Todo exceso produce insomnio – ABC Color

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Todo exceso produce insomnio
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“La invasión de los dispositivos electrónicos en las camas puede contribuir al alto número de personas que afirma dormir habitualmente menos de lo que necesita”, explicó el doctor Charles Czeisler, del Harvard Medical School. ...
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Triskaidekaphobia times two.

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There is germaphobia, the fear of germs. Or Germans.  One of the two. Oddly, I do not fear most germs, despite my daily reminders as to how destructive these wee beasties can be.   I recognize their limits and my immunologic strengths and know I have more to fear from cars or unsaturated fats than E. coli or influenza.

There is also a fear of vaccines, the too many too soon that is said to be at the heart, or maybe the left atrial appendage, of one of the imaginary problems with vaccines.  There are, by my counting, 5 live attenuated viruses and 21 different antigens in the vaccine schedule by age 6, for a total of 26 or twice thirteen.  Some fear those antigens and viruses, making it a  triskaidekaphobia times two (1).

From my perspective the paltry quantity of antigens children receive with the vaccine schedule are, when compared to the enormity of antigens in the environment, a rounding error.  We are awash in bacteria, fungi, viruses and an enormous number of environmental organisms.  I think of each of us like Pig-Pen, but instead of dirt, we are in a cloud of micro-organisms.

Our immune systems, contrary to the opinions of the unimaginative who direct scorn and derision at Dr. Offit, can cope.  As discussed, we have a ability to stave off the phenomenal number of organisms that would just as soon use us as the ultimate supersized meal.  Of course, it is not all the immune system that keeps the wee beasties away.  Being warmer than ambient temperature helps.  Understanding disease epidemiology, hygiene and the prn malum q 24 h also keeps the doctor away.Hygiene is an interesting two edged sword, and the rule in medicine is that no good deed goes unpunished. We are cleaner, at least in the urban industrialized wWest, than  most people through most of history.  Exposure to a large assortment of environmental filth and germs, with the exception of my 13 year old’s bedroom, is rare.  Cleanliness has helped to decrease the spread of contagion both in the community and in the hospital, at least for those who believe in good hand hygiene (2) and sterile technique.

However, lack of exposure to the background microbiology has had a potentially interesting downside.  Several epidemiologic studies have demonstrated an association between, to put it crudely, increased cleanliness and an increase in asthma and atopy (3).   The NEJM had a recent article with a similar result,  Exposure to Environmental Microorganisms and Childhood Asthma. From my perspective, this link between cleanliness and allergic disease  is interesting, but not what I want to focus on.  An interesting suggestion of this study is that, while you cannot boost the immune system, evidently the immune system needs a good microbial work out as it develops to ensure proper functioning as an adult.  Not only is the infants immune system able to process and react to a mind boggling number of antigens, apparently it needs to be exposed to these antigens in childhood for optimal function.  The motto ‘Use it or lose it’ applies to B cells as well as biceps.

In the NEJM study they surveyed the bedding and dust for microorganisms in the environment of children who live on farms and those that live in an urban environment.  They did both microbiology counts and molecular methods to evaluate the number of organisms in the environment.

Kids on farms live in a haze of bacteria and fungi at levels far higher than their urban counterparts and to their benefit. Organisms isolated included

“Listeria monocytogenes, Bacillus licheniformis and other bacillus species, corynebacterium species, methylobacterium species, xanthomonas species, enterobacter species, pantoea species, and others. …Staphylococcus sciuri and other staphylococcus species, salinicoccus species, macrococcus species, bacillus species, jeotgalicocus species, and others. …eurotium and penicillium species”

I no longer feel  as bad about the time my son was playing in the dirt, flipped a rock over and, before I could react, ate the slug he found underneath.  He was just exercising his young immune system. The NEJM study only evaluated the microbiology of the inside environment; there was no measurement of the larger outside environmental community.  I would imagine the number of organisms outside the home dwarfed what they could find inside.

As the accompanying editorial notes

“… that newborns begin to be colonized by microbes at birth, coincident with a period of rapid development of the immune system and lungs. These symbiotic organisms can be beneficial (e.g., gut bacteria that synthesize vitamin K) or pathogenic, or they may have no effect on the host (commensals). The authors propose that microbes found on farms adeptly stimulate innate immune receptors in early life and thereby favor the generation of regulatory T cells that promote immunologic tolerance.”

and the results are limited by

” microbial diagnostics provid(ing) only a low-resolution picture of microbial identity and diversity.”

There are far more wee beasties in and on us that we can currently identify. Farms, I would wager, are filled with far fewer bacteria than the environment in which pre-industrialized humans evolved.  Too many too soon runs counter, as does much of what is understood by antivaxers, to reality. When you are young, you can’t get enough.  The early immune system is the Johnny Rocco of the body (4).

The world is a crowded place at the level of the microorganism and we have evolved to respond to that crowding from birth.  Not just respond, but we need to be exposed to these antigens.

“Nothing is unnatural – just untried.” ~Rita Mae Brown

It may be argued that vaccines are not natural, whatever natural is.  I am the result of natural selection, so is not everything I do natural?  Infection with a needle is not how bacteria, fungi and virus get into the body.  I suppose this is a group of people who never had a percutaneous injury with a splinter or a cut from a thorn or a child who did not skin their knee on the dirt.  Percutaneous inoculation is a common way to be exposed to environmental antigens, just not as safe a way when sterile technique is avoided.

One would wonder if vaccines, in our ever so clean modern environment, could not only protect against the plagues of the past, but be a surrogate for our former environmental exposure to microbial squalor?

“adolescents having been vaccinated (n = 694) had a significant lower risk to suffer from asthma or atopic diseases than non-vaccinated adolescents did (n = 24) [odds ratio (OR) = 0.30; 95% CI: 0.10, 0.92]. The relationship did not depend on the disease against which the vaccine was used as prophylaxis, the observance of the vaccination schedule or the number of inoculations. A higher protection was observed in the case of live attenuated vaccines (oral poliomyelitis and bacilli Camille-Guerin; OR = 0.26; 95% CI: 0.08, 0.83). These results, in agreement with previous ecological data, support the hypothesis that early vaccines could promote Th1 proliferation in response to the infectious agent contained in it, which inhibits the enhancement of atopic manifestations. Further studies are needed to confirm the phenomenon.”

None of the above is  rock solid information when applied to vaccines, but an intriguing curiosity and, perhaps, hints about into disease etiology, but interesting when considering the potential responses of children to vaccines.  Too many too soon?  Doubt it.  Just enough, just in time?  Maybe.  Consider that receipt of MMR on schedule has been associated with decrease in autism.  I, of course, do not know what causes autism.  I had thought that the MMR results could be explained by lack of protection to neurotropic virus in the unvaccinated, but now I wonder.  There are articles on autoimmunty as a factor in autism, way beyond my current knowledge base . I will defer to others on the validity of these studies, I note them with interest but no deep understanding.

I think all human disease has, at its core, an association with infections. Most of the microbial studies on autism have concerned the use of antibiotics to treat the disease.  Autism rates have increased along with the expanded vaccine schedule, increasing cleanliness, global warming and the decline in pirates. The Amish do not get autism and they don’t live in a (relatively) sterile urban environments, and use a horse and buggy for transportation.    There must be a association in there somewhere that is actually causal. I know, probably not, but play along at home.

