Anti-Vaccine Activists and Conservative Christians vs HPV Vaccination

I’ve written before about the link between religion and CAM, both the philosophical link and the political alliance. However, I could not have imagined a clearer and more fascinating example of this than the article recently sent to me by a solidly skeptical and science-based medicine provider, Gardasil Researcher Drops A Bombshell — Harper: Controversial Drug Will Do Little To Reduce Cervical Cancer Rates. The friend who sent the article was concerned about the safety of the vaccine for her granddaughter based on the information it provides, and she wanted my input.

On the surface, the article reads like a science-journalism bombshell indeed. Apparently a lead researcher involved in the development of Merck’s human papilloma virus (HPV) vaccine Gardasil claims that the vaccine is essentially useless in preventing cervical cancer, and has not been adequately tested in girls under 15 despite its widespread use in this group. However, a bit of research into the individuals and organizations involved in this story yields a Byzantine web of connections between the Christian anti-abortion, anti-birth control lobby and the anti-vaccine community worthy of a Dan Brown novel.

The researcher referred to, Dr. Diane Harper, was involved in clinical trials examining the efficacy of the Gardasil vaccine and has written numerous scientific publications on the efficacy of HPV vaccine. However, she also has a long history of comments critical of HPV vaccines. It is unclear whether Dr. Harper is genuinely concerned that these vaccines may turn out to do more harm than good, or if her appropriate caution about overselling the benefits or downplaying the potential risks is simply being used by the anti-vaccine movement to suggest that even a key figure in the development of these vaccines believes they are useless and unsafe. The latter seems more likely given Dr. Harper’s extensive research and publications in the area of HPV vaccination, but it’s hard to say.

It is interesting that the event at which Dr. Harper allegedly dropped her “bombshell” was the 4th International Public Conference on Vaccination. This is a faux scientific meeting organized by the National Vaccine Information Center (NIVC). The NIVC is to the anti-vaccine movement as the Discovery Institute is to the Intelligent Design movement. It is a well-organized and well-funded group that strives to give the patina of scientific legitimacy to unfounded and irrational opposition to vaccination. The speakers at this meeting included Andrew Wakefield, the father of the vaccines-cause-autism myth, Richard Pitcairn, the founding father of veterinary homeopathy and the leading veterinary anti-vaccine advocate, and a long list of others with a decidedly hostile attitudes towards vaccination. Again, it is unclear whether Dr. Harper felt that speaking at such an event was a chance to argue for vaccination against HPV in “hostile territory” (as the article contends) and she simply did so badly, or if she chose to speak in a forum where she knew any criticism of any vaccine would be warmly received.

The gist of Dr. Harpers comments as reported in the article is that HPV rarely leads to cervical cancer and that current detection and treatment regimes are so effective that the vaccine adds little to the fight against cervical cancer. She was also quoted as say “The rate of serious adverse events is greater than the incidence rate of cervical cancer.” If true, this would indeed be a strong case against vaccination for HPV.

I do not have adequate information to say with certainty whether this case is in fact as strong as the article suggests, but I am skeptical. The CDC presents information that directly contradicts some of the statements attributed to Dr. Harper and gives a strong recommendation in favor of vaccination, so it would surprise me if there was in fact such an obvious slam dunk argument against the HPV vaccine. In any case, I’m hoping the folks over at Science Based Medicine will offer a fact-based perspective on this soon.

The article is also questionable in following the common misleading strategy of citing large numbers of adverse events reported following HPV vaccinations without acknowledging that the overwhelming majority of these are never demonstrated to be caused by the vaccine. It even goes so far as to refer to the case of Natalie Morton, a young girl in England who died shortly after receiving an HPV vaccine. Despite the misleading initial media reports, it is clear that her death was due to a malignant tumor and had nothing to do with the vaccine. The author does not bother to mention this fact in her article, which raises further questions about the accuracy and objectivity of her reporting.

The plot thickens, then, when we look into the background of the journalist who authored the article, Susan Brinkmann. Ms. Brinkmann is a member of the Secular Order of the Discalced Carmelites, which is a group of lay Catholics who are affiliated with and adhere to many of the rules and practices of the nuns and friars who are primary members of the order. Interestingly, she is also the author of The Kinsey Corruption, a book which argues that Alfred Kinsey was a “committed atheist…[who] was determined to undermine the traditional moral climate of America and pave the way for the widespread acceptance of all kinds of perversity, including pedophilia and bestiality,” and which blames the current state of moral “decay” in American on the loss of “traditional” values regarding sexuality. Ms. Brinkman has also written extensively opposing abortion, homosexuality and birth control. One does have to wonder, then, if the apparently damning case against HPV vaccination presented in her article is objective and truthful or perhaps influenced by a concern sometimes expressed among conservative Christians that vaccination might encourage sexual activity among adolescent girls.

