura
    March 5, 2009

    I’m not sure about mice having no protection. Every lab I’ve ever worked for that used mice has had to submit an IACUC protocol detailing the ways in which we have designed our experiments to use as few mice as possible, minimizing the stress and discomfort the mice experience during our work, and replacing in vivo mouse experiments with in vitro systems whenever we can. Teams of crack veterinarians are on hand to monitor the health and safety of our mice, and we are swiftly notified if any mice became sick or injured (usually from fighting with each other — the most disturbing mouse injuries I’ve ever witnessed were all mouse-inflicted, not human-inflicted). In one case, a researcher’s lab at a former institution was banned from further use of animals when members of the IACUC determined that she’d been using mice in a manner that was, while not inherently inhumane, not specifically covered by her submitted protocol. They take mice very seriously.

    While the Animal Welfare Act may go back and forth on its coverage of common laboratory animals (it seems that mice and rats have been officially covered by it in the past, if my brief Google-based research is correct?), most individual institutions set their own IACUC policies that most definitely do cover mice.

  4. #4 S. Rivlin
    March 5, 2009

    It is time that someone from PETA or PCRM stands for mice’s right to fight and kill each other if they so choose, without IACUC sticking their noses in this mice business. ;)

  5. #5 Paul Browne
    March 6, 2009

    Well, what else can you expect from the former communications director of PCRM, an organization that is up to it’s waist in woo and can hardly be expected to take a realistic stance on cancer drugs. Just look at this piece Orac wrote the other day
    http://scienceblogs.com/insolence/2009/03/dr_dean_ornish_turn_away_from_the_dark_s.php#commentsArea

    Sometimes I wish we could lock PCRM in a room with the equally misleading Association of American Physicians and Surgeons*, throw in a bunch of knives and leave them to get on with it while the rest of us get on with developing new treatments and vaccines and building a medical system fit for the 21st century.

    * http://scienceblogs.com/insolence/2008/11/oh_no_barack_obamas_hypnotizing_us_all_t.php

  6. #6 scicurious
    March 6, 2009

    I would love to see the human volunteers that would stand up as the placebo control for a new chemotherapy study. Esp if it was double-blind. Let alone NEW drug studies, where we’re not sure of dose. Not only that, humans are almost always on other drugs, which may have interactions, so telling the effect of your new drug would be a lot harder. Experimenting on humans alone just isn’t feasible at this point, and I don’t know if it ever will be. I think we are more likely to develop an accurate computer model first, and that is many, many years into the future.

  7. #7 S. Rivlin
    March 6, 2009

    scicurious,

    Endless animal experiments must still be performed before a computer model could be developed, a prospect that none of these organizations supports. Of course, any computer model will also have to include the behavioral aspects of the cooks who comprise these organizations, a task that could be beyond reach.

  8. #8 Wanda
    March 6, 2009

    There is no way the drugs tested on animals could be accurate. How do we know what drug is affecting them when the same animal is used in numerous tests and experiments. Common sense tells me the stress and accidents in labs would affect the results in research.
    I have lost my confidence in animal research. I do not accept any of the new drugs on the market, they are too expensive.
    The argument that we wouldn’t know this or that if we didn’t use animals. How can we know something else works if only use animals in research, and never try any thing else.Scientist never are too willing to accept anything new. How many decades did they insist animals couldn’t feel pain and suffering? At one time they believed newborn babies couldn’t feel pain, this was their belief until the 1970′s.
    I never have been one to believe everything I hear or read.

  9. #9 S. Rivlin
    March 6, 2009

    “How do we know what drug is affecting them when the same animal is used in numerous tests and experiments.”

    Wanda, unless drug interaction is being studied, no animal is being used in more than one drug study.

    “Scientist never are too willing to accept anything new.”

    Once the “new” has been tested and verified, scientists accept it completely. Demanding that the “new” is duplicated or even triplicated by other scientists is a precondition for science to exist and progress. It is alternative medicine and voodoo that cannot be tested or verified and which ignorants are more than happy to try. Don’t forget to pray before rejecting the next new drug that could fight AIDS or the Bird Flu, heart disease or arthritis, stroke or diabetes.

  10. #10 RebeccaF
    March 6, 2009

    “Scientist never are too willing to accept anything new.”

    “At one time they believed newborn babies couldn’t feel pain, this was their belief until the 1970′s.”

    So, their opinions changed? As in, they were willing to accept something new?

    Oh, the irony of contradicting your own statement two sentences later.

  11. #11 Paul Browne
    March 7, 2009

    “Endless animal experiments must still be performed before a computer model could be developed,”

    A good example of this is the Blue Brain project, a highly ambitious project that aims to model the mammalian (ultimately the human) brain. They started by modelling the rat neocortical column precisely because studies performed on the rats allowed them compare the predictions made by their model with what is really happening in the NCC.

    http://bluebrain.epfl.ch/page19092.html
    http://bluebrain.epfl.ch/page18924.html#4

  12. #12 Fia
    March 8, 2009

    This is a misconception. In science, we use models to test our hypothesis. That means, we have prior knowledge about for instance the mouse physiology, and how this in most cases translates into human physiology. Experiments that are made on the mouse model are well thought through (because we do not want to harm animals for nonsense) and only undertaken if we have reason to believe that the results will add valuable knowledge. In some cases, yes, it will turn out that what works in mice won’t work in humans, however, that also (!) adds knowledge because it can prevent useless experiments or guides us modify experiments accordingly in the future.

    Animal experimentation is, next to many other misunderstandings between science and the general public, one of the cases that shows the need of schools teaching science philosophy better, so that people can understand better why we seemingly cruel things are done to mice. Because the idea of using animals as models is apparently something Wanda or Mrs Chaitowitz have never learned or understood properly.