Let us  speculate: It would be ironic if  someday it was determined that part of the etiology of autism is, like asthma,  partly due to our microbial free environment and subsequent immune dysregulation and that vaccines, by supplying a surrogate immune stimulation, are protective.  Those who fought vaccines as a cause of autism turn out to be partly responsible for autism’s spread.  Truly worthy of  Medical Hypothesis, I admit, but it is amusing to speculate.  Someday science will sort it out.

It is fun to think about possible ramifications of the current literature.  I would certainly not use the speculation as a basis for my practice or to develop a therapeutic or preventative intervention with an exclamation mark. Hmm.  Or should I? I need to patent  a neonatal and infant probiotic  autism prevention supplement (NIPAPS!) containing the correct proportion of live and killed naturally occurring environmental bacteria and fungi.   There is a fortune to be made if I can just get rid of my ethics and morals.

Rationalization.

(1)  Not certain what ancient Greek for ’26′ would be.

(2)  Stay away from the Atlanta VA ICU. http://www.medscape.com/viewarticle/737884

(3)  Sorry.  Just epidemiology.  No gold standard, randomized, placebo controlled, blind trials utilizing the hypothetical/deductive technique, so ignore everything that follows. I am a snot.

(4) Johnny Rocco: Well, I want uh …
Frank McCloud: He wants more antigens, don’t you, Rocco?
Johnny Rocco: Yeah. That’s it. More. That’s right! I want more antigens!
James Temple: Will you ever get enough?
Frank McCloud: Will you, Rocco?
Johnny Rocco: Well, I never have. No, I guess I won’t.
~ Key Largo

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Is “CAM” Fraud?

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During my continuing education about so-called “complementary and alternative” medicine one question presents itself in my mind over and over: Isn’t that fraud?   Well, is it?

And by “CAM,” I mean …

The book Snake Oil Science, by R. Barker Bausell, defines “Complementary and Alternative” therapies as “physical, mental, chemical, or psychic interventions … practiced in the absence of both 

  • scientific evidence proving their effectiveness and 
  • a plausible biological explanation for why they should be effective, 

and their practice continues unabated even after 

  • …there is scientific evidence that they are ineffective and 
  • …their biological basis is discredited.”  

(Emphasis added.)

Science Based Medicine has given us an abundance of examples supporting Dr. Bausell’s definition: homeopathy, subluxation-based chiropractic , energy healing , acupuncture , and so on. 

Fraudulent Misrepresentation

Unfortunately for ‘CAM” products and practitioners, there is no equivalent of “alternative medicine” in the law.   “Conventional law” will have to do for our analysis.  In “conventional law,” fraud can be a crime, a breach of contract or a tort.  Here we will confine our analysis to fraud as a tort, that is, a private or civil wrong, independent of contract, and more particularly the tort of fraudulent misrepresentation.

Tort law varies from state to state, and a discussion of the law of fraudulent misrepresentation in all 50 states (plus assorted other U.S. jurisdictions) is beyond the scope of this post.  However, the Restatement of Law 2d, Torts,1 [hereinafter, the Restatement] is widely regarded as the best compilation of current law on the subject.   “The Restatements … are famous as an effort to bring analytical coherence into nonstatutory fields of law otherwise marked by a flood of discrete instances and judicial rationalizations of divergent results.”2  Where the law is in flux, they offer recommendations based on policy grounds. The Restatements of various areas of the law (Torts, Contracts, Agency, and so on) are highly respected and often cited in court opinions.    

According to the Restatement, Sec.  525, if A 

  1. fraudulently makes a misrepresentation of fact, opinion, intention or law to B 
  2. for the purpose of inducing B to act (or refrain from acting), 
  3. A is liable to B for  B’s monetary loss 
  4. caused by B’s justifiable reliance on the misrepresentation.  

“Monetary loss” includes loss caused by physical harm in cases where there is a duty to disclose a fact.  Restatement, Sec. 557A.  “Misrepresentation,” as you might guess, means that the representation is “untrue,” “not in accordance with the facts.”3 Actions for fraudulent misrepresentation (as distinct from malpractice) have been successfully maintained against health care providers, including M.D.s, dentists and chiropractors.4

Let’s consider more closely that first element: under what conditions is a misrepresentation considered fraudulent?  That is largely a question of intent (or “scienter”). But, contrary to what some may think, actual lying is not required to hold one accountable.  According to the Restatement, Sec. 526, 

A misrepresentation is fraudulent if the maker

  1. knows or believes that the matter is not as he represents it to be,
  2. does not have the confidence in the accuracy of his representation that he states or implies, or
  3. knows that he does not have the basis for his representation that he states or implies.

Subsection (a.) describes what we colloquially call “lying.”  But subsection (b.) and (c.) do not require actual knowledge that one’s statement is false to impose liability. According to the Restatement’s comments to Sec. 526, which further explain its meaning, A cannot state to B that X is a fact when A merely believes it is a fact but recognizes there is a good chance it is not true.  This is sometimes referred to as making a statement “recklessly,” careless as to whether it is true or false.   Nor can A tell B that he knows X to be a fact based on his personal knowledge or investigation, or imply that this is the case, when A actually has no personal knowledge or has not made an investigation, even where A is honestly convinced of the truth of his representation.  

Misrepresenting Science

Lack of scientific evidence as misrepresentation

To understand “CAM” in the context of fraudulent misrepresentation, let us first consider the sale of goods and services outside the “CAM” area.  Will the lack of scientific evidence for a product’s or service’s claims support a cause of action for fraud? 

The tobacco cases provide an excellent example of how one industry misrepresented the scientific evidence and got burned for its efforts.    Here, we’ll look at just one of the many cases brought against a tobacco company for, among other things, fraudulent misrepresentation.

In Henley v. Philip Morris,5 the defendant tobacco company claimed on appeal that there was insufficient evidence to support the jury’s finding of liability on plaintiff’s claim of fraudulent misrepresentation.  The court thoroughly rejected that argument:

Our review of the record satisfies us that there was substantial evidence that [defendant] engaged in a conscious, deliberate scheme to deceive the public,  … about the health hazards and addictive effects of cigarette smoking. The jury could properly find that … defendant and other cigarette manufacturers acted both in concert and individually to issue innumerable false denials and assurances concerning the dangers of smoking, deliberately fostering a false impression by the public … that assertions of health risk were overblown … , that any real hazards had yet to be shown, and that the industry itself was acting and would act diligently to discover the scientific truth of the matter and promptly disclose its findings, good or bad. The jury could also find that plaintiff   … was falsely led to believe, as defendant intended, that there was a legitimate ‘controversy’ about whether cigarettes actually caused cancer or carried any other serious health risks.

Does this remind anyone of another fairly recent controversy regarding the safety of a certain “CAM” procedure, discussed here, here
and here?

In addition, defendant argued that its statements were “opinions,” not statements of fact, and were therefore not actionable.  That argument was equally unpersuasive to the court:

This argument relies on the general rule that statements of opinion will not support an action for fraud, while ignoring the exception … applicable to any statements of opinion: ‘[W]hen one of the parties possesses, or assumes to possess, superior knowledge or special information regarding the subject matter of the representation, and the other party is so situated that he may reasonably rely upon such supposed superior knowledge or special information, a representation … though it might be regarded as but the expression of an opinion if made by any other person, is not excused if it be false.  … Further, if a statement of opinion ‘misrepresents the facts upon which it is based or implies the existence of facts which are nonexistent, it constitutes an actionable misrepresentation.’ … The jury here was entitled to find that insofar as any of defendant’s statements constituted opinions, they implied the existence of superior knowledge as well as a state of facts that did not exist.