Another figure in the article, who is quoted three times emphasizing that Dr. Harper’s talk made the case that the HPV vaccine is unnecessary, is Joan Robinson of the Population Research Institute. This organization is a coalition of pro-life groups founded by a Catholic priest with the goal to, as their mission statement says:

“Debunk the myth of overpopulation, which cheapens human life and paves the way for abusive population control programs

Expose the relentless promotion of abortion, abortifacient contraception, and chemical and surgical sterilization in misleadingly labeled “population stabilization,” “family planning,” and “reproductive health” programs.

Defund these programs by exposing the coercion, deception, and racism inherent in them.

Promote pro-natal and pro-family attitudes, laws, and policies worldwide.”

Once again, the damning case against HPV vaccination is made by someone who (coincidently?) opposes birth control, abortion, and other medical interventions to reduce the risks of sexual activity. Hmmm….

This article has the potential to raise troubling questions about the safety and efficacy of HPV vaccination in the minds of reasonable people. However, the case made by the author begins to unravel with relatively little probing into the facts presented and the agendas of the individuals and organizations involved. Such research makes it clear that the anti-vaccine movement, which opposes HPV vaccination for all the usual irrational reasons and despite unequivocal evidence that they are wrong, and conservative Christians, who appear to oppose anything that might make having sex safer, have banded together to spread fear and misinformation about HPV vaccination.

As frightening an alliance as this might be, I fear it cannot last. Though research shows CAM providers to be somewhat more religious in temperament that some scientific medicine providers, they tend to be less committed to a specific religion and more inclined towards vague New Age varieties of spirituality. Among Ms. Brinkman’s writings,  however, is the book Learn to Discern: Is it Christian or New Age which warns against the dangerous influence and likely demonic nature of some New age practices. I suspect the opposition to HPV vaccination will be a short-lived marriage of convenience between conservative Catholics and the pro-CAM, anti-vaccine fringe.

Dr. Harper’s role in the story is less clear. Given her credentials as a researcher into HPV and a proponent in many cases of HPV vaccination, I am inclined to take her concerns more seriously than those of NVIC or the Catholic Church. However, her choice to speak at the NVIC meeting, and her comments if they are represented accurately, diminishes her credibility. I suspect there are even more layers of intrigue beneath the surface that I have been unable to penetrate.

In any case, this article, and the unraveling of some of the personalities and hidden agendas behind it, is an excellent example of the unreliability of so much “science journalism.” It is understandable, and sad, that people unable to look deeper into such media reports will be mislead by them, and the resultant fear and confusion can lead to poor decision making. The anti-vaccine movement relies on spreading such fear and confusion, and they are skilled at doing so. Those of us committed to giving people truthful and objective information to use in making healthcare decisions have an obligation to reveal the reality behind the smoke and mirrors of propaganda like Ms. Brinkman’s article, and to encourage and support the work of real science journalists.

Posted in Vaccines | 8 Comments

Protest Government Protection of Unproven and Ineffective Medicine

The Center for Inquiry, a pro-science and secularism think tank and lobby,  which previously issued a white paper about the attempts of Tom Harkin and others to insert protection for non evidence-based CAM in healthcare reform legislation, has continued to track these attempts through the legislative process. Unfortunately, as a vote appears to be drawing near on bills in both houses, the woo-protection elements have only gotten stronger. Recent additions to the legislation specifically protect religious based medical intervention, such as Christian Science faith healing. The Center for Inquiry has put together a simple tool to facilitate contacting your legislators to protest this government protection of unproven and bogus therapies and support for religious belief over science in government funded and protected healthcare.

We cannot allow the health care reform process to mandate the spending of government and insurance money on faith healing and unproven CAM. Doing so will only make real, life-saving care more expensive and less available. Please take the time to participate in the political process and let your representatives know where you stand.

Posted in Law, Regulation, and Politics | Leave a comment

Animal Hospice — We Need It, and We Need to Do It Right

Over the last several decades, attitudes towards pets and their role in our households have change dramatically, and in my opinion for the better. Many pet owners see their animal companions as family members rather than objects of utility and entertainment. Pets are brought to the veterinarian with goals and expectations more like those of a parent bringing their child to the pediatrician than of an owner bringing a broken car to the mechanic.

This change in attitude has supported progress in the quality of veterinary care. Better attention to pain control and quality of life, more and better therapies, and of course the expectation that veterinarians will follow the principles of evidence-based medicine that are the standard of care in the human medical field are all positive developments in the profession made possible by clients’ growing desire to have the best care for their animal companions.

