White Coat Underground

Medical nihilism

Human medicine advances in the way much of science does. People make systematic observations, form plausible hypotheses, and collect data. One of the more important questions in medicine is how people are affected by certain exposures. When that exposure is a medicine, we prefer data from double-blinded, randomized controlled trials. Other types of exposures (such as cigarette smoke) are less amenable to RCTs and we must rely on case-control, cohort, and other studies that examine correlation.

But before we can run RCTs on human subjects we need more than just a plausible hypothesis; we need to know that the medicine appears to be safe and effective in a biological system. Usually, we use animal models, with the choice of species being dependent on the study design and the biology of the drug and the disease. By choosing this approach, we have made a value judgment: human health is important enough to allow us to test drugs and procedures on non-human animals. Our alternatives are limited: either we test drugs first on humans, or we don’t develop new drugs.

So I was watching my local PBS station yesterday (perhaps for the last time) and I came upon Dr. Neal Barnard shilling some book or other on curing diabetes. That pissed me off enough to go to his website and check him out, but before I got into the other details I see that he founded something called the Physicians Committee for Responsible Medicine (PCRM). I vaguely recall hearing about this group during medical school. There were some students who joined as advocates of “ethical animal research”, apparently unaware that ethics are already a big part of animal work. Since then, I haven’t thought about the group.

Until now.

Any group founded by a doctor promoting questionable practices might itself turn out to be a bit questionable. The site looks just fine, and Dr. Barnard brings up many seemingly reasonable points:

PCRM advocates higher ethical standards in conducting human research and providing access to medical treatment.

Ethical standards are pretty high already, so I was curious what he had in mind. He starts off talking about previous work that was unethically, such as the Tuskegee Syphilis study. That’s fine, but most of us already know this stuff. He brings it home with this:

A more widespread ethical problem, although one that has not yet received much attention, is raised by new pharmaceuticals. All new drugs are tested on human volunteers. There is, of course, no way that subjects can be fully apprised of the risks in advance, because that is what the tests are conducted to find out.

Here’s how this works. Phase I trials of new drugs are the first level of human study and are designed to test toxicity and the pharmacologic characteristics of new drugs. This is typically done with small groups. If it seems likely that the drug is safe, phase II trials are run as a basic test of efficacy. If these go well, large phase III trials are run to see how the drug acts in the population in question. At this point rarer adverse events may show up, but really rare adverse events might not show up until millions of people are exposed and identified in post-marketing surveillance.

Because we want to develop drugs and devices to help humans, and because we don’t love the ethical implications of jumping straight into human trials, we usually run animal models before Phase I trials.  What Barnard and the PCRM are asking for in demanding “higher ethical standards” is unclear, because after stating his concern for human subjects he states:

Human beings, of course, are not the only potential victims of unethical research practices. Given the emerging history of abuses and secrecy in human experimentation, the idea that animals–the 20 million chimpanzees, cats, dogs, and rabbits used every year in laboratories–will somehow be better treated is unconvincing, to say the least. Whether the subjects are humans or animals, any assumption that experiments are always necessary, always carefully monitored, and always ethical is a fiction.

Aside from the obvious Nivanna fallacy here (“since things aren’t perfect they are entirely bad”), his argument boils down to a horrific nihilism.  He is arguing against animal and human trials, which means we cannot develop new drugs and devices.  What, then, can we do about human health and disease?  Apparently he thinks everything can be fixed by a vegan diet, but I’m sure it’s more complicated than that.  Still, I shudder to think of a world where people like Barnard use their muddled, disingenuous reasoning to halt vital research.

Comments

  1. #1 Pascale
    December 10, 2009

    Animal research benefits animals as well as people. If we want to improve the health of all living beings, animal research is essential.
    Some of the statements on PCRM use very selective references, ignoring the ones that do not fit their agenda. Your last sentence sums it up well; shuddering is the appropriate response.