  In another example, a number of claims for fraud were brought against Amoco for false advertising arising out of Amoco’s assertions regarding its gasoline’s benefits.6  In one of these cases, plaintiff claimed that the following representations were “made without any competent and/or scientific substantiation”:

‘The clear color of Amoco Ultimate gasoline demonstrates the superior 
engine performance and environmental benefits Amoco Ultimate provides compared to other premium brands of gasolines that are not clear in color;

A single tankful of Amoco Silver or Ultimate gasoline will make dirty or clogged fuel injectors clean … ’

Do you notice a certain similarity between Amoco’s second claim and those made for colonic irrigation?

Thus, the answer is yes, as common sense would indicate, lack of scientific evidence, or distortion of the actual evidence, for a product or service will support a cause of action for fraudulent misrepresentation.  Even if the misstatement would otherwise qualify as an opinion, it is actionable fraud if the statements imply superior knowledge and are based on non-existent “facts.”

Implausibility as misrepresentation

It is difficult to find cases discussing the other element of Dr. Bausell’s “CAM” definition—lack of a plausible basis in science (as opposed to lack of scientific evidence for claims about the product or service).  Of course, outside of ‘CAM,” what sort of product or service would fit that description?    Levitation  lessons?  A perpetual motion machine?  Man-capturing  perfumes? In fact, yes, all of these have elicited the judicial equivalent of “you gotta be kidding!” 

In Hendel v. World Plan Executive Council and Maharishi International University,7 plaintiff sued for fraud arising out of defendants’ claims that, according to her complaint, courses in Transcendental Meditation would allow her to “attain certain extraordinary powers, such as clairvoyance, ability to levitate, ability to fly, invisibility, and superhuman strength.” In addition, she “would ultimately become a ‘Master of Creation’ with the ability to manipulate the physical world and the laws of nature.”  

The court did not reach the merits of her fraud claim, finding instead that her suit was barred by the statute of limitations.   However, in reaching that conclusion, the court did remark that defendants’ representations were such that “any reasonable person would recognize as being contrary to common human experience and, indeed, to the laws of physics.” This meant plaintiff should have been on notice earlier that she was being defrauded.  

Similarly, in Waterman v. Haumaier,8  the laws of physics prevented one party from claiming he could justifiably rely on representations in an agreement which “closely approach the concept of the perpetual motion machine … [S]uch machines  … are impossible in light of the First Law of Thermodynamics,” citing Handbook of Chemistry and Physics  (64th ed. Weast 1983).   

Less specifically, but equally based on scientific implausibility,  in Gottlieb v. Schaffer,9  the court found that various perfumes the seller claimed would allow the wearer to “control men” (“Desire” perfume), to make a man “stay close to you” (“Nirvana”), “make men obey you” (“Command”), and so on, were so “patently absurd” that no proof of their falsity or intent to deceive was necessary due to “the universality of scientific belief that [such] advertising representations are wholly unsupportable.”   The Gottlieb case was decided in 1956, which makes me think the perfume seller was simply ahead of his time and could have marketed his product as a combination of aromatherapy and energy medicine in today’s market.
 
Thus, both the lack of a plausible basis in science and the lack of scientific evidence for claims made for products or services are well-recognized as “misrepresentations” which will  support a cause of action for fraud.   Now let’s apply the law of fraudulent misrepresentation to a few hypotheticals involving “CAM.”

B, the poor devil10

Acupuncture

Imagine that A is an M.D. practicing family medicine.  His patient, B, has long complained of back pain, but has not found relief in any of the remedies A has prescribed.  The doctor, being an “integrative” practitioner, suggests acupuncture, which he has learned to perform, might help B’s pain, adding that he has “seen it work” in other patients.  B justifiably takes all of this to mean that acupuncture is an effective treatment for back pain, and relies on that representation.  B undergoes a series of 12 treatments, which costs about $1,200. In fact, A is aware, from his undergraduate education in the sciences and his medical education and training, that the basic principles of acupuncture are highly implausible and, having reviewed the literature, knows there is no good evidence that it is effective. Thus, A knows that his express and implied representations of the effectiveness of acupuncture for back pain are “not as he represents [them] to be” within the meaning of Sec. 526(a). Therefore, all the elements of a cause of action for fraudulent misrepresentation under Sec. 525, are present.  

Naturopathy/Homeopathy

Next, let’s suppose that A is an N.D. licensed to practice naturopathy in her state.  B, her patient, has the flu, so A prescribes oscillococcinum, which she describes to B as a homeopathic flu remedy.  A, having taken classes in chemistry and physics, has her doubts about homeopathy, but she does not express them to B. B justifiably relies on A’s advice because A is a licensed health care provider.  B takes the homeopathic remedy, but continues to suffer because, as we know, homeopathic remedies cannot be, and have proven not to be, effective.  As a result, B is out the cost of the remedy plus additional monetary losses due to the physical harm caused by ineffective treatment, which delays her seeking medical care for the flu, which progresses into pneumonia.   A’s conduct has thus satisfied the definition of fraudulent misrepresentation under Sec. 526, subsection (b), as she knew when she prescribed  oscillococcinum that homeopathy is inconsistent with the laws of chemistry and physics and therefore could not be confident that it was, in fact, an effective remedy.  In other words, she did “not have the confidence in the accuracy of [her] representation that [she] states or implies.”  All the elements of a cause of action under Sec. 525 are present.  

Chiropractic
 
Assume A is a D.C.  B visits his office for the first time, complaining of headaches.  A explains to B that he is suffering from subluxation of a cervical vertebrae, the cause of his “cerviocogenic headache,” and that cervical manipulation will reduce the subluxation, thereby allowing the body’s self-healing ability to function properly.  B asks A about the safety and effectiveness of this treatment.  A responds that “the scientific evidence for the safety and effectiveness of chiropractic care is overwhelming.”  He adds that “over the past twenty years, many controlled clinical research studies have shown that chiropractic care is safe and effective for back pain, neck pain and headaches.”11   B justifiably relies on these statements due to the chiropractor’s presumed superior knowledge on these subjects.   

In fact, A has not reviewed the recent literature on the scientific validity of the chiropractic subluxation, which does not support its existence. Nor has he reviewed the recent literature on the safety and effectiveness of cervical manipulation for headaches, which does not support his unequivocal statement.   He is simply repeating statements in a patient brochure he purchased in bulk for his office. Unfortunately, the cervical manipulation causes B to suffer a vertebral artery dissection and subsequent stroke, resulting in lifelong disability.  A’s conduct satisfies the definition of fraudulent misrepresentation as he did not actually investigate the literature and therefore “knows that he does not have the basis for his representation that he states or implies.”  This is so even though he “is honestly convinced of its truth from hearsay or other sources that he believes to be reliable.”  Restatement, Sec. 526(c), and comment (f).  All the elements of a cause of action for fraudulent misrepresentation under Sec. 525 of the Restatement are present.