And as pet care has improved and our pets have come to live longer, we are more frequently confronted with the issues associated with caring for geriatric patients. Older pets will often have complex and multifaceted medical problems. They may suffer from chronic diseases, including degenerative processes such as osteoarthritis and loss of hearing, vision, mobility, continence, appetite, weight, and even cognitive and behavioral functions. And ultimately our pets will come to the end of their lives, and an important part of our work as veterinarians is helping our patients and their owners through this part of the life cycle.

Because pets are more and more members of the family, owners may not simply wish to euthanize at the first sign of serious disease. Veterinarians can and should be able to support their clients through the process of accepting and grieving for the impending loss of a pet while still strongly advocating for the interests of their patients. Unfortunately, training and resources to help veterinarians do this effectively are scarce, and vets may not be aware that there is more they can offer besides steroids and euthanasia.

In human medicine, the hospice model has become the dominant approach to end-of-life care. While there are many different specific forms hospice care can take, in general the philosophy is to palliate the clinical symptoms of the dying person and also support the patient and the family through the logistical, psychological, and often spiritual aspects of the dying process.

The emergence of hospice represents a salutary change in cultural attitudes which more and more accept that death is part of the life cycle and need not be denied or hidden away. Dying people and their families deserve physical and psychological comfort, and if medical and allied health care personnel are accepting and comfortable with the dying process they can better provide appropriate care.

Of course, in general euthanasia is not an option for people at the end of their lives, and it is a common practice in veterinary medicine, and widely accepted as appropriate medically and morally. So the hospice model has been slow to gain acceptance in the veterinary medical community. However, there are veterinarians and others working to bring this practice to our pets. I think many of the attitudes and practices of hospice are desperately needed in the veterinary field. Like the rest of our culture, I think veterinary medicine would benefit tremendously from a more accepting attitude towards death and dying, and I think our patients and clients can and should receive better care and comfort from us even when we can no longer substantively influence severe disease processes.

However, I am also concerned that some of the people involved in this movement may be bringing irrational ideas and approaches to the process which may ultimately end causing rather than relieving suffering for our patients.

The International Association for Animal Hospice and Palliative Care (IAAHPC)  has recently been established, with the stated mission to promote hospice care and establish protocols and standards for such care. The organization was founded after a symposium on animal hospice held March, 2008 at the University of California Davis. The existence of differing, and sometimes incompatible philosophies regarding hospice care are hinted at on the IAAHPC website:

“IAAHPC is committed to being an organization that is inclusive in its philosophy; it will represent different professions and differing viewpoints of animal hospice/palliative care, end of life, and death and dying.

Some in the animal hospice movement see their own views as diametrically opposed to other views. But whether we like it or not, the animals and society will be best served by focusing on our common interests and by respecting our differences.”

A little investigating of the organization’s board of directors provides some insight into these differences. A number of the members are strong advocates of CAVM practices and critical of mainstream veterinary medicine. Dr. Ella Bittel is a “holistic” veterinarian with strong CAM credentials. She practices acupuncture, chiropractic, homeopathy, Bach flower therapy, and TTOUCH and other energy therapies. She is also an active member of a number of CAVM lobbying groups and has published in the  Journal of the American Holistic Veterinary Medical Association on the topic of hospice care. In her article, she is suggests that “holistic” veterinarians are more likely to embrace the hospice process and paints a rather bleak picture of mainstream veterinarians forcing euthanasia on their clients and “disenfranchising clients from their basic right to chose[sic] what they feel is best for the animal they have cared for throughout its entire life.”

In her other writings, Dr. Bittel frequently promotes the value of CAVM therapies for relieving discomfort or preserving function when “Western” medicine has failed. As I have discussed before, most of these assertions are unproven or outright false. Dr. Bittel  also makes frequent reference to an animal’s “will to live” and “dying wishes,” which she suggests owners and caregivers can intuit through a “hunch,” “tuning in with a calm mind,” and so on. She describes poignantly her loss of her own dog, and includes as a vital facet in making care decisions her inner sense of what her pet wanted.  

I respect the energy that Dr. Bittel is putting into promoting the hospice concept, and I agree with her that there is a need for better end-of-life care for our pets. However, I reject the cliché that she puts forward  that veterinarians who describe themselves as “holistic” are in any real way truly more aware of or interested in the welfare of their patients as whole beings. “Holistic” has strayed far from its literal meaning to become merely a shibboleth indicating a faith commitment to unproven or outright bogus medical approaches, often relying heavily on vitalism and a vague New Age mélange of spiritual beliefs. Homeopathy, Bach flower therapy, and “energy medicine” offer no real relief of suffering for our patients, and they offer only the limited comfort of placebo by proxy for our clients. I have seen many patients suffering clear and obvious pain because their owners refused to see that the faith-based medicine they were using was failing, and because they had irrational fear of real medical therapies. Cognitive dissonance and other forms of denial are powerful, and we do our patients no service by helping our clients to deceive themselves that their pets are comfortable and happy when they are in fact suffering.

