CAM and the Law Part 3: Malpractice Law

Posted on December 14, 2010 by skeptvet

This is a cross-post from Science-Based Medicine- CAM and the Law Part 3: Malpractice Law 

It is with some trepidation I venture into the next subject in this series — malpractice law. This is a touchy subject for healthcare providers, for obvious reasons. Regardless of the flaws in the system, however, malpractice law is one of the mechanisms put in place by government to regulate the practice of medicine. Like the other such mechanisms touched on so far, licensure and scope of practice law, malpractice laws apply to alternative medicine practices in ways that are broadly similar, but sometimes subtly and significantly different, from how they apply to scientific medicine. 

So far, alternative practitioners are sued for malpractice relatively infrequently compared with physicians, presumably because they represent a much smaller fraction of the care provided, they tend to be utilized by those with an ideological bias in favor of their approaches, and they are not viewed as nearly as rich a target for litigation. But this may change if the political and cultural winds blow in the direction of greater utilization of alternative medical approaches. 

General Principles of Malpractice Law

In order to establish a claim of medical malpractice, a plaintiff must show four basic elements.1

1. A duty was owed by the defendant to the plaintiff.
2. That duty was breached.
3. The breach was the proximate cause of an injury.
4. The injury involved actual damages.

It is in the interpretation of what constitutes a duty and the breach thereof and the establishing of causation that much of the opportunity for judicial interpretation lies. Such interpretation also comes into play when typical defenses against malpractice claims are invoked, such as theories of contributory negligence and assumption of risk. One of the most contentious issues with regard to malpractice cases involving alternative therapies is what constitutes an appropriate standard or care, which defines the duty and condition of breach.

Standard of Care

Traditionally, medical doctors accused of malpractice were judged according to the so-called “local rule,” in which a doctor was expected to adhere to the standards of other doctors in his or her geographic area. This has been largely supplanted by the “national rule,” in which physicians are judged by the standard or other physicians in the same specialty.1 However, what about chiropractor, acupuncturists, naturopaths, etc? What standard is used to judge their duty and quality of care? (It may seem in the subsequent discussion and examples that I am picking on chiropractors. This is just an artifact of the volume of legal opinions concerning this method, since chiropractors are the most widespread, legally recognized, and often sued of alternative medicine practitioners).

A key case looked to as a precedent in many states was Kerkman v. Hintz, argued before the Supreme Court of Wisconsin.2 In this case, a patient was seen by a chiropractor, diagnosed with a cervical subluxation, and treated with several chiropractic adjustments. His condition worsened, whereupon he was seen by a neurosurgeon who identified a ruptured intervertebral disk. After two surgeries for this, the patient had significant lingering disability. The patient sued the chiropractor for malpractice, arguing that the D.C. ought to have recognized that his problem was not suitable for chiropractic treatment and referred him for appropriate care.

The legal standard of care invoked by the plaintiff in this case was a 1923 ruling in which it was held that “in evaluating a patient’s condition prior to treatment, a chiropractor must exercise the same degree of care and skill which is usually exercised by a recognized school of the medical profession.”3 However, the state supreme court overruled this precedent, arguing that while chiropractors were not a separately licensed profession in 1923, and so could be viewed as just another “recognized school of medicine,” by 1988 the practice of chiropractic had been defined, limited, and specifically distinguished from the practice of medicine by state licensing statutes. Since these statutes limit chiropractors to “the analysis and correction of subluxation,” it is not appropriate to allow or require them to make medical judgments that go beyond this. The court did not seem perturbed at all by the issue of whether the “subluxation” was a real medical entity or a phantasm. It was only concerned about whether it was a recognized entity from the point of view of state law, which it is.

Based on this reasoning, the court established a new standard for chiropractic.

In summary, we hold that a chiropractor has a duty to (1) determine whether the patient presents a problem which is treatable through chiropractic means; (2) refrain from further chiropractic treatment when a reasonable chiropractor should be aware that the patient’s condition will not be responsive to further treatment; and (3) if the ailment presented is outside the scope of chiropractic care, inform the patient that the ailment is not treatable through chiropractic means. In determining whether a chiropractor breaches these duties, the chiropractor is held to that degree of care, diligence, judgment, and skill which is exercised by a reasonable chiropractor under like or similar circumstances.2

Moreover, the court specifically exempted chiropractors in Wisconsin from any duty to refer patients for care by a physician.

Having explained to the patient that the problem is not within the chiropractor’s license to treat, the chiropractor does not have a duty to refer the patient to a medical doctor…because implicit in a requirement that a chiropractor refer a patient to a medical doctor is the imposition on the chiropractor to make a medical determination that the patient needs medical care, such a determination could not be made without employing medical knowledge. Because a chiropractor is not licensed to make such a determination, we hold that a chiropractor does not have a duty to refer.2

From a science-based perspective, of course, this seems ludicrous. Chiropractors are specifically licensed to treat an imaginary cause of diseases, and they are given the sole authority to decide as a community which illnesses will or will not respond to treatment of this faux etiology. They are expected to tell patients when their treatment is not going to work, but they aren’t expected to recognize if these same patients have a condition for which they should be seen by a medical doctor, because making that judgment would require them to know something about real medicine, which they are legally prohibited from doing. 

Kerkman v. Hintz is a widely cited ruling that has had a significant impact on the assessment of standard of care for alternative medicine practitioners, but not all states follow this opinion, and other courts or state legislatures have imposed a duty to refer on chiropractors. The Supreme Court of New Jersey, for example, ruled in a 1984 case that chiropractors are “expected to diagnose and refer patients whose conditions require medical or other treatment.”4 Other appeals courts, in Washington and Colorado for example, have also upheld judgments against chiropractors for failing to recognize a problem they were not qualified to treat and for not referring the patient to a medical doctor. 

And in California, the regulations that govern licensed chiropractors in that state specifically identify failure to refer a patient whose condition is not amenable to chiropractic treatment as an example of “unprofessional conduct.”5 This is ostensibly only intended to be the basis of action against the license of the chiropractor, but some scholars hold that such regulatory provisions can be the basis for establishing a standard of care in a malpractice case. There are, however, also rulings that do not allow practice act standards to be used in this way (e.g. Wengel v. Herfet Court of appeals of Michigan (1991) 6). As usual, then, there is a lack of consistency among the states in the legal theories or specific interpretations of relevant law and precedent.

Breach of Duty or Standard of Care

Once a standard of care is defined, a malpractice case hinges next on whether this standard has been breached. In addition to failing to recognize a problem not amenable to the alternative method of treatment being used, and failure to refer for medical care where required, there are several other ways in which alternative practitioners may breach the applicable standard of care.

For physicians utilizing alternative therapies, one possible breach of the standard of care is simply by utilizing methods that deviate from accepted medical practices. In a case involving Dr. Nicholas Gonzalez, of the infamous Gonzalez Regime for cancer treatment, the Supreme Court of New York articulated what seems to me a simple and rational view of the issue that is seldom seen outside of science-based medicine advocacy circles:

The standard for proving negligence in a malpractice case is whether the treatment deviates from accepted medical standards…it would seem then that no practitioner of alternative medicine could prevail on such a question as the reference to the term “non-conventional” may well necessitate a finding that the doctor who practices such medicine deviates from “accepted” medical standards. This indeed creates a problem for such physicians which perhaps can only be solved by having the patient execute a comprehensive consent containing appropriate information as to the risks involved.7

In other words, since alternative medicine by definition does not conform to accepted standards of care, it should only be defensible if it is undertaken as an experimental therapy, with all of the informed consent requirements and other protections for patients participating in clinical trials. 

Of course, this standard only applies to medical doctors who employ alternative methods, so the principle unfortunately cannot be applied to chiropractors or others licensed in specific alternative methods who are held to different standards. And in practice, alternative therapies are usually not subject to automatic classification as malpractice by virtue of being alternative, because the courts have more frequently held that they should not be judged by the standards of conventional or scientific medicine, but only by their own internal standards.

Malpractice Defenses

The most straightforward defenses against a malpractice claim (insofar as any issue subject to litigation can ever be straightforward) are that the actions of the defendant were not the cause of any injury and that no actual damages were sustained. These are, for the most part, questions of fact which can often be substantiated in relatively objective ways. However, greater ambiguity and complexity are involved in defenses which address whether a duty of care exists or has been breached. 

As we have seen, alternative practitioners have some avenues of defense in arguing that they cannot be guilty of breaching a duty based on standards of conventional medicine but only on those limited standards that pertain to their particular mode of treatment. One form this defense takes is the so-called “two schools of thought” doctrine.8 This is a Byzantine bit of legal reasoning in which the courts try to avoid adjudicating scientific disputes between factions within the medical community. This seems at first a quite appropriate goal given that lawyers, judges, and juries are not generally qualified in knowledge or training to determine the scientific truth behind disputes among scientists. 

However, it leads to the unfortunate consequence that courts may make the mistake journalists so often make of treating the two “sides” in a scientific dispute as equal when in fact the dichotomy may actually be between an overwhelming majority backed by solid evidence and a few extremists with a wild, unsupported notion.

One case before the Supreme Court of Pennsylvania, Jones v. Chidester, illustrates this doctrine nicely.9 According to the court, “a medical practitioner has an absolute defense to a claim of negligence when it is determined that the prescribed treatment or procedure has been approved by one group of medical experts even though an alternate school of thought recommends another approach.” 

The court then examines in detail different standards previous courts have used to determine whether a given position constituted a legitimate “school of thought” to which this rule could be applied. Some courts have used a quantitative standard, ruling that a “considerable number” of experts must approve of an approach for it to be deemed legitimate. Other courts have used a more qualitative standard, for example acceptance of the approach by “respectable, reputable, and reasonable” practitioners. The most generous standard seen in some states is requiring only a “respectable minority” of physicians to agree with an idea for it to be an acceptable “school of thought.” Ultimately, the Pennsylvania court chose to apply a combination of quantitative and qualitative standards:

Where competent medical authority is divided, a physician will not be held responsible if in the exercise of his judgment he followed a course of treatment advocated by a considerable number of recognized and respectable professionals in his given area of expertise.8

The court left the details of words like “considerable” and “recognized” or “respectable” to the discretion of other courts hearing particular cases. And they specifically placed the onus of supporting the contention that one’s approach is a legitimate “school of thought” on the defendant: “The burden of proving that there are two schools of thought falls to the defendant. The burden, however, should not prove burdensome…Once the expert states the factual reasons to support his claim that there is a considerable number of professionals who agree with the treatment…there is sufficient evidence to warrant an instruction to the jury on the two ‘schools of thought.’ It then becomes a question for the jury to determine whether they believe that there are two legitimate schools of thought such that the defendant should be insulated from liability.”8

Clearly, under this doctrine widely accepted practices like chiropractic and acupuncture would qualify as legitimate schools of thought, and no claim of liability based solely on the scientific evidence against their claims would be allowed. This leads to a pretty glaring inconsistency. The courts wish to avoid adjudicating scientific disputes, and yet as an alternative they make determining the legitimacy of a medical therapy a sort of popularity contest and then leave it to a jury to decide if the approaches employed are sufficiently popular to be acceptable.

Informed Consent and Assumption of Risk

In addition to straightforward factual defenses and to the approach of establishing that one’s treatment  is consistent with the practices of a legitimate “school of thought” within the medical community, practitioners accused of malpractice can defend against liability by arguing that the patient had implicitly or expressly assumed any risk of treatment by assenting to the treatment, thus absolving the practitioner of liability for damages. As The U.S. Court of Appeals for the Second Circuit argued, “we see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment. While a patient should be encouraged to exercise care for his own safety,[eschewing conventional treatment] is within a patient’s right ‘to determine what shall be done with his own body.”10 And if a patient makes such an informed decision, then it would make no sense to hold the practitioner liable for any undesirable outcome that was an inherent risk of the treatment. 