Reiki

Finally, assume A, a licensed massage therapist in her state and a reiki practitioner, places an ad for her services in the newspaper, and is contacted by B, who asks for more information.   A tells B that reiki is based on the idea that there is a universal, or source, energy that supports the body’s innate healing abilities. Practitioners seek to access this energy, allowing it to flow to the body and facilitate healing.  A adds that people use reiki for relaxation, stress reduction, and symptom relief, in efforts to improve overall health and well-being and that reiki has been used by people with anxiety, chronic pain, HIV/AIDS, and other health conditions, as well as by people recovering from surgery or experiencing side effects from cancer treatments. A tells B that if it is inconvenient for her to come in, A can practice reiki from a distance, that is, when B is not physically present in the office. B tells A she suffers from chronic anxiety and pain and schedules an appointment.  A tells B after her first session that the standard for treatment is at least four sessions of 30 to 90 minutes each.12  B ultimately ends up attending 10 sessions, and having reiki performed without her presence twice, which costs her $1,000 total.

In a departure from the previous hypotheticals, it is not certain that B can satisfy all the elements of proof to succeed on a claim of fraudulent misrepresentation against A.  A’s description of reiki’s purported mechanism of action is clearly contrary to the laws of physics, so much so that one can argue the average person should be aware of its implausibility.  Even if B can prove that A knew, or should have known this, reiki’s very implausibility might keep B from being able to prove she justifiably relied on A’s statements, as was the case in Waterman.  Hendel, although decided on a different issue, points to the same result.  However, for the purposes of our discussion below, let’s assume the facts in this hypothetical satisfy all the elements of a cause of action for fraudulent misrepresentation under Sec. 525.

A license to defraud?

I’ve concluded that all the elements of a cause of action for fraudulent misrepresentation are present in each hypothetical.    However, that is not the same as concluding the plaintiff will succeed (assuming he or she can prove the allegations of the complaint) because in any suit the defendant can plead and prove an “affirmative defense” which defeats the plaintiff’s claim.  By way of example, one common affirmative defense is failure to bring an action within the time provided by the statute of limitations, as was the case in Hendel, above.   Ms. Hendel may have had a textbook claim of fraudulent misrepresentation against the defendants,   but because she waited too long to bring her suit, the defendants won on their affirmative defense that her claim was barred by the statute of limitations.  

So what affirmative defense might be raised to defeat claims of fraudulent misrepresentation brought by B against A?  

Again we turn to the …

Restatement:

“Sec. 890 Privileges

“One who otherwise would be liable for a tort is not liable if he acts in pursuance of and within the limits of a privilege …” 

Sec. 10 of the Restatement further describes the types of consent and how they are created.  Some privileges are based on the consent of another.  The most familiar of these to readers of SBM is likely consent to medical treatment, so that the person who cuts one open with a sharp object will not be liable for battery if that person is a surgeon and one has consented to the surgery.  We are not talking about that kind of privilege here even if consents to treatment were obtained as consent induced by fraud is invalid.  

Other privileges are nonconsensual, and they can be either conditional or absolute.  These privileges allow the A’s of the world to adversely affect the legally protected interests of the B’s of the world without their consent and to avoid liability for doing so.  Absolute privilege is not applicable here.  It is the conditional privilege which may form the basis of an affirmative defense in our hypotheticals. 

“A person ‘who otherwise would be liable for a tort is not liable if he acts in pursuance of and within the limits of a privilege.’ … The term ‘privilege’ denotes the existence of circumstances that justify, or excuse, conduct that would ordinarily subject the actor to liability… . Conduct that would otherwise be actionable is held to be privileged as a matter of law where, under the circumstances, it furthers an interest of social importance.”  Schultz v. Elm Beverage Shoppe,13  quoting, Restatment, Sec. 890.

However, a person is liable for any acts that are in excess of those permitted by the privilege.  Thus, if A acts in self-defense during an attack by B, the privilege of self-defense against attack by another would protect him from liability for injury to B.  But if A uses excessive force he has exceeded the scope of his privilege and the privilege will not protect him from liability for injuries caused by his use of unnecessary force.  Restatement, Sec. 890, comment e.

Privileges can be based on a constitutional or statutory provision protecting the alleged wrongdoer’s interests even where the creation of the privilege is not specifically mentioned.14  A familiar example is the privilege protecting the media from a claim of defamation where the defamatory statement was published without malice or reckless disregard of the truth (and a few other requirements).  This privilege is recognized by the courts to protect First Amendment freedoms, although obviously you don’t find actual language to that effect in the First Amendment.   
 
The defendants in our hypotheticals can raise the affirmative defense of conditional privilege. The M.D., N.D., D.C. and L.M.T. would all argue that because their practice acts incorporate a right to perform the procedures which the patients claim are fraudulent, the practice acts create a privilege.   In other words, the state legislatures, by incorporating implausible and evidence-free practices into the law, are protecting these practitioners from liability even if their patients can prove their representations are untrue and were made with the requisite intent to deceive.  

The D.C. and the N.D. appear to have the best case for defeating the patient’s claim of fraudulent misrepresentation, as their practice acts incorporate their science-and-evidence-free procedures. All state chiropractic acts either explicitly or implicitly allow chiropractors to detect and correct “subluxations.”15  However, any privilege afforded by the practice act obviously would not extend to statements regarding the safety of cervical manipulation as that subject is not specifically addressed in the act.  Likewise, because the naturopathy practice acts allow the use of homeopathy, the N.D. can plead privilege as an affirmative defense, although it could be argued that she exceeded the scope of her privilege by not disclosing her doubts about homeopathy.

The L.M.T’s claim of privilege would depend on whether her state included reiki in the definition of massage practice.  If it does, the court could find that the statute creates a privilege.  If not, there would no statutory basis for it, although she might argue that by virtue of the state’s allowing practices “taught in massage schools” (as some do) the practice act implicitly affords a privilege if her massage school training included reiki.

The M.D. is on shakier ground.   While some states have enacted statutes protecting physicians to a certain extent in using “CAM”16 it is unlikely those would protect an M.D. who believed in neither the plausibility nor effectiveness of the treatment but, at least impliedly, represented otherwise to the patient.   In addition, some of these statutes protect a physician solely from disciplinary action for using CAM and arguably create no privilege in a civil action. Thus, even though the M.D.’s scope of practice is broad, it does not insulate physicians from knowingly making false claims about a therapy. 

In response to claims of privilege, plaintiffs could argue that a nonconsensual privilege which defeats their right to recover damages for fraudulent misrepresentation should not be recognized unless it protects some important public interest. Restatement, Sec. 10, comment (d.); Sec. 890, comment (a.).  Certainly there is no important public interest served by allowing health care practitioners to make demonstrably false representations to patients.   
 

Conclusion

So, is ‘CAM’ fraud? According to the Snake Oil Science definition, it most certainly is misrepresentation.  Whether it is fraudulent misrepresentation depends on whether one of the three elements required for establishing fraudulent intent can be proved: knowing misrepresentation, reckless misrepresentation, or stating (or implying) a basis for the misrepresentation that one does not actually have.   As criticism of CAM for scientific implausibility grows and study after study fails to support claims of effectiveness, we may reach a point where it becomes impossible for the CAM practitioner to avoid knowing that CAM is based on misrepresentations, making it much harder to defeat claims of fraudulent misrepresentation.  Key to this will be the courts’ refusal to interpret the state practice acts as creating a privilege which allows CAM practitioners to avoid liability for defrauding their patients.