  2. #2 Leslie
    December 10, 2009

    Three things came to my mind when I read your blog post:

    a) It’s going to be flipping AWESOME when we can generate human skin tissue, cow muscle tissue, etc. in the lab and do at least some tests and make at least some meat without harming entire individuals.

    b) Until then, we gotta have both preclinical and clinical trials for both human and veterinary medicine.

    c) Did you hear about how sometimes gorillas get veterinary treatment based on human “testing” (OK, knowledge that the non-veterinary members of the doctor teams learned from treating their human patients who already had what the gorilla now has)?

    http://blogs.wsj.com/health/2007/09/20/chicago-gorilla-get-any-kind-of-care-she-wants/

    http://www.seattlepi.com/local/346922_gorilla11.html

  3. #3 Russell
    December 10, 2009

    So why is it that so many physicians, when prescribing for some problem, jump to the latest drug, rather than one that has decades of use behind it? Yeah, I understand the new drug might not have some infrequent side effect. But that side effect is well-known, easily noticed, and it’s easy to switch if necessary. And who knows what not-yet-known side effects the new drug has?

    Given a choice, I’d rather have a drug that has been used for decades on tens of millions of patients, and which is therefore less likely to surprise with a not-yet-known effect. And given how drugs are priced, it will be cheaper to boot.

  4. #4 bob koepp
    December 10, 2009

    It’s simply bogus of PCRM to suggest that there’s something ethically questionable about research when there’s “no way that subjects can be fully apprised of the risks in advance, because that is what the tests are conducted to find out.” What’s necessary is simple: (i) clearly describe the risks that we do know about, (ii) make sure potential subjects understand that there might well be additional risks that we still haven’t learned about, and (iii) monitor subjects very closely for unexpected adverse events. Not engaging in research because of unknown risks would be a lot more ethically problematic than confronting uncertainties with our eyes and minds wide open.

  5. #5 PalMD
    December 10, 2009

    So why is it that so many physicians, when prescribing for some problem, jump to the latest drug, rather than one that has decades of use behind it?

    This begs the question. I have no way of knowing if this premise is in fact true. Of course “so many” could mean 23, so who knows…

  6. #6 Markk
    December 10, 2009

    “So why is it that so many physicians, when prescribing for some problem, jump to the latest drug”

    Huh? Having looked at what is prescribed as a Data Warehouse guy, I would say that statement is false. Physicians normally prescribe the same old stuff over and over and over again and almost never change. What doctors are these that jump to new drugs in preference to old?

  7. #7 Jon H
    December 10, 2009

    PBS is dead to me. If it’s not crap like this, it’s crap like a weekend full of “Celtic Women” and Andre Rieu. Blech.

  8. #8 Biochem Belle
    December 10, 2009

    There’s also the complete muddling of facts. Just from the excerpt you posted:

    the 20 million chimpanzees, cats, dogs, and rabbits used every year in laboratories

    This is completely wrong. The 20 million estimate is actually for all animals used in research-and mice and rats account for more than 95% of that number. There are some great stats and comparisons to the number of animals used for food in the US at http://www.speakingofresearch.com

  9. #9 Calli Arcale
    December 10, 2009

    Doctors do sometimes recommend the latest whiz-bang drugs instead of the old, tried-and-true ones. This is because they are painfully aware of the problems with the tried-and-true ones. Say there’s a drug that’s cheap, plentiful, and comes with tons of long-term data because it’s been around for 40 years. One uncommon but recognized side effect is splitting headaches (for instance). Patient A gets debilitating headaches while on the drug. Now say there’s a brand-new alternative which promises fewer side effects. The doctor’s going to try that, even though there’s less safety data available, because the traditional drug is making the patient’s life miserable.

    It happens for less dramatic side effects too, because doctors really don’t want to be making their patients hurt. The bottom line, though, is that it’s not always unreasonable to try new stuff.

  10. #10 Julius
    December 11, 2009

    “Apparently he thinks everything can be fixed by a vegan diet”

    Well, who’d have guessed? Although amusingly, wouldn’t that make his own job obsolete… I mean, what do I need a doctor for, even a highly “ethical” (snigger) one, if the answer to any question is just “go vegan”?

  11. #11 BB
    December 11, 2009

    Glad you found out the truth behind PCRM and “Dr” Nean Barnard.
    Want more info, visit http://www.animalscam.com (I have no affiliation with the site).