In order to lay the basis for this assumption of risk defense, practitioners need to inform patients of the potential risks of treatment and of the alternatives. Courts have wrestled with the details of defining the parameters of this informed consent. There are two dominant standards in use. About half of the states use the so-called “patient standard,” in which a provider is expected to disclose any fact which might reasonably be expected to affect the patient’s decision whether or not to undergo the therapy. No expert testimony is required to establish if adequate disclosure occurred under this standard because this would imply that medical experts, rather than lay people, should determine what constitutes adequate disclosure, and this is considered by some to be paternalistic or open to abuse if physicians ultimately decide what patients need to know. 11

The rest of the states use the “professional standard,” which requires disclosure of any fact that a reasonable physician in the same circumstances would disclose. Under this theory, expert testimony is needed to establish what a “reasonable physician” would be expected to do in the specific circumstances and whether or not the defendant did it.12

How then are the principles of informed consent and assumption of risk applied in malpractice cases associated with alternative medicine? In one scenario, a provider may be sued for failing to adequately disclose the risks of forgoing conventional medical care. 

An example of this is the case previously referenced, Charell v Gonzalez, in which a victim of the Gonzalez cancer regime sued Dr. Gonzalez after undergoing his bogus treatment. In this case, the state supreme court did find that Dr. Gonzalez failed to provide adequate disclosure concerning the risks of his therapy and of eschewing conventional cancer treatment. However, the court also concluded that the patient “was a well-educated person who, together with her husband and daughter, did a significant amount of investigation regarding the treatment…and hence became quite knowledgeable on the subject…[Thus] it was within the province of the jury, based on the evidence, for it to find that plaintiff independently obtained sufficient information about the treatment so as to conclude that there was an implied assumption of risk when she agreed to follow defendant’s protocol.”7

By this reasoning, it would seem very difficult for someone who sought out an alternative therapy to successfully sue for malpractice even if the risks of the therapy were not adequately explained to them since it might be assumed by the court that in seeking the therapy they had discovered and understood the risks well enough to make an informed choice to accept them.

Of course, alternative practitioners may be sued, just like physicians, for failing to adequately disclose the risks of the therapies they provide. When his happens, the courts will judge the duty to disclose under whichever of the two standards described above is used in that jurisdiction, the “patient” or “professional” standard. However, the details of the risks involved and what the practitioner can reasonably be required to know and disclose are likely to be judged by the standards of the particular “school of thought” the practitioner belongs to. 

Therefore, for example, the court may view the risk of stroke associated with cervical chiropractic manipulation as chiropractors do, as an unproven or at least very rare complication balanced by the overall safety and efficacy of the treatment, rather than as a thoroughly unjustifiable risk of an ineffective and unscientific treatment, as many of us in scientific medicine view it.

In a strange twist to informed consent rules, some physicians have been sued for not informing patients of the availability of alternative therapies. So far the courts seem to have taken the position that there is no duty to inform a patient of the availability of a therapy that is generally not accepted by the medical community. However, as more doctors and medical schools integrate alternative therapies into their practices, there may come a time when not telling a patient that they could try acupuncture, chiropractic, or some other form of alterative therapy instead of conventional treatment could be viewed as a failure to provide sufficient disclosure to allow an informed consent/assumption of risk defense.

Summary

As usual, of course, the rules and standards set by state legislatures and courts are inconsistent and variable, so firm, predictable rules cannot be deduced. However, it is possible to make a few tentative generalizations about the position of alternative medicine with regard to malpractice law:

  1. Alternative therapies generally cannot be successfully attacked through malpractice litigation solely on the basis of their implausibility or lack of convincing scientific evidence for safety and efficacy. Particularly in the case of widely accepted and often state licensed approaches such as acupuncture and chiropractic, charges of malpractice will be judged by standards set within the paradigm of the particular method, not by any broader scientific or evidence-based standard.
  2. Alternative medicine providers can, of course, be guilty of malpractice if they perform their interventions below the commonly accepted standards of their own communities. They may also have liabilities for injuries caused by discouraging patients from seeking conventional care and, in some jurisdictions, for not recognizing when a patient’s condition is beyond the scope of their form of treatment and subsequently referring the patient for treatment by a medical doctor.
  3. The courts and legislatures give great weight to the autonomy of the individual to make decisions about their own healthcare, and they are likely to view sympathetically malpractice defenses based on the theory that by choosing an alternative approach a patient understands and assumes the risk of that approach.
  4. The licensure of alternative methods by states, their integration into academic institutions, and the tacit approval of their legitimacy conveyed by government organizations like NCCAM and insurance provider who pay for them all contribute to the perception of these methods as legitimate alternatives to scientific medicine, and this makes it very difficult for patients injured by these approaches to successfully pursue a malpractice action despite the lack of good scientific evidence that these methods are safe and effective. As we have seen repeatedly, when evaluating alternative medicine the law is far less concerned with scientific evidence than with political, cultural, and philosophical arguments.

References

  1. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010 Return to text.
  2. Kerkman v. Hintz, Supreme Court of Wisconsin, 418 N.W. 2d 795 (1988). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 103-11. Return to text.
  3. Kuechler v. Volgman, 180 Wis. 238, 192 N.W. 1015 (1923). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 105. Return to text.
  4. Rosenberg v. Cahill, 492 A.2d 371, N.J. (1984). from website: http://www.fpamed.com/forensic_psychiatry/2008/05/a-paradox-about.html Return to text.
  5. State of California, Board of Chiropractic Examiners Rules and Regulations, Rev. June, 2010. Article 2, § 317. from website: http://www.chiro.ca.gov/res/docs/pdf/business/chiroregs_june2010.pdf Return to text.
  6. Wengel v. Herfert, Court of Appeals of Michigan, 473 N.W.2d 741 (1991). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 114-16. Return to text.
  7. Charell v. Gonzalez, Supreme Court of New York, New York County, 173 Misc. 2d 227 (1997). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 117. Return to text.
  8. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 146-152. Return to text.
  9. Jones v. Chidester, Supreme Court of Pennsylvania, 531 Pa. 31 (1992). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 146-152. Return to text.
  10. Schneider v. Revici, United States Court of Appeals for the Second Circuit, 817 F.2d 987 (1987). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.152-4. Return to text.
  11. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 160-73. Return to text.
  12. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 174-8. Return to text.
Posted in Law, Regulation, and Politics | Leave a comment

Safety and Efficacy of NSAIDs for Canine Arthritis

Posted on December 11, 2010 by skeptvet

A common justification for the use of alternative therapies, with or without evidence concerning safety and efficacy, is that they are appropriate when conventional medicine does not have an established effective treatment for the problem. This is a legitimate argument in that there is always a balance to be struck between the degree of uncertainty about whether a treatment works or is safe and the urgency of treatment. For mild, self-limiting diseases there is little excuse for using therapies of uncertain safety or efficacy. And when there is ample evidence a therapy is ineffective (such as homeopathy) or unsafe (such as cervical chiropractic treatment or some herbal remedies), there is no justification for its use.

But if there is a significant clinical problem for which science has not yet found a safe or effective therapy, there is some justification for accepting the risk and uncertainty of using an unproven approach, so long as the patient/client understands the degree of uncertainty and the unpredictability of the outcome. Despite the assumptions and accusation of some alternative medicine proponents, those of us dedicated to science and evidence-based medicine don’t object to trying unproven approaches when there is little else available. What we object to is offering these approaches with unjustified claims about their safety and efficacy based on anecdote, personal experience, of scant and sloppy research. Whether it is ostensibly “scientific” treatment like adipose-derived stem cell therapy or clearly unscientific approaches like “energy medicine” and the like, there is an ethical duty on the practitioner offering the unproven method to provide honest, objective disclosure to the client or patient about the state of the evidence so they can make an informed decision balancing the needs of the patient and the potential risks and benefits of treatment.

Far more often, however, this argument is used to justify the use of alternative therapies when there really are established, science-based treatments available. In the case of arthritis in dogs, for example, there is a long list of unproven or disproven alternative therapies available, such as acupuncture, fish oil supplements (and here), electromagnetic devices, fat-derived stem cell injections, and of course the ubiquitous glucosamine, which seems to be taken by nearly every dog I see as a preventative of therapy for arthritis despite the voluminous evidence that it has no benefit (c.f. 1, 2, and 3). These therapies range from safe but useless (such as glucosamine) or safe but with little demonstrated benefit (acupuncture), to truly uncertain long-term safety and efficacy (such as stem cell therapy and most herbal approaches). But apart from the evidence against the claims that these treatments help, the argument for their use is further weakened by the existence of safe and effective conventional treatments for arthritis in dogs.

Much arthritis in dogs is related to congenital or developmental diseases, such as hip and elbow dysplasia, which can be prevented through aggressive testing and breeding programs and proper nutrition for puppies. Arthritis secondary to such problems can also be prevented by timely surgical treatment (and here) of affected animals.

A prime factor in the development of arthritis and its symptoms, for both humans and dogs, is obesity. There is good evidence that controlling weight is a very effective therapy for canine arthritis (1, 2).

And, of course, there are many effective medications for the treatment of osteoarthritis in dogs. The best among these are the non-steroidal anti-inflammatory drugs (NSAIDs), though drugs such as tramadol, gabapentin, amantidine, and other can be of benefit. In every study or review of arthritis treatment for dogs, nothing comes close to the effectiveness of NSAIDs (c.f. 1, 2, 3).

Of course, as I have often said, there is no free lunch in physiology. The body is a complex system with innumerable interactions, and anything that has a beneficial effect on one element of the system is going to have effects on others as well, and not always beneficial effects. Despite the claims of something for nothing often made by proponents of alternative therapies, anything that helps will have some risk of harm. Unfortunately, proponents of alternative therapies for arthritis frequently downplay the benefits and exaggerate the risks of conventional therapies, and NSAIDs in particular seem to generate a lot of unjustified fear and hysteria.

A recent paper reviewed the literature concerning the safety and efficacy of these drugs in dogs:

Innes JF, Clayton J, Lascelles BD. Review of the safety and efficacy of long-term NSAID use in the treatment of canine osteoarthritis. Vet Rec. 2010 Feb 20;166(8):226-30.

As usual, the quantity and quality of the veterinary research on the subject is less than ideal. However, a number of studies have been conducted, and they show unequivocal efficacy. Most subjective measures by owners or veterinarians improve by close to 90%, and when objective measures are used they almost always show clear benefit. Certainly, these results are far stronger than the equivalent results in studies claiming positive effects for glucosamine and many other alternatives to NSAIDs. And there is even some limited evidence that these drugs may reduce the development or progression of arthritis, though the findings are only preliminary and may or may not turn out to be clinically relevant (1, 2)

And what about the risks? The quality of the data on this subject was often poor, especially given that placebo controls were not used in many studies, which would tend to exaggerate the appearance of harm done by the drugs. However, the rate of adverse events ranged from 0 to 0.31 with no significant difference in the rate of adverse events between the NSAID and placebo when placebos were used. out of 1589 dogs in the studies reviewed, only 1 experience a severe reaction requiring hospitalization for treatment.

Other evidence, including trials used to gain FDA approval, show that dogs on NSAIDs can experience minor problems, such as self-limiting vomiting and diarrhea, or potentially more severe problems such as stomach bleeding, worsening of pre-existing kidney disease, or liver failure. However, the rates of these problems are extremely low, and they must be balanced against the life-limiting pain caused by arthritis, the clear efficacy of NSAIDs in relieving this pain, and the great deal of uncertainty about the safety or benefit of alternative treatments.

Owners can only evaluate the risks and benefits of treatment options if they have accurate information about these. It is a disservice to our clients and our patients to guide them towards unproven therapies, at the risk of unexpected side effects or continuing, unrelieved pain, on the basis of inaccurate or exaggerated assessments of the risk of established therapies such as NSAIDs. These are very effective and very safe medications which literally save the lives of thousands of animals who would be euthanized due to pain and unacceptable quality of life without this treatment.

Posted in Science-Based Veterinary Medicine | Comments Off on Safety and Efficacy of NSAIDs for Canine Arthritis

How Nutraceutical Research Should be Done: Lycopene for Osteosarcoma in Dogs

Posted on December 3, 2010 by skeptvet

Proponents of nutraceuticals, nutritional supplements thought to have therapeutic or preventative effects, often promote the use of such products despite little or no legitimate evidence to suggest they will be safe or helpful. When skeptics challenge these unsupported claims, they are frequently accused of being opposed to nutraceuticals or supplements per se regardless of the evidence, or of not wanting such things to be studies for fear that “free” remedies (not that any of these aren’t making a buck for somebody) would crowd the drug companies’ territory.

These are empty strawmen, of course, but it is true that I often find myself criticizing the inadequate evidence given to support using such products, or the poor quality of the research cited. I am pleased, then to be able to cite an example of how good quality, science-based research into the potential benefits of nutritional supplements should be done.