Pet owners desperately want to hold on to their beloved companions as long as possible. Owners and veterinarians want the pets we care for to be happy and well, and we want our efforts on their behalf to be successful. It is all too easy to project these desires onto our pets and see what we want to see. Promoting subjective, intuitive methods of divining what our pets “true” feelings and desires are, and discounting the behavioral signs available to us, as Dr. Bittel sometimes suggests, is a dangerous practice that promotes such emotional projection and the mistaking of our desires and interests for those of our animal companions.

Examples of tragic harm that can be caused by such approaches abounds in human medicine, including the fads of Facilitated Communication and Repressed Memory Therapy. I have had numerous encounters with pet psychics or “animal communicators” who claimed to speak for the inner thoughts and feelings of some of my patients. They often provide vague, reasonable statements that could apply to any animal at any time. They certainly appear to comfort clients, and I have never seen one claim to intuit something from an animal that a clients really didn’t want to hear. But I have also seen the worst of them flagrantly pander to the client’s inability to accept the inevitable loss of their pet and continue to re-assure them their companion was content and did not want to be euthanized despite obvious and awful suffering. Such irrational methods for making decisions about quality of  life, palliative care, and euthanasia are not in our pets’ best interests and have no place in veterinary hospice care.

Other members of the IAAHPC founding board besides Dr. Bittel also promote a “holistic” or CAVM-based approach to veterinary care, including Gail Pope, who is affiliate with a “Holistic Animal Retreat” which promotes homeopathy and “animal communication” as part of its services. The philosophical and epistemological perspectives of other board members isn’t readily apparent, and I suspect from the reference to “difference” quoted above that some are strongly in favor of a science-based approach to end-of–life care.

Certainly, there is no need for absolute uniformity in clinical practice related to hospice care, and the IAAHPC statement is correct that the goal of improving end-of-life veterinary care is important enough to warrant attempts to find common ground and accommodation among veterinarians with different approaches. However, if the flagship organization for the hospice movement, the group setting the standards for the profession, is ultimately dominated by faith-based medicine and  misleading vitalist philosophies, then the standards that are adopted may very well do more harm than good.

Euthanasia should certainly not be the only or first recourse in serious terminal illness, but neither should it be shunned as “unnatural” or discouraged on the basis of “intuitive” methods of quality-of-life assessment that project the owners needs and wishes onto the patients. And while homeopathy or flower essences may give the owner the comfort of imagining they are doing something to contribute to their pets’ wellbeing, they should by no means be used in lieu of truly effective therapies for control of pain, nausea, and other discomfort associated with dying. Every attempt should be made to ensure that the methods of assessing the condition of the pet and the response to palliative therapy, and the therapies that are employed, are consistent with the best evidence and most sound scientific principles possible. No one should deny our clients the comfort of  rituals and spiritual practices that they may wish to invoke when their pets are sick or dying. But just as parents cannot legally or morally deny their children the best scientific medical care available on the basis of religious or other faith-centered beliefs, so animals who are dying should not be denied adequate palliation and euthanasia on the basis of such beliefs. I believe there is much of value in the hospice approach that can and should be brought into veterinary medicine, but I also believe that to do hospice the right way and truly improve the care we give, we must stick to science and evidence-based medical practices.

Posted in General | 11 Comments

From SBM — Updated on CAM Protection in Health Care Reform

Science-Based Medicine has posted a look at some of the language that has survived into current Senate and House versions of health care reform legislation. The woo protection elements are alive and well. Here are some examples:

 “insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law.”

“[community health teams may include] doctors of chiropractic, licensed complementary and alternative medicine practitioners…”

“provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services”

provide local access to the continuum of health care services in the most appropriate setting, including access to individuals that implement the care plans of patients and coordinate care, such as integrative health care practitioners”

“The term ‘health care workforce’ includes…doctors of chiropractic…licensed complementary and alternative medicine providers, integrative health practitioners”

a requirement that there be non-discrimination in health care in a manner that,…[protects] benefits for religious or spiritual health care”

“Prohibition of discrimination in health care services based on religious or spiritual content”

 

If anything, the language of the legislation seems to have gotten more protective of woo coming out of committee. *sigh* Politics may make strange bedfellows, but it is ridiculous and infuriating that part of the price for health care reform may be greater government protection of unproven and bogus medical therapies.