References

  1. Restatement of the Law 2d, Torts, American Law Institute (1979) Return to text
  2. U.S. Nat. Bank of Oregon v. Fought, 630 P.2d 337, 352 (Or. 1982) (Linde, J., concurring). Return to text
  3. Black’s Law Dictionary (4th Ed. 1968) Return to text
  4. Ohlsson GL, Malpractice Considerations in Complementary Medicine, in Louisell & Williams, Medical Malpractice, Sec. 17D.04 (Matthew Bender 2010) Return to text
  5. 114 Cal. App. 4th 1429, 1465-66, 9 Cal. Rptr. 3d 29, 62 (Cal. App. 1st Dist. 2004), cert. den., 544 U.S. 92, 125 S. Ct. 1640 (2005) Return to text
  6. Oliveira v. Amoco Oil Co., 776 N.E.2d 151, 156, n. 2 (Ill. 2002) Return to text
  7. 705 A.2d 656 (D.C. App. 1997) Return to text
  8. 222 B.R. 40, 1998 U.S. Dist. LEXIS 10124 (S.D.N.Y. 1998)141 F.Supp. 7 (S.D. N.Y. 1956) Return to text
  9. Because B, through no fault of his own, is the second letter in the alphabet, he is constantly subjected to A’s actions, both devious and innocent, in the legal literature: A sells B real property A doesn’t own, rear ends B in traffic, shoots B in self-defense, fails to deliver goods B has purchased, and so on. Return to text
  10. This is actually a direct quote taken from a video about the safety and effectiveness of chiropractic featuring Rick McMichael, D.C., described as the president of the American Chiropractic Association. The video appears on the Sharecare website. http://www.sharecare.com/question/chiropracticcareeffective According a Sharecare press release, the site was created by Dr. Mehmet Oz and Jeff Arnold. Return to text
  11. http://static.sharecare.com/docs/SharecareLaunchRelease100710.pdf?v=47 Return to text
  12. This description is taken almost verbatim from the NCCAM website. “Reiki: An Introduction,” http://nccam.nih.gov/health/reiki/introduction.htm. Return to text
  13. 40 Ohio St. 3d 326; 533 N.E.2d 349, 351 (1988) Return to text
  14. See, e.g., New York Times v. Sullivan, 376 U.S. 254, 84 S.Ct. 710 (1964) Return to text
  15. Bellamy JJ, Legislative Alchemy: the state chiropractic practice acts, Focus Alt & Comp Ther; 15: 214-222 Return to text
  16. Cal Bus & Prof Code Sec. 2234.1 (2010); Fla.Stat. Sec. 456.41 (2010) Return to text

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The Dark Side of Medical Globalization

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“You are not going to change what we do, you’re not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I’ve looked after them for years. I’ve seen them after the procedure, the vast majority are improved.”

The above quote could be a reference to just about any fringe medical treatment. It is partly an expression of faith in anecdotal experience over scientific evidence. It is partly the fallacy of justifying a treatment because it is needed – whereas the real question is whether or not the treatment works. It is an attempt to justify specific claims with compassion, as if the person quoted cares more for the health of their patients than those who might be skeptical of their claims. And it is an expression of stubbornness – I know the truth, so don’t confuse me with evidence and logic.

Is this person talking about acupuncture? Perhaps they run a stem cell clinic in China, India or somewhere outside the reach of regulation. Or maybe they are defending hyperbaric oxygen therapy for unproven indications, like autism. It could be anything, because this sentiment is the standard mantra of the dubious practitioner, practicing outside the bounds of science-based medicine.

The quote is from Dr. Tom Gilhooly, a GP who runs Essential Health, a clinic in the UK that offers the liberation procedure for presumed CCSVI (chronic cerebrospinal venous insufficiency). Gilhooly is defending his practice to the BBC, after a healthy investigator, Sam Smith, presented to his clinic and paid to have a screening procedure performed – which diagnosed her with CCSVI.

I wrote about CCSVI last year – this is a controversial claim by vascular surgeon Dr. Paolo Zamboni, who believes that multiple sclerosis (MS) is caused by venous insufficiency in the brain. The liberation procedure uses balloons to open up the allegedly blocked veins, and in some cases stents are place to keep the veins open. Since my last reporting there have been several more attempts to replicate Zamboni’s research – all negative. This study compares MS patients to patients with other neurological disease and healthy controls, and found no significant difference in the prevalence of signs of venous insufficiency. Another study found that venous pressure is not different in MS patients vs normal controls Yet another study found a lack of association between CCSVI and HLA DRB1*1501 in MS patients, which is a genetic variant that carries an increased risk of developing MS.

The bottom line is that, so far, it is not looking good for CCSVI being a real disorder that is associated with, let alone a major cause of, MS.

Further – there is no clinical data (other than anecdotes) to demonstrate that the liberation procedure is a safe and effective treatment for any subtype of MS. But the claims for the treatment are dramatic, there is impressive-sounding anecdotal evidence of benefit (because there always is – no matter what the alleged treatment), and in many patients MS is a debilitating and progressive disease that does not always respond to treatment. In other words, there are desperate patients out there, and the combination of desperation and dramatic claims leads to people seeking treatment, despite the lack of scientific evidence.

These situations require thoughtful regulation in order to ensure that patients are not exploited (even by well-meaning practitioners, and we certainly cannot assume that everyone offering an expensive treatment is going to be well-meaning). The system needs to allow for some flexibility within the standard of care, and certainly for experimentation to advance the science of medicine. But this has to be balanced with the needs of informed consent and ethical practice and research.

This can be a difficult balance to strike. But as some countries are struggling to achieve the optimal balance of freedom and protection at the edge of scientific knowledge, medical tourism is undercutting such efforts.

The BBC reports, for example, that while the NHS does not cover the liberation procedure, thousands of patients have already gone overseas to have the procedure. There are reports of at least two deaths from the procedure, so it is not without its risks.

Clearly, use and demand for the liberation procedure has raced ahead of the evidence, which is mostly negative. More research is needed to put this claim to bed, or perhaps discover a more limited role for this syndrome and its treatments. But there is certainly an insufficient basis to offer the procedure outside of an ethically designed and executed clinical trial.

This is not an isolated example, nor is it even the worst example. Stem cell tourism appears to be a much greater problem, with patients (victims) spending tens or hundreds of thousands of dollars to fly around the world to get unknown cocktails (claimed stem cells) injected into them without any reasonable expectation of benefit, but with clear risks.

We are seeing the globalization of high-tech quackery. Current regulatory systems are not designed to address this problem All we can do is ask countries in which these clinics thrive to crack down, but there is a reason why such clinics are set up in these countries to begin with.

Meanwhile we can educate the public, and potential victims, about the evidence and the dangers. But information is often impotent against the power of desperation.

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Eating Placentas: Cannibalism, Recycling, or Health Food?