Wakshlag JJ, Balkman CE. Effects of lycopene on proliferation and death of canine osteosarcoma cells. American Journal of Veterinary Research 2010;71(11):1362-70.

The authors begin by pointing out that despite the fact “there is little evidence that single dietary carotenoids are beneficial,… carotenoid-rich nutraceuticals are available as over-the-counter products in both the veterinary and human market, and the incidence of nutraceutical use in pets with cancer is approximately 40%; therefore, understanding the functional importance of such carotenoids is extremely important, particularly when other chemotherapuetic agents are used.” The market, and those making money selling such supplements, are as usual well ahead of the research. However, there is some evidence of possible benefit in humans, so preliminary, pre-clinical studies to see if there might be benefit in dogs is appropriate.

One level of such research is showing that the substance can be taken orally by dogs and reach meaningful levels in the blood. One of the weaknesses in the preclinical data concerning glucosamine was the uncertainty over this point, which ought to be established before resources are wasted on clinical trials. According to the authors of this paper, such studies have been done and do show potentially meaningful blood and tissue levels of lycopene can be achieved by oral administration, so there is enough plausibility to justify further research.

The current study was intended investigate whether lycopene has an effect on canine osteosarcoma cells in vitro (that is, outside of the body), and also critically whether or not the substance appears to interfere with the effect of a common chemotherapy drug used against this cancer. As I’ve mentioned before, Vitamin C has been shown to potentially reduce the effectiveness of chemotherapy, and since many of the supplements now touted for cancer treatment are anti-oxidants, there is a real risk that they will interfere with the oxidative mechanisms by which established cancer treatments work, yielding a net loss for patients. In this case, the lycopene did seem to have a significant effect inhibiting the growth of the cancer cells, and it did not seem to enhance nor impede the effect of the chemotherapy agent tested.

Now, in vitro studies are important in establishing potential mechanisms by which drugs might have benefits, and in identifying potential sources of harmful effects. But the test tube is not the body, and they are not very reliable guides to the chances for real-world benefits in actual patients. After all, bleach kills cancer cells in a test tube, but it wouldn’t make a very good drug for cancer patients. The overwhelming majority of substances that show promise in the lab turn out not to be useful in actual patients, which is part of why development of effective medicines is so expensive.

Proponents of herbs and dietary supplements often try to support their claims with such laboratory research without recognizing the important limitations of such studies. To their credit, the authors of this paper not only did excellent research, but they recognized the limits to what their research means.

…regardless of the similar biological nature of osteosarcoma cells clinically, their reactivity to antineoplastic agents in vitro and in soft agar assays can differ dramatically from their in vivo reactivity, and further investigation into the antiproliferative effects of lycopene in vivo would be needed to prove the potential efficacy of such treatment.

Lycopene concentrations in tissue range from 100nM to 5?M, which makes tissue distribution highly variable but promising depending on tumor location. However, without knowing tissue concentrations of lycopene in tumors and having knowledge about cellular distribution, any suggestions of physiologic relevance are merely speculative.

The fact that physiologic doses of lycopene may be achievable in dogs, in conjunction with the efficacy of the in vitro study reported here, warrants future investigation into the use of lycopene as a chemopreventative, and possibly even as a chemotherapeutic, agent in the treatment of osteosarcoma in dogs.

It is likely that this study will eventually be cited in support of recommending lycopene for dogs with osteosarcoma. Regardless of whether or not the substance eventually turns out to be useful for treating this cancer, recommending it on the basis of this paper would be inappropriate. The authors themselves have the humility to understand this and not to extend the significance of their results beyond appropriate bounds. I wholeheartedly support such research, and I agree that the plausibility suggested by this report justifies further study.

While it is painful to see patients in my practice suffering from osteosarcoma, and to not have therapies as safe and effective as I would like to offer them, I understand, as do the authors of this excellent study, that I am doing my patients no service by recommending supplements that have yet to demonstrate they are safe and effective unless I am prepared to do so within the context of a research project appropriately designed to find this out. False hope and uncontrolled, haphazard use of nutraceuticals is not good for our patients, and if we really want to help them we must have the humility and discipline to accept and disclose the limitations in our knowledge.

I hope the authors of this study continue to pursue this promising line of research, and if at the end of the line is a therapy of real benefit I will be joyful. And if the end of the line is one of the far more common dead ends, I am confident the authors will see and accept that and move on to investigate other promising avenues. Such careful and honest work is why science-based medicine is so successful.

Posted in Herbs and Supplements, Science-Based Veterinary Medicine | 1 Comment

Politics Trumps Science: Continuing Education Credit for Pseudoscience thanks to the AHVMA

Posted on November 25, 2010 by skeptvet

I’ve written before about the ludicrous subjects the American Holistic Veterinary Medicine Association offers “continuing education” courses on, including “Earth Acupuncture” to heal the Earth by poking sticks in the ground and adoption into a fake Native American religion to avoid federal laws concerning use of drugs and other medical therapies, as well as the more usual nonsense therapies such as homeopathy and homotoxicology. In my previous post, I also discussed briefly the process by which educational offerings qualify for credits needed to maintain licensure as a veterinarian, via the Registry of Approved Continuing Education (RACE) established by the American Association of Veterinary State Boards (AAVSB). There is no point to requiring veterinarians to stay current on the scientific knowledge in their field if there were no standards for what qualified as continuing education. Getting credit for a course on using astrology to choose the timing of drug therapies or some such would violate the intent of the continuing education requirements, to ensure the public that licensed veterinarians are knowledgeable about the current science in their field.

However, the RACE committee and the AAVSB are, like all organizations involved in medical licensure and regulation, subject to the influence of politics and the ideologies of its members. The quality of scientific evidence concerning a medical approach is not always the deciding factor in whether or not teaching this approach can qualify as continuing education for licensing purposes.

Recently the most ridiculous pseudoscience promoted by the AHVMA has failed to qualify for RACE approval as continuing education. This has been due in large part to the effort of RACE committee member Dr. Narda Robinson. While Dr. Robinson and I disagree about the evidence supporting some CAVM methodologies, most notably acupuncture, she does at least attempt to do what many proponents of alternative medicine do not, which is to apply an objective scientific standard to evaluating CAVM. The natural consequence of this approach is, of course, not to legitimize pseudoscience by supporting it as continuing education material for veterinary licensure.   

The AHVMA is, not surprisingly, seeking ways to gain such legitimacy regardless of the lack of sound scientific support for some of the nonsense they promote. And they are clearly attempting to use political means to accomplish this, which is certainly easier and more likely to succeed than trying to rigorously test their methods scientifically to see if they actually work.

The AHVMA web site provides links to a couple of documents concerning the continuing education credit process. First, regarding RACE and Dr. Robinson:

The RACE committee denied approval for CE credits for over 60% of the 2009 AHVMA annual conference. AHVMA appealed this and as of October 14, 2010, had still not heard about any decision of the AAVSB (parent organization of RACE). After the conference we received notice that AAVSB had denied our appeal. Their website states that the appeal is directed to the AAVSB Board of Directors. However, the letter of denial indicated that if it has merit, they direct it back to the RACE committee for final evaluation. We would not have bothered with this procedure if we had known it would be submitted back to the RACE committee, since we already know the attitude of the RACE committee’s sole judge of CAVM, Narda Robinson.

Subsequent to their communication with us, the RACE committee has denied credit to an increasing variety of CAVM meetings. At the same time, many states have approved those meetings for CE credit. Most states have reciprocity with other states for approved CE. AHVMA applied to the state of Kentucky for approval of this meeting for CE credits. Just before the meeting we were told that because we do not have RACE certification, we are not approved in Kentucky. However, with the help of convention center staff, we hope to reverse this at the next meeting of the Kentucky state board in December.

They go on to detail the specific courses that have qualified for credit by specific membership organizations, which often have their own requirements apart from those needed to maintain one’s state license. Not surprisingly, the Academy of Veterinary Homeopathy doesn’t share the persnickety scientific standards of the RACE committee and accepts most of the AHVMA’s offerings.

Another document on the AHVMA site discusses directly the “CE Approval Crisis for AHVMA and other CAVM organizations.”

The RACE committee of the AASVB is the body that approves courses for continuing education credits, given by organizations that are not part of the AVMA House of Delegates. In December 2008, Narda Robinson was appointed as the sole person on the RACE committee of the AASVB to judge Complementary and Alternative Veterinary Medicine (CAVM). In 2009, the RACE committee denied CE credits for all homeopathic and homotoxicology meetings. They denied credit for most acupuncture and Chinese herbal medicine that included Traditional Chinese Medicine.

Can you imagine not allowing credit for such standard veterinary practices as homeopathy, homotoxicology, or Traditional Chinese Medicine? A crisis indeed.

Sadly, the AHVMA has found at least some political solutions to this “crisis” which do not require they provide real scientific evidence for the subjects they wish to offer as continuing education. In California, for example, courses offered by the California Veterinary Medical Association (CVMA), a membership organization representing vets practicing in the state, are automatically eligible for credit. And it is possible to form an organization affiliated with the CVMA and have voting rights in the CVMA house of delegates with the signatures of only 25 CVMA members. So a group of veterinarians interested in pseudoscientific medicine, such as homeopathy, can form an organization, become affiliated with the CVMA, and then offer continuing education courses. And since many other states recognize the approval of the California Veterinary Medical Board, these credits can be used by veterinarians around the country. Here’s how the AHVMA materials describe the process:

In California, there is already a process in place to form a new organization that is recognized by the state association. In order to be able to present continuing education that the state of California will offer credits for, an association must be a member of the California Veterinary Medical Association (CVMA) House of Delegates. Those who sign the petition must be members of the CVMA. The CVMA does not care how many non-CVMA members are included in the organization, as long as they have 25 CVMA members to start the organization, and maintain 20 CVMA members once the organization is accepted….

In 2011, the AHVMA meeting will be in California and co-hosted by the California Holistic Veterinary Medical Association (CHVMA). Because the CHVMA is a member of the California Veterinary Medical Association House of Delegates (CVMA HOD), and all CVMA CE is approved by the state of California, this means next year’s meeting is approved by the California State Board of Veterinary Medicine for CE credits for all lectures. Most states have reciprocity with the state of California. As long as your state has reciprocity with California, they will accept these lectures for CE credit.

According to the president of the Academy of Veterinary Homeopathy, the AHVMA is attempting to pursue this same strategy nationally by getting the AHVMA recognized in the American Veterinary Medical Association (AVMA) house of delegates:

AHVMA has been trying to become a voting member of the AVMA House of Delegates. It is important that AHVMA has enough AVMA members to meet the requirements of membership.

Once AHVMA becomes a member of the House of Delegates, AVH RACE CE is also automatically approved since we are, essentially, part of AHVMA as an Allied Group.

Through processes such as these, the legitimacy of medical approaches is established not on the basis of scientific evidence, but through the political lobbying efforts of a minority of practitioners who believe in such approaches regardless of the evidence, and through the apathy and desire not to offend or engage in controversial debate of the silent majority who do not use such therapies. Of course, all human social institutions rely on politics to solve disputes without violence, and certainly this is appropriate. Unfortunately, when there are clear right or wrong answers in such dispute unequivocally established by objective scientific means, it is unfortunate that such mechanisms can be used to make an end run around the truth and promote failed ideas that science and reason would require us to abandon. It is certainly not in the interests of our patients or our profession to have homeopathy, Earth Acupuncture and other similar nonsense gain legitimacy as medical therapies by popular vote regardless of the underlying facts about such therapies. One can hope that enough people within veterinary organizations such as the AVMA and CVMA will recognize that politics and belief is on the verge of triumphing over truth and will object, but I fear such hope will prove unfounded.

Posted in General, Law, Regulation, and Politics | 29 Comments

Dr. Andrew Jones: Selling “Secrets” and Lies finally has a price

Posted on November 18, 2010 by skeptvet

I once referred briefly to Dr. Andrew Jones in a previous post as an example of one of the warning signs of quackery, the claim of secret knowledge that mainstream science and medicine doesn’t want you to have. Of course, his marketing activities include lots of other characteristic features of alternative medicine propaganda, including unfounded accusations about the harm done by conventional medicine and unproven or outright false claims about the safety and efficacy of alternative methods. In many ways, he is a fine example of many warning signs of quackery.