Posted in Law, Regulation, and Politics | 4 Comments

Parvovirus Outbreak in Idaho

A news report from The Olympian newspaper reports a localized outbreak of parvoviral enteritis, or “Parvo” in Southwest Idaho. According to the article, “Veterinary clinics and hospitals in Boise, Nampa and Caldwell are all reporting a spike in canines with symptoms of parvovirus. In some Treasure Valley clinics, the increase is 10 times the normal rate.”

Parvo is caused by a virus shed in the feces of infected dogs. Puppies are especially vulnerable to infection between 8 and 20 weeks of age, when the antibodies they receive from nursing gradually decline and their own immune system has not yet produced enough antibodies to be protective. Some breeds are more sensitive to the virus than others, but any puppy can become infected. And the virus is very robust, able to remain infective in the environment for months.

With a series of vaccinations, the disease can almost always be prevented. As discussed in my primer on veterinary vaccines, a series is necessary because the maternal antibodies block the vaccines, and the puppies own antibodies are produced gradually over time and take a while to reach protective levels. It is true that surviving the disease will lead to protective antibody levels, often for life. However, 20% of puppies with the disease will die, and many others will experience needless suffering.

Local vets in the area of the outbreak are theorizing that dog owners are neglecting to get all of the recommended puppy vaccine series due to the troubled economy. As the article correctly states, “The vaccine for parvovirus is very, very effective, 99.9 percent effective. It’s unfortunate to see so many cases because it does not have to happen,” said Dr. Kayla Williams of the Blayney Veterinary Clinic, which has treated 30 cases in the last four weeks.”

Outbreaks like this are unfortunate, but they provide needed reminders that vaccination is critical to prevent diseases like parvoviral enteritis, which persist at low levels in the population waiting for a lapse in vaccination to re-emerge as an epidemic. Vaccines are another medical tool that are in some ways hurt by their very success. Anti-vaccine propaganda can convince people such diseases are no longer a threat because most people who have properly vaccinated their pets will never see a case. Here is yet another piece of evidence that this is a dangerous myth.

Posted in Science-Based Veterinary Medicine, Vaccines | 5 Comments

Board Certified Woo — Or Should I Say Meow?

CAM proponents generally struggle against government regulation of their industry, though they will also often cite state licensure, when it is required, as evidence that their approaches are legitimate. However, in the absence of such a government imprimatur of legitimacy, CAM providers organize themselves into private “accrediting” organizations to lend gravitas to their business cards. As this article indicates, however, the standards are sometimes less than rigid. Apparently, even being a human being is not always required.

“Chris Jackson, presenter of Inside Out in the North East and Cumbria, registered pet [cat] George with three industry bodies. George was registered with the British Board of Neuro Linguistic Programming (BBNLP), the United Fellowship of Hypnotherapists (UFH) and the Professional Hypnotherapy Practitioner Association (PHPA).”

And lest we be tempted to assume the British system is somehow more lax than here in the U.S., Dr. Steve Eichel, a psychotherapist, managed not only to get his cat, Zoe, certified by the “National Guild of Hypnotists, the American Board of Hypnotherapy…the International Medical & Dental Hypnotherapy Association…[and] the American Association of Professional Hypnotherapists,” he even secured Diplomate status as a board certified member or the American Psychotherapy Association.

Just something to think about the next time someone rattles off an impressive string of professional credentials in support of some questionable therapeutic approach.

Posted in Humor | Leave a comment

Doctor Indicted for Selling Bogus “Cure” to Cancer Patients

I’ve discussed previously why it is both understandable that desperately ill people turn to unproven or bogus therapies and why it is immoral to take advantage of this desperation and sell them such therapies. It is comforting, then, to find that even in today’s CAM-friendly climate that selling lies and false hope to sick people is still illegal, at least sometimes. This case involves a doctor  who allegedly made $1.1 million dollars over three years selling a mysterious concoction of unknown provenance  and claiming it would treat cancer, hepatitis, Alzheimer’s, Parkinson’s, and other diseases. According to the Associated Press article, the doctor also instructed at least some of her patients to discontinue conventional therapy.

It is interesting, and a little disappointing, that the prosecution is focused on wire and mail fraud charges, since the law still is unable to deal directly with medical lying. Apparently, a California Medical Board investigation is underway, but I suspect the outcome will hinge more on the results of the criminal prosecution than the scientific facts about the treatment the doctor charged provided. After all, California licenses and promotes the legitimacy of acupuncture, chiropractic, and other questionable therapies.

Still, such cases serve to illustrate the reality behind the PR rhetoric of some CAM promoters. CAM providers, on balance, are likely honest believers in the therapies they sell. But their claims to the contrary notwithstanding, their ranks contain the recklessly negligent and the outright dishonest, so the stones they cast at scientific medicine’s faults are ill-advised coming from within their own glass house. And rather than providing comfort or real help to the truly ill, unproven therapies offer only the illusion of help while often taking away the potential benefits of real medical treatment.