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After giving birth, most mammals eat the afterbirth, the placenta. Most humans don’t. Several hypotheses have been suggested as to why placentophagy might have had evolutionary survival value, but are there any actual benefits for modern women? Placentophagy has been recommended for various reasons, from nutritional benefit to preventing postpartum depression to “honoring the placenta.” In other cultures, various rituals surround the placenta including burial and treating it as sacred or as another child with its own spirit. Eating the placenta is promoted by some modern New Age, holistic, and “natural-is-good” cultural beliefs.

Some women eat it raw, but many women have a yuck-factor objection to eating raw bloody tissue. It can be cooked: recipes are available for preparing it in various ways. For those who don’t like the idea of eating the tissue, placenta encapsulation services are available, putting placenta into a capsule that is more esthetically acceptable and that can even be frozen and saved for later use in menopause.

Does placentophagia benefit health? Does it constitute cannibalism? It it just a way to recycle nutrients? How can science inform our thinking about this practice?

Is It Cannibalism?

As I researched this, I found the assertion that the placenta is part of the woman’s body. Actually, this is inaccurate. While there is a maternal component, placental tissue is mainly derived from the fertilized egg and carries the fetus’s genome. So technically, wouldn’t eating the placenta fit the definition of cannibalism: eating the flesh of another individual of your own species? Some people have categorical philosophical or ethical objections to cannibalism, but there is no evidence (and no reason to think) that eating “long pig” would be harmful to health as long as the tissue is healthy and unable to transmit diseases (such as the infamous kuru).

My mind wandered into other hypothetical scenarios. What about swallowing semen: would that fit the definition of cannibalism? If eating human tissue is sometimes acceptable as in placentophagia, when does it become not acceptable and why? Would it be acceptable to eat surgical specimens of healthy tissue? For instance, a healthy uterus that had been removed only because of prolapse, or breast tissue from breast reduction surgery? Circumcised foreskins? Unused tissue from a phallus removed during sex-change surgery? Not that anyone has suggested eating those things, but it’s interesting to think about where reasoning might lead us once we have accepted a principle. Socrates was famous for that: he would get his interlocutors to agree to a statement and then would make them explore the logical consequences that would necessarily ensue.

Some vegetarians make an exception for placentas. One writer on Yahoo! Answers justified placentophagia by rationalizing that she eats eggs and placenta is basically human egg white!

My personal preference? I didn’t eat my placentas because I saw no reason to do so, but I don’t object on principle. Even if placentophagia qualifies as cannibalism, I don’t see any rational objection to cannibalism per se, as long as it doesn’t involve unethical practices like murder. I have an aversion to raw meat, but I wouldn’t have any objection to eating placenta if it were cooked and seasoned. With the high blood content, I imagine it would taste somewhat similar to the fried (bovine) blood I enjoyed eating when I lived in Spain. Fried blood tastes something like liver and is delicious when prepared with garlic and olive oil.

Forgive the digression and the weird speculations.

Is It Recycling?

The placenta contains a lot of nutrients and could help replace the nutrients depleted during pregnancy, especially iron. This might be important for some animals; but for humans who have adequate access to food, these nutrients are easily replaced through more conventionally accepted means. It seems a shame for good nutrients to be thrown away. On the other hand, recycling placental nutrients would have only a very small impact. Most of us don’t feel an obligation to recycle everything. We throw away other nutrients by discarding the outer leaves of cabbages and the fat trimmings from cuts of meat. A fanatical recycler might accept recycling as a compelling reason for placentophagia, but I suspect that most people wouldn’t be persuaded by that argument alone.

What Health Benefits Are Claimed?

According to Placentabenefits.info, health claims include:

  • Increase general energy
  • Allow a quicker return to health after birth
  • Increase production of breast milk
  • Decrease likelihood of baby blues and post natal depression
  • Decrease likelihood of insomnia or sleep disorders
  • Other benefits are also likely but too numerous to mention.
  • “Definitely worth considering as part of a holistic postpartum recovery for every expectant woman.”

Dried human placenta is also used in traditional Chinese medicine (TCM) to treat wasting diseases, infertility, impotence, and other conditions.

Is there scientific support for those claims?

The Placentabenefits website offers the following scientific research to support those claims:

  1. A 1954 article from Czechoslovakia showed that taking a supplement derived from placenta increased milk production, but after 57 years this study has still not been replicated. This same study is mentioned by the authors of the second reference only to question it, characterizing it as “a somewhat unrigorous study”
  2. “Placentophagia: A Biobehavioral Enigma” discusses animals and human cultures that practice placentophagia and ponders why. It provides no data directly relevant to the claims for human health.
  3. A study of opioid levels in rats after placenta ingestion, showing that placenta enhances y- and n-opioid antinociception, but suppresses A-opioid antinociception — in rats. No apparent relevance to their claims for human benefits.
  4. A 1980 study showing that placentophagy alters hormone levels in rats. It didn’t even look at what clinical effects might result from those altered levels.
  5. They cite an article without giving sufficient clues for me to be able to locate it. By their description, the article apparently cites research by Chrousos suggesting that lower levels of human corticotrophin releasing hormone (CRH) after delivery might be a possible etiology for postpartum depression; but it says nothing about treatment or the effects of eating the placenta.
  6. An article showing that iron deficiency anemia affects postpartum emotions and cognition, with no discussion or evaluation of whether eating placenta elevates serum iron levels significantly or improves emotions or cognition.
  7. An article about predicting postpartum depression by assessing postpartum fatigue. Nothing about eating placenta.
  8. Unexplained fatigue may benefit from iron supplementation. Nothing about eating placenta.
  9. A discussion of why postpartum iron deficiency should not be overlooked. No mention of placentas.

My own search of PubMed didn’t uncover any relevant studies on humans. If these 9 articles are their best effort, they’re grasping at straws. All they’ve got is rats and speculation. The best they can do is to mention the need for adequate iron and speculate that placenta-eating might be a useful source of iron. To counter that, we know enough about iron metabolism to make us think it is highly implausible that a one-time ingestion of placenta would contribute very much to effectively replenishing the body’s iron stores.

Conclusion

Science does not offer sufficient evidence to either support or reject placentophagia as a health practice. Nonscientific considerations will continue to determine women’s choices in this matter.

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Ethics in human experimentation in science-based medicine

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Science-based medicine depends upon human experimentation. Scientists can do the most fantastic translational research in the world, starting with elegant hypotheses, tested through in vitro and biochemical experiments, after which they are tested in animals. They can understand disease mechanisms to the individual amino acid level in a protein or nucleotide in a DNA molecule. However, without human testing, they will never know if the end results of all that elegant science will actually do what it is intended to do and to make real human patients better. They will never know if the fruits of all that labor will actually cure disease. However, it is in human experimentation where the ethics of science most tend to clash with the mechanisms of science. We refer to “science-based medicine” (SBM) as “based” in science, but not science, largely because medicine can never be pure science. Science has resulted in amazing medical advances over the last century, but if there is one thing that we have learned it’s that, because clinical trials involve living, breathing, fellow human beings, what is the most scientifically rigorous trial design might not be the most ethical.

About a week ago, the AP reported that experiments and clinical trials that resemble the infamous Tuskegee syphilis study and the less well known, but recently revealed Guatemala syphilis experiment were far more common than we might like to admit. As I sat through talks about clinical trial results at the Society of Surgical Oncology meeting in San Antonio over the weekend, the revelations of the last week reminded me that the intersection between science and ethics in medicine can frequently be a very tough question indeed. In fact, in many of the discussions, questions of what could or could not be done based on ethics were frequently mentioned, such as whether it is ethically acceptable or possible to do certain followup trials to famous breast cancer clinical trials. Unfortunately, it was not so long ago that such questions were answered in ways that bring shame on the medical profession.