It turns out, the veterinary medical licensing authorities in Canada, where Dr. Jones lives, have more backbone than most of those in the U.S., and for years they have been warning Dr. Jones that unfairly denigrating his colleagues and making false claims is unprofessional and incompatible with the standards licensed veterinarians are expected to uphold. He repeatedly claimed he would abide by the marketing and advertising guidelines all other veterinarians are subject to in his jurisdiction, and repeated broke those commitments. Finally, the British Columbia Veterinary Medical Association (BCVMA)  imposed significant fines, and Dr. Jones has chosen to give up his license so he can market his veterinary self-help products without interference.

His supporters, of course, are trying to paint him as a victim, but the evidence is clear that he is yet another alternative guru with a messiah complex making money not only off peddling ineffective or unproven remedies but discouraging pet owners from seeking real medical care for their pets.

The details of the proceedings against Dr. Jones are included in the BCVMA reports available here:

BCVMA Investigating Committee Report

College of Veterinarians Council Final Decision

(note-these links are no longer working. For now, the ruling can be found here)

In 2003, 2004, and 2005, Dr. Jones was asked to stop using advertising language for his practice and products that implied he provided better care or was less concerned about money than other veterinarians. He advertised his own services as “affordable” and “superior” compared to other vets and said things like:

“You will find us honest, convenient, affordable, and above all caring”

“We use only the best materials and labs”

Some of this language was relatively innocuous, and his supporters have made a point of this to suggest that there is no real issue but competition and professional jealousy here. However, it should be obvious why advertising oneself as better than ones colleagues, especially with no evidence but that of one’s own ego to support such a claim, is both offensive and unprofessional. In any case, the only sanction imposed on Dr. Jones was to stop using such language, which he repeatedly agreed in writing to do. As we shall see, he not only broke these promises but engaged in far more egregiously inappropriate behavior.

Dr. Jones went on to form “Dr. Jones Inner Circle Forum,” a web-based service which charged pet owners a subscription fee to receive his “secret” knowledge and wisdom that he repeatedly claimed would make most visits to the veterinarian unnecessary. On this forum, he repeatedly accused conventional veterinarians of naked greed and a lack of interest in the well-being of their patients:

1) P.P.S My goal is to give you the most up to date, unbiased dog and cat health information to allow YOU to keep your pet in top health. I want you to be an empowered pet owner, and You will be one as part of my exclusive Dr. Andrew Jones’ Inner Circle. [I can’t help notice that hucksters and quacks have a great fondness for CAPITAL LETERS. I wonder why that is…]

2) At the end of the day it boils down to money. If the public are not lining vets pockets with unnecessary visits, purchasing processed foods from which vets also take a percentage, that’s quite a reduction in income.

3) I am “positive” that many ‘conventional” veterinarians think that Veterinary Secrets Revealed is a bunch of “hocus pocus” and should be shut down.

What does this mean?

It means that other veterinarians are upset about my website, ebook, and Complete Home Study Course.

After all, I’m showing people how to treat their own pets and save money on Vet bills [at least some of the money they save, of course, will go to Dr. Jones]

4) You should check out my Complete Home Study Multimedia Course. I guarantee that you will treat your pet’s illness and ailments confidently, competently and for less than it would cost if you relied exclusively on professional Veterinary services.

5) This issue: The 6th Secret – The 6th key to extending your pet’s life is knowing when to AVOID you Veterinarian.

In his posts on the Inner Circle forum, Dr. Jones repeatedly claimed alternative or “holistic” methods were safer and more effective than scientific medicine and that the only reason that conventional veterinarians object to them is that the “Secret Society of Veterinarians” was afraid they would lose money if people learned how to keep their pets healthy without professional medical care. When challenged for proof of his claims, Dr. Jones resorted to the time-worn and thoroughly meaningless arguments of longevity, popularity, and personal experience or anecdote:

‘There is no proof…’

But how do you think that most animals in the world are treated? It’s with natural medicine…

Most people in India or China can’t afford to even see a vet or buy medication.

They use herbs, acupressure, massage, supplements, homeopathic treatments.

The animals get better, because the treatments work.

I have seen thousands of pets recover with home remedies.

That is proof.

As if we are seriously expected to believe that the cats and dogs in the third world who do not have access to real veterinary care are healthier than the pets in the developed world. Just like the people who are too poor to have access to science-based medicine are healthier than those of us in the developed world, despite the minor problems of high infant mortality, low life-expectancy, and rampant infectious and parasitic diseases most of us have never seen, I suppose? Arrant nonsense.

The list of absurd, untrue, and unprofessional accusations and claims, all made in an effort to sell books, videos, and subscriptions to the “secrets” of his “Inner Circle,” is extensive. Here are just a few examples:

1) I firmly believe in holistic medicine for pets.

We are killing them with the most of the terrible dog foods on the market along with pesticides contained in flea and tick medications and also medicines the vets want you to purchase. [a letter supposedly from a reader that Dr. Jones reprinted  because it reflected his views]

2) “…you should be leery of any LARGE pet food manufacturer- they re[sic] in the business to profit first”

3) HERBAL THERAPY. A number of herbs are used in diabetes. These include Gymnema, Bitter Melon, Fenugreek, and Ginseng. These herbs can be found in specific diabetic herbal combinations. Ginseng is the most effective of these herbs. It has been shown to lower blood sugar in people, and is believed to do the same in animals. The dose is 30 mg per lb of body weight twice daily of the dried herb, or 1 drop per pound of body weight twice daily of the tincture.[implying people can treat their pet’s diabetes alone, with unproven herbal remedies, is especially egregious because it will undoubtedly lead to suffering and death for animals with this serious disease who are not properly treated]

4) Pay Close Attention – today, I’m going to show you why conventional veterinary medicine is harming your pet and step-by-step what you must do to prevent it.

“Regular” veterinary care has lost it’s [sic] effectiveness over the years, and in some cases is causing illness in our pets.

5) The entire Pet Health Industry has a vested interest in discrediting alternative medicines which can safely, naturally and effectively allow pet owners to care for thei pets at home. [a nice example of the conspiracy-theory aspect of quackery]

6) Most veterinarians just choose to ignore the research because either they still feel the benefits of vaccines outweigh the risks, or that they don’t want to lose income from giving booster shots to all those animals each year.

Apart from such false and unproven accusations and claims, Dr. Jones engaged in inappropriate hucksterism, offering “money-back guarantees” and “cures” when such claims can never be anything but lies in medicine.

Despite all of this, the licensing board did not intend to drive Dr. Jones out of practice. He was fined substantially, both for the numerous violations of ethics laws and, even more importantly, for acknowledging in writing that he understood and intended to abide by them and then reneging on these promises in order to continue to profit from unethical and deceitful advertising. However, when he offered to give up his license, the board specifically indicated it did not consider this an appropriate or necessary punishment for the violations. Dr. Jones decision to give up his license is entirely his own.

Unfortunately, it is likely he will continue to profit from spreading lies and misinformation about the veterinary profession, and from offering dangerous advice and unproven or false treatments. He will have to walk a fine line since without a license he cannot legally practice veterinary medicine, but of course the benefits of a free society are great enough that he must be allowed to spout his nonsense as long as he does not cross the line into liable, slander, or the practice of medicine. Sadly, it wouldn’t surprise me at all if he ends up in the U.S. where regulatory authorities have proven far less willing to challenge such snake oil salesman taking advantage of pet owners and profiting from fear and ignorance.

Posted in General, Law, Regulation, and Politics | 199 Comments

Encouraging studies on probiotics for canine diarrhea

Posted on November 17, 2010 by skeptvet

I have written about probiotics previously (in general, for herpsvirus in cats, and some of the overhyping and quackery associated with them), and in general I have been cautiously optimistic about their potential, while criticizing claims that go beyond the data. I recently came across a couple of studies which illustrates some of the good positive research on probiotics and makes me more inclined to consider using them for specific conditions.

First Study

Kelley RL, Minikhiem D, Kiely B, O’Mahony L, O’Sullivan D, Boileau T, Park JS. Clinical benefits of probiotic canine-derived Bifidobacterium animalis strain AHC7 in dogs with acute idiopathic diarrhea. Veterinary Therapeutics 2009 Fall;10(3):121-30.

The first study is the better of the two for several reasons. The probiotic chosen was a strain of Bifidobacterium derived from dogs. One of the problems with the generally application of probiotics is the questionable logic of taking small amounts of an organism that does not normally live in the gut of a given species and cannot colonize it and giving this organism to “balance” the animal’s gut flora. Commensual organisms that already live in the gut, and which presumably share a history of mutual adaptation with the host, seem more likely to be beneficial in restoring a disturbed GI ecology. Previous research had been done to show this strain was able to survive passage through the stomach acid and colonize the intestine of the dog as well as to survive the processing and storage conditions used to create a product that can be shipped, stored, and given to patients. This groundwork greatly increases the plausibility of the intervention.

The subjects in this study all had acute diarrhea, and in most cases it was idiopathic, meaning no specific cause was found. This is the most common kind of diarrhea seen in clinical practice, and it usually gets better on its own within a week or so. The goal of the study, then, was to see if the probiotic helped dogs to get better sooner than those not treated at all. This, of course, is a valuable goal, but we must be careful not to confuse this use with treatment of diarrhea that is not self-limiting and might not get better without therapy, which is an entirely different problem and for which the value of probiotics would have to be demonstrated in a study specifically conducted for that purpose. Over-generalizing is a common error behind the use of novel or alternative therapies, and it is vital to remember that if a treatment is effective for, say acute self-limiting diarrhea, that doesn’t mean it is effective for chronic diarrhea, parasitic or infectious diarrhea, food allergy diarrhea, or any other different kind of diarrheal disease.

In this study, 31 dogs with were randomly assigned to receive either the probiotic or a matched placebo. All personnel involved in care and evaluation of the subjects were blinded to the treatment groups. All dogs were screened for parasites. 3 were found to have Giardia, and I was initially concerned that if these dogs had more severe disease and happened to be in the placebo group, they might create the false impression of a better outcome for the treatment group. I contacted the manufacturer of the product who contacted the lead author to inquire about this possibility. I was informed that 2 of these dogs were in the placebo group and 1 in the treatment group. These 3 subjects were analyzed to see if their symptoms were worse than the others (they were not) and when their results were removed from the analysis it did not change the outcome.

All the dogs were young (between 1 and 2 years of age) and residents of a guide dog colony. This allows for better control of variables such as diet, environment, breed, age, concurrent diseases and medications and so on. It also might make the results less applicable to other populations, but such are the tradeoffs of all research studies.

Some of the subjects in both groups received the anti-diarrhea antibiotic metronidazole. There were more dogs medicated in the control group than in the probiotic group. The authors acknowledge this is a weakness in the study, but the trend of the results was unchanged when the cases receiving this drug were excluded from the analysis (though this did not leave enough animals to make statistical comparisons).

For dogs in the placebo group their diarrhea resolved in an average of 6.6 days. The dogs in the probiotic group returned to having normal stools in an average of 3.9 days, and this difference was not due to chance alone based on the statistical analysis. This is enough of an effect that if it is consistent in other patient populations and circumstances, it would be a meaningful clinical benefit. Overall, this study provides good evidence for the benefit of this particular probiotic in acute, self-limiting, idiopathic diarrhea in dogs. Again, we must not assume this means that all probiotics are beneficial for all kinds of diarrhea in all patient populations.

Second Study

Herstad HK, Nesheim BB, L’Abée-Lund T, Larsen S, Skancke E. Effects of a probiotic intervention in acute canine gastroenteritis–a controlled clinical trial. J Small Anim Pract. 2010 Jan;51(1):34-8.

This study involves a slightly more realistic, and thus not as well controlled, patient population and treatment and monitoring system. There are also a few other problems with methodology that make this a weaker study.

The probiotic used was a mixture of 5 different organisms, some from pigs, soil, humans, and unknown origin. It is unclear from the paper what if any prior basic research was done to establish whether these organisms survive processing, storage, and stomach passage and if they can colonize the intestines of dogs. No attempt was made in this study to see if the probiotic had colonized the subjects.