Posted in Herbs and Supplements, Law, Regulation, and Politics | 4 Comments

Cognitive Dissonance and Evidence-Based Medicine

Cognitive dissonance is the emotional reaction to becoming aware that one holds two contradictory ideas or feelings simultaneously. It is a term from a rich area of cognitive psychology looking at how people derive and maintain beliefs. One of the best and most accessible works on the topic for the general public is Mistakes Were Made (But Not by Me) written by Carol Tavris and Elliot Aronson. The phenomenon of cognitive dissonance has relevance for the practice of  evidence-based medicine (EBM), as for most complex human endeavors, because it affects how we maintain old ideas and react to new ones.

One of the core principles of EBM is that due to a host of well-established factors both doctors and patients (or pet owners in veterinary medicine) often evaluate the effects of medical interventions inaccurately. Personal experience and observation, even by someone with extensive training and practice, is less reliable than controlled scientific study. The evidence for this is overwhelming, and a central reason for adopting the EBM approach is the acknowledgement that our common strategies for evaluating medical treatments are inferior. Unfortunately, but not surprisingly, telling people (especially doctors) this generates resistance, and sometimes hostility.

We generally view ourselves more positively than we view others. This extends not only to how we evaluate our own intelligence, attractiveness, and so on, but also how we evaluate our own objectivity, fairness, and rationality. When we are presented with evidence or argument that challenges not only the facts we accept to be true, but our own intellectual and personal qualities, cognitive dissonance comes into play. We tend to rationalize or outright reject our own mistakes, misperceptions, and errors partly because accepting them involves not only changing our beliefs about something else which is hard enough, but re-evaluating our beliefs about ourselves. (An excellent review of this topic is Emily Pronin’s paper How we see ourselves and how we see others. Science 320;1177-1180; 2008.)

Veterinarians (and MDs) are generally smart, conscientious people who genuinely want to provide the best possible care for their patients. And most of them likely see themselves this way. Most accept the general principles of EBM because they makes sense and are consistent with how they already see their work. Most doctors think they already practice EBM, despite data that show that not as much of conventional medical practice is founded on high-quality evidence as is generally believed (though certainly far more than CAM practices). Suggesting that they may be routinely mistaken about their diagnoses or therapies challenges this self-assessment, and this adds to the resistance to the conclusion. Research in human medicine shows much greater inconsistency and error rates among doctors then they themselves believe. There is no reason to suspect we veterinarians do any better in this respect.

One of the challenges, then, in promoting science-based medicine is to present the advantages of it in ways that minimize the dissonance and resistance that inevitably arise when the inadequacies of current practices are pointed out. When I criticize CAM or other approaches or attitudes within the profession, I am routinely accused of arrogance or of belittling the clinical experience of others. Of course, I feel I am simply advocating for a better and healthier approach to veterinary medicine, and my honest intent is to contribute to the growth and betterment of the profession. I have spent a great deal of time and effort evaluating the epistemological theory and the specific evidence for the subjects I discuss, and I think I have generally sound conclusions drawn from theory and evidence. But since I undoubtedly  have all the same cognitive weaknesses as everyone else, it is likely that sometimes I unskillfully or carelessly make my case in ways that are unnecessarily antagonistic. And it is likely that sometimes my conclusions are simply wrong.

There is a complex balancing act between acknowledging one’s own limitations and weaknesses while at the same time vigorously acting on one’s values and beliefs. The result is never perfect, but it is undoubtedly superior to unquestioning trust in one’s own intuition and experience. It requires personal and intellectual humility and also the converse, the willingness to confidently and assertively put forward one’s conclusions. And it is inevitable that EBM will generate resistance and controversy because it requires challenging and changing accepted practices, so one must be willing to be as honestly self-critical as possible yet still respond vigorously to such resistance.

In an odd way, the degree of cognitive dissonance one encounters is perhaps greatest when one is challenging approaches in the gray zone between established science-based medicine and outright CAM. Subjects I’ve addressed previously, such as probiotics, are ideas based on sound scientific principles and supportive preliminary laboratory data, unlikely clearly unscientific practices like homeopathy. And yet, when they are put into practice, usually as commercial products, before there is sufficient evidence to support such use, these ideas fall into conflict with the principles and practice of EBM. Yet because of their underlying plausibility and relationship to established medical practices they are often quickly accepted by veterinarians and doctors who have a generally scientific medical philosophy. These clinicians, then, are especially resistant to the suggestion that they are not adhering to their stated scientific values when they justify using such approaches because in their personal experience they seemed to have helped individual patients. Unlike the dedicated alternative medicine provider, who can always reject evidence by casting doubt on the relevance of science to what they are doing, doctors who support EBM in principle may experience cognitive dissonance when such gray-area practices are questioned.