  13. #13 padraig
    March 11, 2009

    Wanda, most folks here are taking issue with your comments but I want to make sure to recognize some good thoughts of yours:

    “Scientist never are too willing to accept anything new.”

    I think if you had worded this as “Scientists do not always welcome change” you would have gotten a lot of agreement. If workable animal testing alternatives are developed, I expect they’ll encounter some resistance until they are proven. And not all scientists are willing to dip their toes in the water first.

    “I never have been one to believe everything I hear or read.”

    Nor should you. But please apply that to every source. In particular apply it to any advocate group, whether it be PETA or the Center for Consumer Freedom. Everybody’s got an ax to grind. Good luck finding the balance between critical and cynical.

  14. #14 V Jones
    March 12, 2009

    on a purely academic note- even if animal rights people abstain entirely from animal-tested medicines, they still benefit from “herd immunity” – because so many other people are being treated- e.g. for infectious diseases with drugs tested on animals – and are immunised (with vaccines developped in/tested on animals). So whatever they do, they will still reap the benefits of animal testing.

  15. #15 AR Hogan
    May 5, 2009

    As someone who has partaken in an extensive eight-month-long double-blind clinical trial at NIH, worked as a science journalist (covering space, environment, health, and history, among other topics), fully understands the scientific method and process and loves good science, has earned an M.A. and is finishing a PhD related to science journalism history at UMCP, and also knew the late writer and environmental-animal-rights-women’s-rights-peace etc. activist Ms. Simon Chaitowitz for more than 11 years, I wish to weigh in here.

    Very unfortunately, she died from leukemia complications in DC on Sunday 19 April 2009 CE. Further disclosure: I happen to be pro-animal rights and pro-vegan–I only wish that I had been since birth. But I do not state or write ever that nonhuman animal experiments NEVER have produced ANY useful results, as that would be intellectually dishonest, much as I wish it were true. What I can and do state and write is that very little reliable and applicable data has been garnered from nonhuman animal experiments that could not have been obtained elsewise. Nonhuman animal experiments regularly produce false positives (e.g., thalidomide) and false negatives (e.g., aspirin)–and do so at a steep ethical price. Please check out the books and articles by Ray Greek, MD, and Murry J. Cohen, MD, among others.

    We also collectively need to strongly emphasize true prevention (which some confuse and conflate with early detection). People who consume tobacco, alcohol, meat, dairy, eggs, and so on significantly and needlessly increase their risk factors for a wide and deep assortment of diseases.

    Politicians and bureaucrats, with few refreshing exceptions, do not want to be like the boy in the tale “The Emperor’s New Clothes” and fully take on Big Tobacco, Big Booze, Big Meat, and similar others led by those who apparently lack consciences and mainly like making lots of profit money off human and nonhuman misery and death. Yes, some people with genetic good luck may seem to elude the usual consequences–but maybe those occasional smoking, drinking, meat-eating centenarians would have lived even much longer as nonsmoking, nondrinking, vegans.

    I am desperately hopeful that best-practice science will soon indefinitely extend, with good quality, human lifetimes–especially our brains, our most important parts by far. I would not wish the six-year, three-bout breast cancer and leukemia fight Ms. Chaitowitz endured on even the most un-remorseful vivisector. The 100-plus illnesses we collectively call cancer are utterly horrible, as are others, and I would like to see them ASAP go the way of smallpox, and soon perhaps polio, malaria, and TB.

    In 2011, the USA will mark the 40th anniversary of the Nixon-declared War on Cancer. If only we had focused on non-animal approaches (as is catching on especially in Europe), acted decisively against known cancer causes (e.g., in 2009–45 years after USSG Dr. Luther Terry’s smoking report, itself a latecomer [please look up King James anti-tobacco pamphlet from four centuries ago]–we still lack a federal tobacco ban, or even a national USA secondhand smoke ban, and animal products continue being dumped in schools), and channeled much more money and brainpower into anti-cancer efforts (rather than wasting vast sums and smart minds on military endeavors, for example), perhaps Ms. Chaitowitz and so many other wonderful people would still be with us. She took on some of the blame for her situation–she very sadly did not become vegetarian and then vegan until well into adulthood, and she very unwisely smoked tobacco cigarettes for several years as a young woman. However, some Web posters here alas have seemed to question her 2009 intelligence and honesty, and I can certainly vouch for both. She was an unusually articulate, informed, and caring individual.

    As for me, I love science and I love compassion–and I do not consider those stances in any real conflict.–AR Hogan

  16. #16 AR Hogan
    May 5, 2009

    PS: My own years-past experience as a reporter re IACUCs was that pro-animal-experimenters dominate them, that much of what they do is shrouded in secrecy, that while they may curtail the occasional over-the-top proposed excess, they mostly approve research protocols involving nonhuman animals. Typically, a member of the local clergy or a philosophy professor may be appointed for perceived balance, but seldom do such persons possess the detailed knowledge, or frankly the motivation, to strongly argue the opposing case. They remind me of juries in death penalty cases where no one against the death penalty (which should be abolished anyway) is allowed to be empaneled. That not only precludes someone against the death penalty from being on a jury, but those very people tend to be more skeptical of prosecutors, and thus resulting juries often wind up being very prosecution-and-police-friendly. With all due respect, IACUCs seem to work in a similar pattern, unless they have delta-ed markedly in recent years.

  17. #17 Lee
    May 14, 2009

    Fuck you bitch. I hope someone tests on you. It is people like you that allow animals to suffer like they do. You are going to go to hell for your beliefs. All out of the greed that you have been brainwashed into. The woman that wrote this article is right and you have no reason to pick her apart because she cares about living things. Animals deserve to be treated as equally as humans.