36 dogs with diarrhea (22 of which also had vomiting) were seen at a single hospital and randomly assigned to the probiotic or placebo groups. Many were screened for bacterial or parasitic causes of diarrhea, but not all. The assessment of improvement was owner evaluation of when the last abnormal stool and the first normal stool occurred. This potentially introduces some question about the reliability of these outcome measures, though it is unlikely there would be a systematic error favoring one or other treatment group. The subjects in the probiotic group had had symptoms slightly longer than those in the placebo group before entering the study, though this difference was not statistically significant.

The time from start of treatment to the last abnormal stool was an average of 1.3 days in the probiotic group and 2.2 days in the placebo group. This difference barely reached statistical significance (P=0.45). The difference of 1 day in duration of symptoms might be clinically meaningful, though less so than the difference seen in the first study.

The time to resolution of diarrhea was shorter than in the previous study, but this was for dogs who did not start treatment until they had symptoms for an average of 2-3 days, unlike the other study in which dogs with diarrhea were identified and began treatment immediately because they were residents in a colony with professional caretakers. If you count the time from onset of symptoms to end of symptoms, it was 6.1 days for placebo the group and 4.1 days for the probiotic group in this study, compared with6.6 for placebo and 3.9 for probiotic in the first study.

The other main measures looked at (time from start of treatment to first normal stool, number of stools, and duration of vomiting), there were no differences between the placebo and probiotic groups. Overall, then, this study found 1 marginally significant difference between probiotic-treated and placebo-treated dogs out of 4 outcome measures, which is a pretty weak showing.

Conclusion

So these studies do provide some support for the potential benefits of probiotics for acute, self-limiting diarrhea in otherwise healthy dogs. The better of the two studies provides pretty good quality evidence for this use, though more work will have to be done to see if these results are confirmed in other populations and more real-world circumstances. The second study provided a hint of an effect, but the results were weak and not particularly convincing.

I’m inclined to agree with the authors of the first study that a product derived from normal dog intestinal flora and adequately studied to determine that it is viable through processing, shipping, storage, and passage through the stomach is more likely to have a meaningful benefit than other products, and I would be willing to recommend using this product for acute, self-limiting diarrhea pending further research to either confirm or challenge the limited results we currently have.

Overall, I’m still cautiously optimistic about probiotics, at least for acute, self-limiting diarrhea, and these studies encourage that optimism. Clearly, there is much more work to be done to define which organisms in what doses will benefit which patients, but as long as we are careful not to imagine these products as some kind of panacea and go beyond the available data, they seem to be reaching a point where judicious clinical use is reasonable.

Posted in Science-Based Veterinary Medicine | Leave a comment

PetDiets.Com: An excellent source for science-based pet nutrition information

Posted on November 14, 2010 by skeptvet

I just wanted to point out a web site I found recently which offers excellent information on pet nutrition. PetDiets.com is the site of Veterinary Nutritional Consultations, Inc. (VNC). This organization is a independent consulting group that provides nutrition information for veterinarians and for pet owners. It is run by Dr. Rebecca Remillard, a board-certified veterinary nutritionist.

For clients interested in feeding a homemade diet, I always recommend consulting a veterinary nutritionist. Homemade diets can be an excellent feeding option, but they are notorious for being nutritionally inadequate (1), and the advice of a nutritionist can help pet owners avoid unintentionally feeding inappropriate diets.

I also like the extensive collection of pet owner questions Dr. Remillard has answered and posted on her site. She provides clear, comprehensive, and science-based answers to hundreds of questions regarding homemade and commercial diets, nutritional supplements, and other nutrition-related topics.

References

1. Lauren , S.,  et al, Computer analysis of nutrient sufficiency of published home-cooked diets for dogs and cats. Proc ACVIM Forum 2005.

Posted in Nutrition, Science-Based Veterinary Medicine | 12 Comments

CAM and the Law Part 2: Licensure and Scope of Practice Law

Posted on November 11, 2010 by skeptvet

This is a cross-post from Science-Based Medicine- CAM and the Law Part 2: Licensure and Scope of Practice Law

This post is intended to illustrate a bit about how medicine, including alternative medicine, is defined and limited legally by state licensure. This is, of course, an enormous topic, especially given the variety of laws and regulations among the 50 states and District of Columbia, and the many, often mutually inconsistent, court decisions interpreting them. A comprehensive survey would resemble Gibbon’s history of Rome and would likely be out-of-date the moment it was finished. My more modest goal here is to highlight a few of the ways in which licensure and scope of practice laws intersect the practice of CAM and give a few representative examples. 

The Rise of Medical Licensure

In the 19th century, a bewildering variety of different approaches to maintaining health and treating disease competed for the trust, and dollars, of prospective patients (or their owners, in the case of animal patients). Caveat emptor was the rule in an unregulated medical marketplace. Mainstream medicine was a competitor in this marketplace, though it was hardly science-based to any great extent compared to conventional medical practices today. Homeopathy was another pretty big player, along with osteopathy and numerous other more or less organized schools, as well as many individual snake oil salesmen, faith healers, local providers of folk remedies, and so on.1,2

Throughout the 19th and early 20th centuries, state legislatures passed medical practice acts defining the practice of medicine, the criteria for medical licensure, and the criminal penalties for the unlicensed practice of medicine. The American Medical Association, founded in 1846, played a powerful role in driving and shaping these early enactments of the state police authority to regulate medicine. The AMA-sponsored Flexner Report on medical education released in 1910 did much to shape the criteria states used to award licensure, and thus to shape the content of accepted medical practices. Veterinary medicine lagged a bit behind in this initial licensure movement, with California apparently being the first state to license vets in 1893, but the general legal trend has been much the same as for regulation of human medicine.1,3

What is the Practice of Medicine?

There is some variation in the details of how the practice of medicine is defined in different state practice acts, but all the definitions are quite broad. They give physicians great latitude in the therapies they provide, but  they also leave some uncertainty as to what actually constitutes practicing medicine, and there is room for the courts to interpret and clarify the law.

In New York, for example, the law reads:

The practice of medicine is defined as diagnosing, treating, operating or prescribing for any human disease, pain, injury, deformity or physical condition.4

In California, the definition is even broader:

[A]ny person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state,  or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person…5

State veterinary practices acts are also very broad, sometimes even more so than medical practice acts. For example, in California:

A person practices veterinary medicine, surgery, and dentistry, and the various branches thereof, when he or she does any of the following:
(a) Represents himself or herself as engaged in the practice of veterinary medicine, veterinary surgery, or veterinary dentistry in any of its branches.
(b) Diagnoses or prescribes a drug, medicine, appliance, application, or treatment of whatever nature for the prevention, cure or relief of a wound, fracture, bodily injury, or disease of animals.
(c) Administers a drug, medicine, appliance, application, or treatment of whatever nature for the prevention, cure, or relief of a wound, fracture, bodily injury, or disease of animals…
(d) Performs a surgical or dental operation upon an animal.
(e) Performs any manual procedure for the diagnosis or pregnancy, sterility, or infertility upon livestock or Equidae.
(f) Uses any words, letters or titles in such connection or under such circumstances as to induce the belief that the person using them is engaged in the practice of veterinary medicine…6

With such general legal language, it might seem that physicians and veterinarians could do almost anything and call it practicing medicine. And it might also seem dangerous for people who are not licensed to practice medicine to do anything at all to a sick person or animal for fear of violating their state’s medical practice act. However, the states and the courts have created numerous exceptions and limitations to these very general standards. 

Some common exceptions are quite sensible and obvious. For example, nurses and other healthcare providers working under physician supervision, physicians working for federal agencies, properly supervised students, lay people providing reasonable first aid or lifesaving care or using widely accepted over-the-counter remedies, and many other similar activities are defined as legitimate and not the unlawful practice of medicine.1 

Other exceptions are sometimes less obvious, and they may provide loopholes for alternative medical providers to ply their trades. For example, animals are considered property, not persons, under the law, so their owners and anyone they authorize can do almost anything they like to treat them, within only the limitations of animal cruelty laws, which have very high standards of proof and lax enforcement.3 Some states, such as California, also provide other specific exemptions, such as this one:

Nothing in this chapter [the Medical Practice Act] shall.…regulate, prohibit, or apply to any kind of treatment by prayer, nor interfere in any way with the practice of religion.7

In addition to defining the practice of medicine, the state practice acts also define the criteria required to obtain and maintain a medical license. These often include graduation from an approved educational program with coverage of specified subject matter, practical clinical training, a passing score on licensing examinations, and ongoing professional education. In the early days of medical licensure, it was the development of these criteria that had the greatest impact in terms of promoting scientific medicine and limiting the ability of practitioners of alternative approaches to continuing practicing their forms of medicine. 

Licensure of Non-Physicians

In addition to physicians, states also license a number of other medical professions, including providers of alternative therapies. The relevant legislative acts define the scope of practice and criteria for licensure for these providers just as they do for physicians and veterinarians, though the scope of acceptable activities is often far more limited and narrowly defined. 

The major CAM methods are the most commonly licensed. Chiropractors are licensed in all 50 states, non-M.D. acupuncturists are licensed in 37 states, naturopaths are licensed in 17 states (though they are specifically prohibited from practicing in 2 states), and “homeopathic physicians” are licensed in 3 states.8 States that do not license such providers do sometimes still explicitly regulate the more common alternative methods, such as acupuncture, within other health or professions statues. 

Laws licensing alternative therapists are often very specific, while still leaving a surprising amount of room for subsequent interpretation and controversy. In California, for example, the Acupuncture Licensure Act defines acupuncture directly while also managing to fit in a much broader ideological statement:

In its concern with the need to eliminate the fundamental causes of illness, not simply to remove symptoms, and with the need to treat the whole person, the Legislature intends to establish in this article, a framework for the practice of the art and science of Asian medicine through acupuncture…

“Acupuncture” means the stimulation of a certain point or points on or near the surface of the body by the insertion of needles to prevent or modify the perception of pain or to normalize physiological functions, including pain control, for the treatment of certain diseases or dysfunctions of the body and includes the techniques of electroacupuncture, cupping, and moxibustion.9

The relevant legislation in California concerning chiropractic licensure defines the scope of practice for chiropractors very specifically:

(1) A duly licensed chiropractor may manipulate and adjust the spinal column and other joints of the human body and in the process thereof a chiropractor may manipulate the muscle and connective tissue related thereto. 

(2) As part of a course of chiropractic treatment, a duly licensed chiropractor may use all necessary mechanical, hygienic, and sanitary measures incident to the care of the body, including, but not limited to, air, cold, diet, exercise, heat, light, massage, physical culture, rest, ultrasound, water, and physical therapy techniques in the course of chiropractic manipulations and/or adjustments. 

(3) Other than as explicitly set forth….a duly licensed chiropractor may treat any condition, disease, or injury in any patient, including a pregnant woman, and may diagnose, so long as such treatment or diagnosis is done in a manner consistent with chiropractic methods and techniques and so long as such methods and treatment do not constitute the practice of medicine by exceeding the legal scope of chiropractic practice as set forth in this section. 

(4) A chiropractic license issued in the State of California does not authorize the holder thereof: 
(A) to practice surgery or to sever or penetrate tissues of human beings, including, but not limited to severing the umbilical cord; 
(B) to deliver a human child or practice obstetrics; 
(C) to practice dentistry; 
(D) to practice optometry; 
(E) to use any drug or medicine included in materia medica; 
(F) to use a lithotripter; 
(G) to use ultrasound on a fetus for either diagnostic or treatment purposes; or 
(H) to perform a mammography.

(5) A duly licensed chiropractor may employ the use of vitamins, food supplements, foods for special dietary use, or proprietary medicines, if the above substances are also included in section 4057 of the Business and Professions Code, so long as such substances are not included in materia medica as defined in section 13 of the Business and Professions Code…

(6) Except as specifically provided in section 302(a)(4), a duly licensed chiropractor may make use of X-ray and thermography equipment for the purposes of diagnosis but not for the purposes of treatment. A duly licensed chiropractor may make use of diagnostic ultrasound equipment for the purposes of neuromuscular skeletal diagnosis. 