The following are some excellent resources for investigating more deeply cognitive dissonance and the inevitable limitations and weakness in human reasoning that require us to rely on science to more closely approach a reliable understanding of reality, in medicine and life generally.

Don’t Believe Everything You Think: The 6 Basic Mistakes We Make in Thinking by Thomas Kida

Snake Oil Science by R. Barker Bausell

Predictably Irrational by Dan Ariely

On Being Certain: Believing You Are Right Even When You’re Not by Robert Burton

The Drunkard’s Walk: How Randomness Rules Our Lives by Leonard Mlodinow

Posted in General | 7 Comments

Veterinary Stem Cell “Research” — Is This the Best We Can Do?

As I discussed in a previous post, the call for a reliance on sound evidence in veterinary medicine resonates less strongly that we might hope because of the paucity of such evidence. Financial resources are the main limiting factor in obtaining good-quality basic and clinical research evidence, but apparently the attitude or culture of the profession may be a factor as well. According to a recent news story from the Veterinary Information Network (VIN), a widely used information and social resource for veterinarians, Dr. Richard Vulliet, a researcher and professor at the UC Davise School of Veterinary medicine has accepted a $100,000 grant from the AKC to study the use of bone marrow stem cells in degenerative myelopathy, a mysterious and all too common disease in which older dogs gradually lose the function in their hind legs.

Dr. Vulliet is clearly a trained, experienced researcher who should understand the importance of properly designed and conducted trials. Unfortunately, if the comments and attitude attributed to him in this article are correct, his frustration with the pace and limitations of proper research have led him to use the resources he has to “try out” some ideas without the structure or controls that make the results meaningful or useful to the rest of the profession.

According to the article, “Vulliet has treated four dogs with degenerative myelopathy with their own stem cells…Vulliet derives the mesenchymal stromal cells from bone marrow. He injects the cells systemically into the circulation because it appears that they home to an area of injury.”

The idea for the project apparently came from some laboratory rat research. “Vulliet says he got interested in treating these conditions because he was working with mesenchymal stem cells and their interaction with connective tissue, and it was boring. Then he came across two papers. In one of the papers, Japanese researchers described treating induced cardiomyopathy in experimental rats (Circulation 2005;112:1128-35)…Vulliet has not treated any dogs with dilated cardiomyopathy. But he has been in contact with Doberman groups to recruit possible subjects…In the other paper, researchers at Tulane University in New Orleans induced spine injuries in experimental rats and treated them with mesenchymal stem cells.”

Clearly, Dr. Vuillet recognizes some of the limitations of a research project based on limited information about plausibility and mechanism, “When I talk to possible clients, I generally get the impression they think I know what I am doing. But no, this is research.” Unfortunately, the limitations don’t seem to bother him as much as those of properly conducted scientific research, which he has chosen not to pursue because “the protocols he would be forced to adhere to at the university, working with pet dogs, would be too cumbersome.”

The article goes on to describe the haphazard followup of subjects, including one dog whose owner, apparently a neighbor of Dr. Vuillet, almost forgot to mention that she believed the dog had improved after treatment. The issue of potential hazards also arises, when the article  mentions that 1 of the 4 dogs treated so far eventually developed a “malignant tumor on its spleen.” Clearly, splenic tumors are quite common in elderly dogs of the breeds Dr. Vuillet is studying, but any association, causal or chance, between the treatment and such disease is unlikely to be detected by casual, unsystematic followup.

What Dr. Vuillet seems to be doing is selecting a few owner with dogs who appear to have degenerative myelopathy (though how that is confirmed is unclear from the article) and who appear to have sufficiently low expectations for benefit from the procedure, and then giving them some stems cells and asking the owner someday how things are going. The value of data collected this way is so low that it is hard to justify spending $100,000 of the scarce funds available for veterinary research on it. Even more disturbing, from someone who clearly ought to know better, are statements suggesting this independant,  idiosyncratic, approach to research is somehow superior to proper clinical studies; “ I think we will learn more from these dogs than from the thousands of Ph.D.s who are experimenting in the labs.”

If this is the attitude towards science that professors at our veterinary schools are teaching to their students, I fear that better studies and better data will not be more available in the future. And while I am only speculating, I will be very interested to see if Dr. Vuillet eventually introduces some version of stem cell therapy to the veterinary market as an entrepreneurial inventor in the coming years. Such a therapy would be more than welcome, and I would be eager to provide it to my clients, if the proper evidence for its safety and efficacy were available. I am doubtful, however, that such evidence will come from projects such as this one.