More than Tuskegee and Guatemala

The most notorious of highly unethical human experiments outside of Nazi Germany and the Japanese empire during World War II is the infamous Tuskegee syphilis study. This study, conducted by our very own Public Health Service (PHS) was conducted between 1932 and 1972 and examined the natural progression of untreated syphilis in poor black men who received free health care from the government. In 1932, when this study was conceived it was not inherently unethical. At the time there were precious few treatments for syphilis, and none of them worked very well. Consequently, observing the progression of syphilis, using the treatments available at the time, and following the subjects prospectively constituted a reasonable trial design. However, in the late 1930s and early 1940s, penicillin became available, and by 1947 was the standard of care for treating syphilis. When campaigns to eradicate syphilis came to the county in which most of the subjects, study researchers prevented their subjects from participating. In essence, even after an effective treatment for syphilis had become widely available, study still researchers denied it to their subjects. By the end of the study in 1972, of the original 399 men in the study, 28 had died of syphilis; 100 were dead of related complications; 40 wives had been infected with syphilis; and 19 children had been born with congenital syphilis. The rationale for not providing effective treatment for these men and even discouraging them from undergoing such treatment? This:

Such individuals seemed to offer an unusual opportunity to study the untreated syphilitic patients from the beginning of the disease to the death of the infected person. An opportunity was also offered to compare the syphilitc process uninfluenced by modern treatment, with the results attained when treatment had been given.

Worse, there was no informed consent, and considerable inducements were offered to the men to join the study.

The Tuskegee syphilis study, unfortunately, is not the only abuse committed by the PHS. About six months ago, it was revealed that these sorts of experiments had been more widespread than commonly believed. Indeed, in the 1940s in Guatemala, the PHS had gone one better in that they had deliberately infected prison inmates in Guatemala with syphilis. As I described in a lot more detail when the revelations first hit the press, prostitutes who had tested positive for syphilis were recruited to visit the men in prison. The hypothesis to be tested was whether prophylactic penicillin treatment could prevent infection, and the other purpose was to define the response of syphilis to penicillin treatment. Again, there was no real informed consent. Worse, subjects were intentionally infected with a potentially fatal disease. True, they were treated, but treatment is not 100% effective, and one has to wonder if the prisoners, a vulnerable population, understood the nature of the risks they were being induced to take.

On Sunday, AP medical writer Michael Stobbe published a long article detailing the sordid history of medical research in the U.S. before the 1970s. His timing was not coincidental, because on Tuesday in Washington, DC, there was a meeting of a presidential bioethics committee, the Commission for the Study of Bioethical Issues, triggered by the revelations last fall about the Guatemala syphilis experiment 65 years ago. Those revelations led the AP to do an exhaustive review of reports from medical journals and press clippings, and the AP found at least 40 studies similar to the Guatemala syphilis study in that patients were put at risk for serious disease or, even worse, healthy people were intentionally made ill to study disease. Some of these abuses are well known, others much less so.

Here are some examples from the AP article:

The AP review of past research found:

  • A federally funded study begun in 1942 injected experimental flu vaccine in male patients at a state insane asylum in Ypsilanti, Mich., then exposed them to flu several months later. It was co-authored by Dr. Jonas Salk, who a decade later would become famous as inventor of the polio vaccine.

Some of the men weren’t able to describe their symptoms, raising serious questions about how well they understood what was being done to them. One newspaper account mentioned the test subjects were “senile and debilitated.” Then it quickly moved on to the promising results.

  • In federally funded studies in the 1940s, noted researcher Dr. W. Paul Havens Jr. exposed men to hepatitis in a series of experiments, including one using patients from mental institutions in Middletown and Norwich, Conn. Havens, a World Health Organization expert on viral diseases, was one of the first scientists to differentiate types of hepatitis and their causes.

A search of various news archives found no mention of the mental patients study, which made eight healthy men ill but broke no new ground in understanding the disease.

  • Researchers in the mid-1940s studied the transmission of a deadly stomach bug by having young men swallow unfiltered stool suspension. The study was conducted at the New York State Vocational Institution, a reformatory prison in West Coxsackie. The point was to see how well the disease spread that way as compared to spraying the germs and having test subjects breathe it. Swallowing it was a more effective way to spread the disease, the researchers concluded. The study doesn’t explain if the men were rewarded for this awful task.
  • A University of Minnesota study in the late 1940s injected 11 public service employee volunteers with malaria, then starved them for five days. Some were also subjected to hard labor, and those men lost an average of 14 pounds. They were treated for malarial fevers with quinine sulfate. One of the authors was Ancel Keys, a noted dietary scientist who developed K-rations for the military and the Mediterranean diet for the public. But a search of various news archives found no mention of the study.
  • For a study in 1957, when the Asian flu pandemic was spreading, federal researchers sprayed the virus in the noses of 23 inmates at Patuxent prison in Jessup, Md., to compare their reactions to those of 32 virus-exposed inmates who had been given a new vaccine.
  • Government researchers in the 1950s tried to infect about two dozen volunteering prison inmates with gonorrhea using two different methods in an experiment at a federal penitentiary in Atlanta. The bacteria was pumped directly into the urinary tract through the penis, according to their paper.

The men quickly developed the disease, but the researchers noted this method wasn’t comparable to how men normally got infected — by having sex with an infected partner. The men were later treated with antibiotics. The study was published in the Journal of the American Medical Association, but there was no mention of it in various news archives.

Stobbe goes on to point out the “Holy Trinity” of news stories in the 1960s and early 1970s that brought to light the sorts of activities that we now consider abuses in medical research. The last of these was, of course, the Tuskegee syphilis study. The first of these occurred in 1963, when it came to light that researchers had injected cancer cells into elderly debilitated patients at the Jewish Chronic Disease Hospital in Brooklyn to discover whether their bodies would reject them. With our knowledge of tumor immunology now, we can look back on this experiment and know that the odds of any harm were quite small because tumors, with very, very rare exceptions, are not transplantable in humans. Our bodies recognize cells from another person to be foreign, whether they are cancer or not, and quickly destroy them. However, at the time, based on what was known, undoubtedly the scientists thought that there was at least a chance that these tumor cells would form cancers in the patients into whom they were injected, the denial of the hospital director who deemed the cells “harmless,” notwithstanding. (Indeed, the hospital director strikes me as either lying or deluded.) Otherwise, why seek to answer the question? Just as bad, there was no informed consent, the justification being that the cells were thought to be “harmless.” More details can be found here. The outcome was that the Board of Regents censured the researchers and suspended the licenses of two of the doctors involved. Later, however, they stayed the suspensions and instead put the doctors on probation for one year. There were no repercussions for the hospital or for Memorial Sloan-Kettering Cancer Center, where one of the investigators was on faculty.