(7) A duly licensed chiropractor may only practice or attempt to practice or hold himself or herself out as practicing a system of chiropractic….A chiropractor may not hold himself or herself out as being licensed as anything other than a chiropractor or as holding any other healing arts license or as practicing physical therapy or use the term “physical therapy” in advertising unless he or she holds another such license.10

The Devil in the Details

Despite the specificity of such laws and regulations, there is a fair bit of ambiguity as to exactly who is allowed to do what, and state attorneys general and the courts are frequently called upon to interpret these laws. In some states, physicians have been held to be legally permitted to practice alternative therapies even without specific licenses in those approaches, under the general provisions of medical practice. Other states, however, have required physicians to be licensed in these approaches before offering them. And, of course, given the controversial nature of many CAM therapies, physicians run some risk of being sanction for “unprofessional conduct” by their state medical board for offering some unconventional therapies. 

In one well-known example, a North Carolina doctor was disciplined by the state medical board or administering homeopathic treatments. The board concluded that since homeopathy “does not conform to the standards of acceptable and prevailing medical practice,” using it constituted unprofessional conduct. After this sanction was reversed by two lower courts (one asserting there was not sufficient evidence to support the board’s conclusions about homeopathy, and the other arguing that it didn’t matter because homeopathy was harmless), the state supreme court upheld the board’s decision.11

The majority argued, quite sensibly, that “a general risk of endangering the public is inherent in any practices which fail to conform to the standards of ‘acceptable and prevailing’ medical practice” regardless of whether the specific treatment was directly harmful. The justices also recognized that “certain aspects of regulating the medical profession plainly require expertise beyond that of a layman” and that “while questions as to the efficacy of homeopathy….may be open to debate among members of the medical profession….the courts are not the proper forum for that debate.”12 

Unfortunately, the legislature of North Carolina took a different view, preferring to protect consumer choice and the autonomy of individual providers, and the law was subsequently amended to specifically protect physicians who offer treatments that are “experimental, nontraditional, or that [depart] from acceptable and prevailing medical practices” unless they can be clearly shown to be more harmful than conventional treatments.12

A variety of legal opinions and rulings also exist that clarify (or sometimes obscure) the limits of acceptable therapies licensed alternative practitioners can provide as well. For example, in some states chiropractors can legally provide colonic irrigation, perform pelvic and rectal exams, perform electrocardiograms, provide herbal remedies or nutritional supplements, or perform acupuncture under generous interpretations of the definition of chiropractic.13 However, other states have ruled it a violation of their scope of practice limitations for chiropractors to utilize herbal or nutritional substances in treating patients, perform pelvic exams, perform or order diagnostic blood or urine tests, and engage in other such practices deemed outside of their licensed activities.13 There are similar inconsistencies in the interpretation of what therapies are permissible for other licensed alternative providers as well.

Faith Healing and Secular Spiritual Practices

A particularly interesting area of medical jurisprudence is the relationship of licensing laws to spiritual and religious practices. The tension between individual liberty and freedom of economic activity on the one hand and the role of government in protecting the public health on the other is weak tea compared to the conflict between government police powers and the legal and cultural imperatives in the U.S. to protect religious freedom. Religion may be specifically excluded from medical regulation, as in the California code above or in states like Minnesota and Ohio, which specifically exempt Christian Science faith healing from the definition of medical practice for example.14 And even in the absence of specific exemptions for religious activity, medical regulations are often required to meet a very high standard of justification if they are perceived to interfere with religious practices. The decisions made by courts and state legislatures on such matters often hinge more on the issue of religious liberty versus state police powers than on the question of whether spiritual healing practices have any medical benefit.

This controversy also has implications for so-called “secular spiritual” approaches, such as the various energy therapies like Reiki, Thought Field Therapy, Healing Touch, some meditation or mind-body therapies, and so on. Are such methods the practice of medicine? Are they religious practices and so protected to some extent from regulation? Does it matter if they work? Or if they are harmless? These are questions that have been raised by advocates of these approaches and legal scholars but which have not often been directly or clearly addressed in law or judicial rulings.

In cases involving ostensibly religious healing practices, courts have both supported and overruled restrictions imposed by medical regulations. In one Florida case, a man who claimed to heal through prayer and laying on hands was accused of practicing medicine. He claimed his activity was protected under the provision indicating the state practice act did not apply to “the practice of the religious tenets of any church.” The state supreme court ruling in the defendant’s favor did point out that his actions did not “invade the province of the medical profession and assume the ability to diagnose diseases and prescribe drugs or other medical or surgical or mechanical means to restore the health” of his clients. However, the bulk of the opinion was concerned with the issue of religious liberty and with the apparent lack of any direct harm done by the healing practice, as well as the more general epistemological argument that science doesn’t know everything:

…from ancient times down to this modern and so called materialistic age, there have always been quite a large percentage of people who believed in the efficacy and availability of Divine power, not only to save the souls but also the bodies and lives of men and to heal all the ills that flesh is heir to….And if this class of people hear and believe that some person can and does invoke the power of Most High to heal people of their ills, or that in his own person such individual possesses some strange mental, magnetic or psychic power to banish disease from the human body….[they] will seek him out. And it is not the policy of our laws to prevent them; nor to punish those to whom they go, and who endeavor to heal the ills of men by such mental or spiritual means…

The reason for this policy is founded upon the liberty of the individual citizen under our bill of rights, and the fact that so long as these faith healers or spirit mediums rely upon their power, by prayer or faith, to invoke the exercise of the power of the Almighty, if indeed they fail to cure, they at least can do no harm…

Now this appellant testified that the power which he invoked was not his own, but that it was the power of God. And if some of the uncontradicted witnesses are to be believed, he was instrumental in accomplishing some remarkable cures….Now, to most of us, this matter of healing ‘by faith and the laying on of hands,’ ancient as it is, is still beyond us. But according to Shakespeare’s Hamlet, ‘There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.’ And in that magnificent speech of St. Paul’s before King Agrippa, he said to the king: ‘Why shuld it be thought a thing incredible with you, that God should raise the dead?’ So the legislature and the courts might well accord our citizens the liberty to decide such questions as these for themselves.”15

Other rulings on the question of whether religious practices are subject to the regulations that govern the practice of medicine have been more pragmatic and less prolix. A California case concerned a healer who imposed on people not only prayer and laying on of hands but strict fasting and dietary requirements and a prohibition on conventional medical diagnostics or treatment. He attempted to defend his practices as religious rather than medical, even after the death of one person and significant injury to others following his approach. Despite the state’s exemption of religious practices from the medical practice act, the court ruled that the methods used went well beyond protected religious activity and invaded the domain of secular medicine. 

There is no question that the described activities constitute the practice of medicine; that the Board has a substantial interest in preventing such activities, which are demonstrably harmful on this record; …[and] there is [no] serious argument made that the injunction infringes appellants’ constitutional rights of free exercise of religion under the First Amendment. Cases are legion which hold that freedom of religious belief may be absolute but freedom of action is not.[citations omitted] The state may legitimately regulate dangerous conduct regardless of religious content. It is therefore universally held that in the interest of protecting its citizens’ health, the state may regulate health treatments which are potentially dangerous to the patient….In reaching this decision we do not deem it necessary to question the bona fides of appellant Andrews’ religious faith; that fact is not relevant…16

Of course, there are salient differences in the facts in these cases, as well as the historical moments in which they were heard. The practical question of whether direct harm is done by a spiritual healing approach is weighed by the courts in adjudicating such cases. However, as is frequently the case, the reasoning that informs the courts’ decisions often fail to address the scientific question of the efficacy of such treatments or the potential indirect harm they may do in discouraging effective medical care. And the issues of individual and religious liberty are often given as much or more weight than the question of whether the interventions are demonstrably effective or not.

Is Medical Licensure Fair and Does It Protect the Public?

Medical licensure is widely accepted as a legitimate use of state authority to protect the public health by preventing people from being exposed to dangerous and ineffective therapies in an unrestrained medical market. Proponents of CAM, as well as opponents of government regulation generally, sometimes cast the promulgation of medical licensing laws as a straightforward protectionist campaign by “allopathic” doctors to wipe out the competition. While it would be disingenuous to suggest that professional organizations such as the AMA or the American Veterinary Medical Association (AVMA) have no political or economic agendas beyond the protection of the public good, it is a convenient but inaccurate exaggeration to say that concerns for territory or income have been the prime motivators of efforts to license and regulate medicine. Concerns for the actual, verifiable scientific truth behind medical practices and the welfare of patients have always been a genuine and important reason for encouraging government to regulate healthcare. 

Even in the notorious antitrust case Wilk v. American Medical Association, in which chiropractors succeeded in using anti-trust laws and allegations of protectionism to weaken the ability of the AMA, and other professional organizations, to marginalize unscientific medical practices, the court was “persuaded that the dominant factor [in the AMA’s efforts] was patient care and the AMA’s subjective belief that chiropractic was not in the best interests of patients.”17

Licensure and scope of practice limitations do leave enormous room for physicians and others to engage in ineffective and dangerous medical practices, and the spirit and letter of the law is subject to wide-ranging interpretations in different states and courts. And while licensing CAM professions arguably gives the state some ability to enforce reasonable standards of training and practice, there is an element of Tooth Fairy Regulation in this (with apologies to Dr. Hall). 

For example, the California law regulating acupuncturists requires a minimum of 2250 hours of clinical training and 1548 hours of theoretical and didactic training to apply for a license. Some of this, such as how to avoid transmitting infectious diseases with needles, is legitimate training that protects public health. But it is debatable how helpful it is to require many hours of study of Qi Gong, Traditional Oriental Medicine Theory, Moxibustion, Ear Acupuncture theory, and so on.
And, of course, licensure creates a perception of legitimacy and accuracy to the claims of CAM providers in the minds of the public, who generally don’t appreciate the extent to which decisions about medical regulation are made less on the basis of scientific facts than on the basis of political and philosophical issues. 

On balance, the regulation of conventional medical practice, and to a lesser extent alternative therapies, probably is reasonably effective in protecting the public. The popularity and availability of dangerous and clearly ineffective approaches is certainly less than it was during the age of medical anarchism, and such laws have doubtless played a role in this. 

Why We Should Understand Medical Licensing Laws

While we must always maintain our emphasis on verifiable scientific facts about the safety and efficacy of proposed therapeutic approaches, those of us dedicated to science-based medicine may also be able to play a role as a constituency in shaping the writing and interpretation of medical laws and regulation to better protect the public. And we must certainly be aware of what our own state’s laws are, and participate in seeing that they are properly executed. 

In researching this subject, for example, I became aware that the California veterinary practice act has very strict requirements for veterinary supervision of chiropractic applied to animals, and also a requirement that “the veterinarian shall obtain as part of the patient’s permanent record, a signed acknowledgment from the owner of the patient or his or her authorized representative that [musculoskeletal manipulation] is considered to be an alternative (nonstandard) veterinary therapy.”18 I am certain most of the vets I know who refer patients for chiropractic treatment do not comply with these guidelines, and if wider compliance can be achieved it would likely reduce the utilization and potential harm of this unproven, and possibly dangerous, therapeutic approach. 

A familiarity with the laws govern medical practice is an important element in advocating for good quality scientific medicine and discouraging unproven or unsafe interventions. Part of my goal in this series is to encourage such familiarity. The references I cite in these posts are a good starting point, though they have their limitations and biases. Most relevant state laws and regulations are easily accessible on the internet. 

Proponents of alternative therapies are aware of the importance of understanding and helping to shape medical laws and regulations, and they explicitly encourage CAM practitioners to be knowledgeable and involved (see, for example,  these resources for acupuncturists, naturopaths, and chiropractors). Since professional organizations such as the AMA and AVMA are limited by political and legal considerations from aggressively working to shape legislation and public policies that discourage alternative therapies, those of us who would promote science-based medicine would do well to be as familiar with medical laws and the agendas that influence them as we try to be with the scientific facts concerning questionable medical practices. 