Posted in Science-Based Veterinary Medicine | 27 Comments

PEMF Device for Pets

Bioelectronics corporation has announced its intent to market a new device for treatment of osteoarthritis in pets. The device, the HealFast®Therapy PetPatch™, is a pulsed electromagnetic field (PEMF) device that attaches over a swollen or painful joint ad is intended to “to reduce swelling, relieve pain and enhance the healing of surgical incisions, accidental wounds, sprains, strains and chronic wounds.”

PEMF devices are widely available for human use, and as usual for CAM nostrums they are based on some suggestive in vitro and laboratory studies and weak clinical trial evidence. Electromagnetic fields do have measurable effects on cells in vitro, and there are some recognized medical uses for them. Some evidence suggests an improvement in outcome for non-union fractures, and there may be some benefit in terms of reduced pain and swelling following surgery. However, overall the evidence for clinical benefit is equivocal, as indicated by a number of review studies:

“All trials examined knee OA and one also performed a separate evaluation for cervical OA patients. The results of this analysis show improvements in all measurements for knee OA, but their clinical significance from a patient’s perspective was questionable. Only two outcomes favoured treatment for cervical OA trial and none were considered clinically important. There were no reported side effects. The reviewers conclude that there is an urgent need for further large-scale studies of pulsed electric stimulation with a focus on knee OA to establish the clinical relevance of treatment.” Cochrane Review

“We cannot make any definitive statements on the effects of electrotherapy for people with acute or chronic mechanical neck disorders (MND). Based on this review of 11 trials and 525 people with MND, the current evidence on Galvanic current (direct or pulsed), iontophoresis, TENS, EMS, PEMF and permanent magnets is either lacking, limited, or conflicting.” Cochrane Review

“McCarthy and colleagues (2006) noted that the rehabilitation of knee osteoarthritis often includes electrotherapeutic modalities as well as advice and exercise.  One commonly used modality is PEMF.  Its equivocal benefit over placebo treatment has been previously suggested.  However, recently a number of randomized controlled studies have been published that have allowed a systematic review to be conducted.  The authors concluded that this systematic review provides further evidence that PEMF has little value in the management of knee osteoarthritis.  There appears to be clear evidence for the recommendation that PEMF does not significantly reduce the pain of knee osteoarthritis.”AETNA insurance company literature summary

“In a randomized, placebo-controlled study, Ay and Evcik (2008) examined the effects of PEMF on pain relief and functional capacity of patients with knee osteoarthritis.  A total of 55 patients were included.  At the end of treatment, there was statistically significant improvement in pain scores in both groups (p < 0.05).  On the other hand, no significant difference was observed within the groups (p > 0.05).  These investigators observed statistically significant improvement in some of the subgroups of Lequesne index (e.g., morning stiffness and activities of daily living) compared to the placebo group.  However, these researchers could not observe statistically significant differences in total of the scale between two groups (p > 0.05).  Applying between-group analysis, the authors were unable to demonstrate a beneficial symptomatic effect of PEMF in the treatment of knee osteoarthritis in all patients.  They stated that further studies using different types of magnetic devices, treatment protocols and patient populations are warranted to confirm the general efficacy of PEMF therapy in knee osteoarthritis and other conditions.” AETNA insurance company literature summary

“Furthermore, in a systematic review on wound care management, Cullum, et al. (2001) concluded that there is generally insufficient reliable evidence to draw conclusions about the contribution of laser therapy, therapeutic ultrasound, electro-therapy and electromagnetic therapy to chronic wound healing.  Flemming and Cullum (2001) also concluded that there is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers.” AETNA insurance company literature summary

 

This would seem to suggest that a responsible company would make an investment in investigating a promising therapeutic concept in the hopes of eventually finding a beneficial, and presumably profitable, product. Unfortunately, as I’ve discussed before this instead is seen as a perfect opportunity to make a quick buck selling something based on its promised rather than its demonstrated value. What is especially disturbing about the Bioelectronics’ press release is the unabashed trumpeting of the potential profit to be made and the clearly stated intent to market the device directly to consumers, bypassing the veterinarians who presumably might have troubling questions about the evidence behind the company’s claims: “A comprehensive direct to consumer marketing program will support the launch of the new product. The centerpiece of the campaign is a new TV commercial which will begin rolling out next week.”

 

So for those of you who are veterinarians, be prepared for the clients who will soon be coming to you having seen the new commercial. Hopefully, they’ll be seeking you advice, but unfortunately it’s always dissatisfying for client and vet alike to have to answer the glowing testimonials and marketing hype for one of these products by a sober and bland summary of equivocal research evidence. Still, that’s our job!

Posted in Miscellaneous CAVM | 17 Comments