  12. #12 Nomen Nescio
    December 11, 2009

    The 20 million estimate is actually for all animals used in research-and mice and rats account for more than 95% of that number.

    what does “used in research” mean in this statistic, anyway? is a lab animal only “used” if it has to be killed afterwards, or are these 20 million animals ones that participate in some study and might go on to participate in another?

  13. #13 ducks-like-a-quack
    December 11, 2009

    Is a vegan diet effective for treating type 2 diabetes? An epistolary investigation, The Cincinnati Beacon, 12/11/09

    The Physicians Committee for Responsible Medicine (PCRM) is a Washington DC nonprofit which, according to its website, advocates “compassionate and effective medical practice, research, and health promotion.” We first learned of PCRM because of Cincinnatian Dr. Henry Heimlich. He’s a founding board member of the organization, which will be presenting the “Henry J. Heimlich, M.D. Award for Innovative Medicine” this April in Malibu.

    The following correspondence – slightly edited for clarity – was prompted by a widely-syndicated November 25, 2009 article by Mike DeDoncker of the Rockford (IL) Register Star entitled, “Diabetes Expert: Try Vegetarian Lifestyle.” DeDoncker’s story describes a PCRM diabetes treatment program “sponsored by the University of Illinois College of Medicine at Rockford and Vegetarians in Motion.”

    (Read on….)

  14. #14 katydid13
    December 11, 2009

    Years and years, I got offered a job interview PCRM and it was the strangest experience of my life. It was a blind ad that didn’t say who was hiring, just they were looking for someone with entry level policy skills and a knowledge of vegetarian diets. Then I got to the interview and discovered they were you know crazy.

  15. #15 k
    December 12, 2009

    “So why is it that so many physicians,
    when prescribing for some problem, jump
    to the latest drug”

    Huh? Having looked at what is prescribed
    as a Data Warehouse guy, I would say that
    statement is false. Physicians normally
    prescribe the same old stuff over and
    over and over again and almost never
    change. What doctors are these that jump
    to new drugs in preference to old?

    Do you see pulmonologists prescribing
    theophylline any more, now that inhaled
    steroids or inhaled steroid/LABD combo
    products are gold standard for asthma
    control? How about shrinks writing for
    tricyclic antidepressants, MAOIs, or
    older anti-seizure meds when there are
    new drugs (some of which have gone generic)
    that work so much better? (I’ve gone
    through many rounds of Rx roulette until the most effective
    combination with the fewest side effects
    is found. I dissuade my shrink from
    giving me most new stuff, after
    anaphylaxis from a couple of rounds
    of the Next Big Thing.)

  16. #16 ursa major
    December 15, 2009

    a) It’s going to be flipping AWESOME when we can generate human skin tissue, cow muscle tissue, etc. in the lab and do at least some tests and make at least some meat without harming entire individuals.

    This does not eliminate the need to study whole living organisms. So what if the study drug is non-toxic to isolated skin cells when the liver metabolizes the drug into 4r different toxins. Or what if the parent drug is worthless but only becomes effective after the liver has processed it?

  17. #17 DPSisler
    December 16, 2009

    @K, my doctor proscribes theophyline for me because it works best for my asthma. Therefore, whatever your point is, it is wrong.

  18. #18 kd
    December 18, 2009

    A few years ago, I saw Barnard on my local PBS station claiming that a vegan diet is the only cure for any type of arthritis. Well, I’m a vegan and I still have arthritis. Barnard is a kook.

  19. #19 Leslie
    December 19, 2009

    “‘a) It’s going to be flipping AWESOME when we can generate human skin tissue, cow muscle tissue, etc. in the lab and do at least some tests and make at least some meat without harming entire individuals.’

    “This does not eliminate the need to study whole living organisms. So what if the study drug is non-toxic to isolated skin cells when the liver metabolizes the drug into 4r different toxins. Or what if the parent drug is worthless but only becomes effective after the liver has processed it?”

    Good point, and that’s why I said “at least some tests” instead of “all tests” or just “tests”