References

  1. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010.  Return to text.
  2. Ramey DW, Rollin BE. Untested therapies and medical anarchism. In: Complementary and alternative veterinary medicine considered. Ames (IA), USA: Iowa State Press, 2004. p.168-9. Return to text.
  3. Wilson JF, Rollin BE, Garbe, JAL. Law and ethics of the veterinary profession.Morrisville (PA), USA: Priority Press Ltd, 1993. Return to text.
  4. N.Y. Educ. Law § 6521. Cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 36. Return to text.
  5. Cal. Bus. & Prof. Code § 2052(a). Cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 36. Return to text.
  6. Cal. Bus. & Prof. Code § 4826. Cited In: California Veterinary Medicine Practice Act. 2010 Ed. Charlottesville (VA), USA: LexisNexis, Matthew Bender & Company, Inc, 2010. p. 5-6. Return to text.
  7. Cal. Bus. & Prof. Code § 2063. Retrieved Sept. 9, 2010 from California Law Website: http://www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=02001-03000&file=2050-2079 Return to text.
  8. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.56. Return to text.
  9. Cal. Bus. & Prof. Code § 4026-4027. Retrieved Sept. 9, 2010 from California Law Website: http://www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=04001-05000&file=4925-4934.2 Return to text.
  10. Cal. Admin. Code tit. 16, § 302 Retrieved Sept. 9, 2010 from webite: http://weblinks.westlaw.com/result/default.aspx?cite=16CAADCS302&db=1000937&findtype=L&fn=%5Ftop&ifm=NotSet&pbc=4BF3FCBE&rlt=CLID%5FFQRLT2612239251299&rp=%2FSearch%2Fdefault%2Ewl&rs=WEBL10%2E08&service=Find&spa=CCR%2D1000&sr=TC&vr=2%2E0 Return to text.
  11. Guess v. Board of Medical Examiners 393 S.E.2d 833 (1990). Cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 42-44. Return to text.
  12. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.50. Return to text.
  13. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.87-88. Return to text.
  14. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.61-62. Return to text.
  15. Curley v. State of Florida Supreme Court of Florida, en Bacn 16 So. 2d 440 (1943). Cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 58-60. Return to text.
  16. Board of Medical Quality Assurance v. Arthur Andrews Court of Appeal, Sixth Distr., California 211 Cal. App. 3d 1346 (1989). Cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 60-63. Return to text.
  17. Wilk v. American Medical Association 671 F. Supp 1465 (N.D. Ill.) 1987. Cited in: Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 230-241. Return to text.
  18. Cal. Code of Regulations § 2038. Cited In: California Veterinary Medicine Practice Act. 2010 Ed. Charlottesville (VA), USA: LexisNexis, Matthew Bender & Company, Inc, 2010. p173. Return to text.
Posted in Law, Regulation, and Politics | 4 Comments

CAM and the Law Part 1: Introduction to the Issues

Posted on November 9, 2010 by skeptvet

This is a cross-post for the first in a series from Science-Based Medicine: CAM and the Law Part 1 Inroduction to the Issues

When I write or talk about the scientific evidence against particular alternative medical approaches, I am frequently asked the question, “So, if it doesn’t work, why is it legal?” Believers in CAM ask this to show that there must be something to what they are promoting or, presumably, the government wouldn’t let them sell it. And skeptics raise the question often out of sheer incredulity that anyone would be allowed to make money selling a medical therapy that doesn’t work. It turns out that the answer to this question is a complex, multilayered story involving science, history, politics, religion, and culture. 

While we science types tend to be primarily interested in what is true and what isn’t, that is a sometimes surprisingly minor factor in the process of constructing laws and regulations concerning medicine. What I hope to do in this series of essays is look at some of the major themes involved in the regulation of medical practice, particularly as they relate to alternative medicine. I will begin by touching on some of the general philosophical and legal issues that have defined the debate among the politicians and lawyers responsible for shaping the legal environment in which medicine is practiced. The I will review some of the specific domains within this environment, including: medical licensure and scope-of-practice laws; malpractice law; FDA regulation of drugs, homeopathic remedies, and dietary supplements; truth-in-advertising law; and anti-trust law.

But first…

The Disclaimer

Obviously, an exhaustive and comprehensive look at the Byzantine and unstable landscape of medical law is beyond the scope of both this blog and my own knowledge and expertise. I am no lawyer, and for the details of the laws and judicial opinions concerning this subject I must rely on sources whose accuracy I am not qualified to verify independently. Much of the published material I have found on CAM and the law seems written from a political and ideological perspective sympathetic to the postmodernist notion of multiple equally legitimate “ways of knowing,” and also to a laissez-faire approach to regulation generally. So clearly the details provided and the interpretations given in such writings may not fairly represent the legal or regulatory environment. In any case, while I hope to provide some useful insight into how CAM fits into the system of medical law and regulation in the United States,  nothing I say should be taken as the definitive word on the law or as legal advice.  

Caveat Emptor v. Caveat Venditor

There is a deep ideological divide in America on the subject of who is responsible for ensuring that the products we buy are safe and perform as advertised, and the area of medicine is not exempt from this political debate. On one extreme is the self-identified “health freedom” lobby, which argues that the consumer and the market should be the only forces to regulate healthcare products and services. As an example, economist Randall Holcombe has written:

An auto mechanic does not have to be a medical expert to use market information to find good health care, any more than a doctor has to be an automobile expert to find a good car…Deregulation not only provides incentives for patients to look for, and physicians to offer, better care, it permits all parties concerned the freedom to decide what better care is. For instance, in the debate over alternative medicine, such as herbal treatments, chiropractors, acupuncture, and so on, the question is not only whether alternative medicine is effective, but whether people should be allowed to use these alternatives even if their physical health may not improve or may even suffer….In a free country, people should be free to choose whatever health care options they want for whatever purpose…even if healthcare professionals believe that care is substandard.1

Those more sympathetic to laws and regulations intended to protect consumers from unsafe and ineffective therapies argue against this concept of “medical anarchism:”

Why not let the market decide? Why not trust the citizenry to sort out what works from what doesn’t work in medicine as we do in other aspects of life?

The answer has to do with knowledge and risk. People do let the market decide with regard to goods like ice cream cones and baseball bats, and services like travel booking. If the ice cream is not good, people won’t buy it; if the service is defective, people will go elsewhere. However, in such situations, people are easily able to evaluate the quality and value of the goods and services they receive…Nor are such services administered under duress, nor are they represented as necessary for one’s health or well-being…

But in the area of medicine, too much is at stake. If one chooses the wrong therapeutic modality, once can lose health, life, and limb. Furthermore, few individuals are sufficiently wealthy, educated, or possessed of the resources to test putative medical therapies. In fact, there are so many putative therapies, that it is impossible for an individual to try them all. When people are ill, they do not have time to test even a handful.2

These arguments tend to run in parallel, and to be only tenuously connected, with the usual focus of this blog; the question of how one evaluates medical therapies and what the evaluation indicates about safety and efficacy. Of course, many proponents of  CAM who invoke the “health freedom” position do actually believe the therapies they promote are beneficial. But the fundamental position itself does not hinge on this, since from a perspective such as Dr. Holcombe’s people should be free to choose even therapies that are ineffective or harmful without “burdensome” government regulatory interference. The self-evident notion that it is the role of government to protect the public from quackery turns out not to be self-evident to many Americans, and thus demonstrating that a given approach is quackery may not be sufficient to convince them that it should be prohibited or even officially discouraged. 

The Right to Privacy v. State Police Powers

In the legal arena, the political conflict between those favoring or opposing aggressive consumer protection regulations in the area of healthcare takes the form of statutes and judicial opinions balancing the competing constitutional principles of an individual right to privacy and a governmental authority, or even mandate, to protect the public health. Neither a right to privacy or absolute authority over one’s own body nor a government role in regulating healthcare are specifically mentioned in the U.S. Constitution, but both are held to exist by long-standing interpretation. A right to privacy, including control over one’s own body and the care of it, is generally believed to be established by a broad reading of the 14th Amendment, though there is some controversy about this as about most areas of constitutional law. The authority of the state to abrogate this right in the process of protecting the public health is usually understood to be based in the “police powers” established by the 10th Amendment.

In 1824, the Supreme Court made reference to “health laws of every description” as encompassed within the “state police powers,” those powers not specifically delegated to the federal government nor prohibited to the States which are thus held, under the Tenth Amendment, to be the prerogative of the individual states.3 The court cited and expanded this opinion in a subsequent case in 1905, in which a state mandate to protect the public health was held to override, at least in some circumstances, the individual right to control one’s own body. The case involved a man prosecuted for refusing a mandatory smallpox vaccination. The opinion stated:

The authority of the state to enact this statute is to be referred to what is commonly called the police power…this court …distinctly recognized the authority of a state to enact quarantine laws and “health laws of every description…”

The defendant insists that his liberty is invaded when the state subjects him to fine or imprisonment for neglecting or refusing to submit to vaccination…and that the execution of such a law…is nothing short of an assault upon his person. But the liberty secured by the Constitution of the United States…does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good.4

The court went on to specifically balance the “liberty secured by the 14th Amendment,” including “the control of one’s body” against “the power of the public to guard itself against imminent danger” and concluded that under at least some circumstances the authority to protect the public health trumps he right of an individual to control his or her own body. 

This precedent was further developed and expanded in subsequent cases to validate the state’s authority to define and regulate medical practices, to control what practices could be offered and by whom via licensing and scope-of-practice laws, and to prohibit individual’s from choosing specific medical treatments if these were considered to be ineffective or dangerous. I will discuss the specifics of these cases in subsequent posts. But for now I simply want to illustrate that the legal basis for the regulations of medical practice which today pertain to CAM, as well as scientific medicine, is generally seen by the courts as a balance between the individual right to privacy and the state authority to protect public health.1,5

Just the Facts, Ma’am?*

I feel it is important to emphasize again that the question of the medical facts in such cases, and how these are established, are not always seen by the courts to be as relevant as the legal or political issues. For example, in Jacobson v. Massachusetts the court specifically addressed the factual claims by the defendant that the vaccine was ineffective and unsafe. The court’s reasoning will seem familiar, and disturbing, to those of us dealing with the anti-vaccination movement today:

The appellant claims that vaccination does not tend to prevent smallpox, but tends to bring about other diseases, and that it does much harm, with no good. It must be conceded that some laymen, both learned and unlearned, and some physicians of great skill and repute, do not believe that vaccination is a preventative of smallpox. The common belief, however, is that it has a decided tendency to prevent the spread of this fearful disease…While not accepted by all, it is accepted by the mass of the people, as well as by most members of the medical profession…A common belief, like common knowledge, does not require evidence to establish its existence, but may be acted upon without proof by the legislature and the courts…The fact that the belief may be wrong, and that science may yet show it to be wrong, is not conclusive; for the legislature has the right to pass laws which, according to the common belief of the people, are adapted to prevent the spread of contagious diseases. In a free country, where the government is by the people, through their chosen representatives, practical legislation admits of no other standard of action, for what the people believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact or not. Any other basis would conflict with the spirit of the Constitution, and would sanction measures opposed to a Republican form of government.4

While the decision in this case, to support the authority of the state to enforce mandatory vaccination as a public health measure, might be welcomed by supporters of science-based public health policy, the decision itself was by no means based in science or scientific reasoning. 

The laws and judicial opinions which govern the practice of medicine may sometimes support and sometimes oppose legitimate, science and evidence-based medicine. But the legislators, lawyers, and judges responsible for these laws and opinions are not scientists, and their reasoning about scientific and medical issues often has a philosophical and epistemological basis often incompatible with the scientific approach. Such policy mistakes as DSHEA and NCCAM are much easier to understand, and hopefully prevent, if we clearly understand this.

If we are to be effective at promoting scientific medicine and containing unscientific approaches and ineffective or unsafe therapies, we must be aware of the limitations of scientific and fact-based arguments in persuading legislators and judges, as well as the general public. Though science and facts derived from scientific knowledge and investigation must be the foundation of our medical approach, they are not always the most effective means of making the case for this approach, even with our colleagues much less with the citizens, politicians, and legal professionals who ultimately control what sort of influence and oversight government has on medicine. Non-scientists tend to view debates about regulation of CAM in terms of individual rights, consumer protection, truth-in-advertising, fair competition in the marketplace, and other such political and philosophical frames which are as important, or even more important, to them as the issue of what is factually true about CAM and whether particular therapies help or harm. 

In this series of essays, I will look at laws and regulations concerning CAM primarily from these perspectives. The kinds of questions that arise in this process may initially seem odd to those of us accustomed to a straightforward emphasis on the relevant facts and evidence. Are doctors allowed to offer unproven or even clearly bogus therapies? Are they required to offer them if a patient wants them? Can a mainstream doctor, be sued for providing or failing to provide an alternative therapy? Can an alternative practitioner be sued for providing, or failing to provide, mainstream scientific medical care? Can and should patients have whatever care they want regardless of whether science supports it? And from my perspective as a veterinarian, since pets are legally property not persons, is there any legal or regulatory control over alternative veterinary medicine at all? Such questions and the reasoning behind asking and answering them, shapes the landscape within which we operate as healthcare providers and advocates for science-based medicine, so I hope an examination of them will be interesting and useful.

* Our friends at snopes.com tell me that Joe Friday never actually said this, but due to its cultural resonance I choose to invoke the phrase anyway. Oh, I hope all this exposure to legal argument and reasoning hasn’t damaged my respect for actual facts! Return to text.

References

  1. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 279. Return to text.
  2. Ramey DW, Rollin BE. Untested therapies and medical anarchism. In: Complementary and alternative veterinary medicine considered. Ames (IA), USA: Iowa State Press, 2004. p.168-9. Return to text.
  3. Gibbons v. Ogden, 22 U.S. 1, 78 (1824). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 26. Return to text.
  4. Jacobson v. Massachusetts, 197 U.S. 11 (1905). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 26-29. Return to text.
  5. Cohen MH. Legal issues in alternative medicine: A guide for clinicians, hospitals, and patients. Victoria (BC), Canada: Trafford Publishing, 2003. Return to text.
Posted in Law, Regulation, and Politics | 3 Comments

Another Homeopathy Study: Mastitis in Dairy Cows

Posted on November 5, 2010 by skeptvet

Science is ultimately an epistemological enterprise. The purpose of scientific research is to understand how things work, often with the goal of influencing them. Clinical trials in medicine aim to confirm or disprove hypotheses about diseases or medical therapies. However, no research study is perfect, and all have flaws or limitations in their methodology that casts some doubt on their findings. And even with appropriate controls and methodology, it is possible for biases and other factors to influence the results of any experiment. A real scientific truth must be robust enough to be demonstrable repeatedly and by different investigators. The balance of the evidence, and the consistency of a theory with established knowledge, not the results of any particular experiment, are the most reliable guides to what is true of false.

Ultimately, though, science is pointless if it doesn’t at some point allow us to decide that some hypotheses are true and others are false. All scientific truths may be provisional, “truth” with a small “t” as it were, but there comes a point when the evidence is strong enough that doubting an established scientific truth is unreasonable. Perhaps it is theoretically possible that previous experiments have been in error and the sun actually does circle the earth, but the evidence against this hypothesis is overwhelming that believing it is possible requires at least willful ignorance, if not outright blind faith.

And while it is true that absence of evidence is not necessarily evidence of absence, when you have looked hard enough for long enough for evidence that an idea is true and you have failed to find any, it becomes reasonable to take this failure as at least some evidence against the idea. So when I see clinical trials published concerning hypotheses that are implausible in themselves and that can only be true if mountains of evidence against them are all mistaken, I tend to give an exasperated sigh and set to reading the paper with some a priori bias against the hypothesis. Is this closed-minded? Only if expecting that an experiment designed to show the sun revolves around the earth will fail to do so is closed-minded. To be open-minded about ideas with a long history of failure to demonstrate their veracity and which require giving up much more solidly established ideas is not a virtue, it is wishful thinking or cognitive dissonance in action.

Homeopathy is an idea whose time has come and gone. It is theoretically implausible in the extreme, and decades of research have failed to support its theories or show any meaningful clinical effects. It is a flat-Earth hypothesis, and the expenditure of resources on further clinical trials to investigate it is the epitome of Tooth Fairy Science.  Trials such as these, however honest the intent behind them, merely muddy the waters by providing proponents of a failed idea with what would appear to be evidence to support their claims but what is in reality, if the balance of the voluminous research available is considered, not meaningful.

So whenever I see a study purporting to demonstrate a clinical effect of homeopathy, I look carefully at the designs, the statistics, and all the markers of quality for a scientific paper. I also look at the publication in which the study appears. There are some journals devoted exclusively to alternative medicine, and these exist only to publish CAM studies not judged to be of sufficient quality to be published in standard journals. These journals rarely publish negative findings (though to be fair neither do most mainstream journals), so a degree of skepticism about papers that appear in them is warranted.

I want to be fair to such studies, and to their authors who undoubtedly honestly believe that they are trying to use real, legitimate science to investigate a practice which their experience suggests has value. However, even if such studies are methodologically no more flawed than many which investigate truly legitimate ideas, they frustrate me. Especially in veterinary medicine, where resources for clinical research are so limited and where there are a multitude of serious problems and plausible potential solutions to investigate, it seems a shame to spend intellectual and material capital on an idea which a dispassionate analysis of the voluminous evidence would have long since caused us to abandon.

I recently came across a paper investigating the potential therapeutic use of homeopathy for mastitis in dairy cows, and I wanted to examine it closely both to see whether it met the standards for real evidence homeopathy might have clinical benefits as well as to provide an example of  how one approaches an evidence-based reading of a scientific publication. The first step in such a reading is to recognize the limitations of one’s own knowledge and expertise. As a small animal vet, I know very little about bovine mastitis, and I am certainly no statistician. So I sought help from colleagues more familiar with these subjects than I, and many people generously offered their perspective on this paper. I have incorporated these perspectives in my analysis, though any errors or misinterpretations arising from them are strictly my responsibility.

Werner, C. Sobiraj, A. Sundrum, A. Efficacy of homeopathic and antibiotic treatment strategies in cases of mild and moderate bovine clinical mastitis. Journal of Dairy Research 2010;77:460-467

The study design was a bit odd. Initially, 136 cows (147 affected udder quarters) were randomly allocated to treatment with antibiotics, homeopathy, or placebo, which is standard practice. The sickest cows, those with signs of systemic illness or a fever, were excluded. This introduces a possible bias as these are the cases most likely to need an effective therapy, whereas less ill animals are more likely to recover on their own regardless of the effectiveness of treatment. Most cases of mastitis are mild and may be self-limiting, depending on the organism involved, so it is appropriate to study interventions for these, but we must simply bear in mind that the effect of treatment may be harder to judge accurately when the diseases often resolves by itself.

The initial randomization was counteracted to some extent, however, by the fact that cases not responding to treatment in the first 5 days were shifted from whatever treatment group they were in to the other (antibiotic or homeopathic treatment), or from the placebo group to one of the two treatment groups. This decision was made at the discretion of one of the investigators, which introduces another potential bias.

Blinding of the farmers/owners to treatment group was incomplete as the antibiotic treatment approach differed significantly from the homeopathic and placebo treatments (which also differed somewhat from each other). After the first 5 days, the farmer took over treatment and was able to distinguish antibiotic treatment form the other two groups, which might have affected other aspects of their care and evaluation of the animals. So any assessments made after the first 5 days could be influenced by bias associated with the farmers knowing what treatment the cows were receiving and thus managing them differently.

The antibiotic treatment also involved local therapy applied directly to the teat, whereas the homeopathic and placebo treatment involved only oral medication administration. This, again could have influenced results if local treatment alone, regardless of agent or use of systemic treatment, had an impact on outcome.

The homeopathic treatments used were “low dilution” preparations, which unlike most common homeopathic remedies could actually contain some residual amount of the substance the remedies were prepared from. This raises the question of whether or not any effect seen would be due to homeopathic methods or to potential physiological effects of the original agents. This is significant since even is these agents have some effect, the majority of the homeopathic remedies in use no longer contain any of them, so most of these remedies would not be able to take advantage of any such effect.

The results mostly showed no difference between treatments, though cases of mastitis with positive bacterial cultures did seem to respond better to antibiotic treatment compared to homeopathic and placebo treatment. In fact, the authors themselves remarked, “in our opinion, contagious pathogens had to be excluded from mastitis studies dealing with alternative medicine because of their epidemiological background and the existence of well-proven conventional elimination strategies.” Essentially, they acknowledge that mastitis with infection already has an effective treatment and it would be unethical to deny this to patients in order to test alternative treatments.  Of course, this only leaves again the cases most likely to get better on their own to test and treat with alternative therapies.

The homeopathic treatment appeared to be statistically different from the placebo only at one of the 6 evaluation time points, Day 56 after the beginning of treatment, and only for the subgroup with positive bacterial cultures. The rate of total cure seen with antibiotic treatment was lower than reported elsewhere, which raises the possibility that the lack of a clear superiority of antibiotic treatment over homeopathy might be due to the failure of the antibiotic treatment applied in this trial rather than a true equivalence between antibiotic and homeopathic treatment.

Finally, from the point of view of statistical analysis, there were several issues that would decrease confidence in the conclusions. The sample size was relatively small, and the number of animals in the study may not have been enough to justify the statistical conclusions reached (not all the relevant information to judge this was provided in the methods section). The biggest problem with the statistical methods, however, and by far the most common statistical error made in papers reporting the results of clinical trials, is the use of multiple comparisons at multiple time points without correction for the probability of random positive results.

The threshold for statistical significance is usually set at 5%. This means that if you plan to compare two treatments in terms of a single measurement, say the percentage of animals cured in each group, then a statistically significant difference between the groups would only happen by chance 5% of the time, which is pretty unlikely. The difference could, of course,  be due to many other factors besides the original hypothesis of the investigators. Statistical significance does not mean the hypothesis is true, only that random chance by itself is unlikely to explain the difference seen.

However, the more comparisons you make, the more likely you are to get some that show a difference which isn’t real just by chance. There are statistical tools for correcting for this, but they do not appear to have been used in this study. Thus, comparing multiple measures (somatic cell counts, milk score, palpation score, etc) on multiple days is likely by random chance alone to lead to some difference that looks significant even though it isn’t. For such a difference to be accepted as real, it either needs to be evaluated by proper statistical methods or at least be seen repeatedly in multiple studies by different investigators.

If a large number of studies are done without appropriate correction for making multiple comparisons between groups, and if each one shows a couple of significant differences but these are not consistently the same measurement in every study, then it is likely that each study found a couple of false differences by chance. Yet in alternative medicine, such differences, even if only found in a couple of studies without appropriate statistical methods, is often cited as proof of a treatment effect. This is misleading. It allows one to cite many papers purporting to show an effect of a treatment, which conveys an impression of scientific legitimacy even if the difference shown by each paper is not real and there is no consistency among the papers as to what exactly the effect is.

Another methodological concern is the apparent use of unplanned subgroup analysis. This means that after the study data was collected, the authors divided the study groups into subsidiary groups (e.g. mastitis cases with positive bacterial cultures and with negative bacterial cultures) and then compared the responses of these subgroups to the different treatments. As with multiple outcome measures, subgroup comparisons can lead to false conclusions without appropriate statistical controls and careful interpretation of the results.

The study was published in the Journal of Dairy Science, which is a reputable scientific publication.

So overall, what can we conclude from this paper? Does it demonstrate “an effectiveness of the homeopathic treatment strategy as a ‘regulation therapy’ stimulating the activity of immune response and resulting in a long-time healing” as the authors conclude? Not at all. It is unclear exactly what this statement means in any case, but it is certain that the weaknesses in designs and execution of the study and data analysis do not allow a great deal of confidence in the hypothesis that homeopathy is as good as or better than antibiotic treatment, or even superior to no treatment, for mastitis in dairy cattle. In cases without bacterial infection and with only mild or moderate localized diseases, which are likely to get better without treatment anyway, homeopathy was not demonstrated to be any more or less effective than the antibiotic therapy used in this study, which was itself less effective than other studies have reported. By itself this would be pretty weak evidence for using homeopathy to treat mastitis.

Again, most scientific studies have such flaws or weaknesses, and this one is not exceptionally inferior in design or executions. However, when the specific flaws of the study are considered in conjunction with the weaknesses of the theory underlying the homeopathic approach and the overall failure of decades of scientific research to show any benefit to homeopathic treatment, the results are essentially meaningless. To overcome the theoretical issues and the failure of any evidence of effectiveness to accumulate despite the amount of research so far done on homeopathic remedies, a quite dramatic and unequivocal result would be necessary to raise any reasonable question of whether homeopathic treatment might be beneficial. This study provides no such results.

Could studies such as this be done better, with fewer methodological flaws? Sure? Should they be? Do we really need still more negative or inconclusive studies of homeopathy before we are allowed to judge it a useless therapy without being accused of unscientific closed-mindedness? Or must we continue to test every possible hypothesis that has its advocates indefinitely? If we are never allowed to declare an idea dead, thenwhat purpose does science serve?

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