The third of the “Holy Trinity” was an infamous experiment in Staten Island at the Willowbrook State School, which was a school for children with mental retardation. During the mid-1960s, children there were intentionally infected with hepatitis in order to determine whether gamma globulin could cure it. Besides the targeting of a vulnerable population (children and teens with profound mental retardation), this study demonstrated a number of problematic issues as well. First, the investigators rationalized infecting these children by rationalizing that hepatitis was so endemic in the facility due to the fact that most of the children there were incapable of being toilet trained that over 70% of new residents became infected within a year. This, of course, leads to the obvious question, namely: If that were the case then why not study the effect of gamma globulin on children who were infected normally? More disturbing, again investigators played fast and loose with informed consent, the form being worded in a vague and ambiguous manner that played down the fact that the children were going to be intentionally infected with hepatitis and implying that the serum they would be given would be an experimental vaccine. Finally, as is the case in many such studies, there was an element of coercion. Willowbrook at the time was very crowded, with long waiting lists for children to be admitted. At times, there was only room in the experimental wing. For parents who could not afford to take care of their children, this situation could bring considerable pressure to bear to “persuade” them to “do the right thing.”

Changing ethics

In studying the history of medicine and clinical trials, what never ceases to amaze me is the different attitudes that physicians and scientists had towards their human subjects not all that long ago. Remember, it was primarily in the 1960s and 1970s when attitudes began to change. Before the 1970s, for instance, researchers thought little of using prisoners for experiments, even though prisoners are correctly considered a population that is vulnerable and for whom true informed consent without coercion is difficult to obtain without special attention to making it happen. Indeed, in his news story Stobbe recounts an anecdote of a man at Holmesburg Prison in Philadelphia who agreed in exchange for cigarette money to have the skin peeled off of his back and searing chemicals painted on the open wounds in order to test a drug. Similarly, as the Willowbrook story shows us, it was not really all that long ago when scientists apparently felt justified in infecting profoundly mentally retarded children with hepatitis on the basis of at best dubious ethical justification.

Arguably, this willingness to experiment on children who were not normal and who were never going to be able to contribute to society was a holdover from the eugenics movement earlier in the 20th century. It’s important to remember that, however much eugenics was discredited by the Nazis, prior to the Holocaust Hitler was actually quite the admirer of American eugenics policies, drawing inspiration from them. Another factor that is frequently invoked as an explanation for the willingness of American scientists to flout ethical considerations is war, particularly World War II and then the Cold War, the resulting idea that it was “us against them,” and that for us to win would require shared sacrifice in the name of the nation. After all, the scientific primacy of the U.S. was viewed as one of the most critical sources of our economic and military strength. Moreover, the concept of the Cold War could be generalized to other “wars,” such as the “war on disease” or the current “war on cancer” that I’ve written about twice in the last month. As Stobbe put it:

Attitudes about medical research were different then. Infectious diseases killed many more people years ago, and doctors worked urgently to invent and test cures. Many prominent researchers felt it was legitimate to experiment on people who did not have full rights in society — people like prisoners, mental patients, poor blacks. It was an attitude in some ways similar to that of Nazi doctors experimenting on Jews.

“There was definitely a sense — that we don’t have today — that sacrifice for the nation was important,” said Laura Stark, a Wesleyan University assistant professor of science in society, who is writing a book about past federal medical experiments.

There was clearly also more than a little hubris at play as well:

It was at about this time that prosecution of Nazi doctors in 1947 led to the “Nuremberg Code,” a set of international rules to protect human test subjects. Many U.S. doctors essentially ignored them, arguing that they applied to Nazi atrocities — not to American medicine.

Finally, with the rise of large pharmaceutical companies in the 1940s and 1950s, increasingly there was more of a profit motive than a purely scientific one. Drugs needed to be tested, and prisoners provided a convenient source of young, healthy men upon which to test new products. Hubris, profit, and a wartime attitude that sacrificing for the good of the nation all swirled together into a mixture toxic to medical ethics during World War II and well into the postwar period. In having defeated the Nazis, we failed to learn a lesson from what had happened in Germany, where one of the most technologically and medically advanced societies then on the face of the earth did horrible things in the name of its ideology.

Yes, it is true that American scientists did not intentionally expose prisoners to freezing water in experiments designed to find better ways of rewarming pilots shot down over frigid waters or sailors who survived the sinking of their ship, as Nazi doctors did. It is also true that American scientists did not intentionally irradiate men’s testicles and women’s ovaries in order to develop a means of rapid sterilization, causing horrific bowel and bladder complications, especially in women, as Nazi scientists did, although American scientists did subject many to various radioactive substances in the name of research. Nor did American scientists inject dyes into the eyes of children in order to try to turn them blue, as Dr. Mengele did. On the other hand, American scientists did, as we have seen, intentionally infect prisoners and mentally retarded children (the same sort of children that the Nazis would have called “life unworthy of life”) with diseases and then treat them, just as Nazi physicians intentionally infected concentration camp inmates with various diseases in order to determine the efficacy of different treatments or as Japanese physicians did when they intentionally broke the limbs of prisoners and contaminated them with bacteria-laden dirt. American offenses were different in scale and horror, but not significantly different in kind. Unfortunately, it was not until the 1970s, years after the international Helsinki Declaration was first published, until the Belmont Report was adopted and then not until the 1990s when The Common Rule became the basis of all federal regulations protecting human research subjects, as I have described before.

Could it happen again?

Fortunately, as one who now participates in clinical trials and clinical trial development, given the current level of regulation on human subjects research by the federal government, I have a hard time imagining how abuses such as the one’s I’ve described could happen again now. The amount of paperwork, regulation, and oversight of clinical trials has become so burdensome and complex that sometimes I wonder why I or anyone else would want to continue doing clinical research. Unfortunately, Stobbe doesn’t sound too optimistic. Actually, it’s not so much Stobbe, but rather the presidential Commission for the Study of Bioethical Issues, as Stobbe documents in a followup story:

Speakers noted that over the last several decades, as many as 1,000 rules, regulations and guidelines have been enacted worldwide to ensure the ethical conduct of medical research. In the United States, there are rules to protect people in every study done by federal scientists, funded by federal agencies or those testing a product requiring federal approval to be sold.

But that oversight is inconsistent — ethical rules can vary among federal agencies. What’s more, if federal funding or review is not involved, an unethical study could be done and no one in authority would ever know about it.
“We have a leaky system,” said Eric Meslin, director of the Indiana University Center for Bioethics.

Dr. Robert Califf, Duke University’s vice chancellor for clinical research, agreed there are weaknesses.

“It’s night and day and what you could do in the ‘good old days’ with no one knowing about it. But there’s no 100 percent guarantee. There still will be bad things that will happen,” he said.

In terms of pharmaceutical companies, there are clearly loopholes when it comes to overseas studies. Indeed, pharmaceutical companies have been doing more and more studies overseas. Although federal law states that such studies, if they are funded by the federal government or if they are to be used as part of an application for FDA approval of a drug, that is not always enough of a guarantee of oversight:

Last year, the U.S. Department of Health and Human Services’ inspector general reported that between 40 and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008, and that proportion probably has grown. The report also noted that U.S. regulators inspected fewer than 1 percent of foreign clinical trial sites.

Clearly, this is an unacceptable level of oversight, particularly outside of developed countries, such as those in Europe, where clinical trial oversight is comparable to that in the U.S.

Ironically, two examples come to mind of clinical trials that show the holes in our regulatory system for human subjects protection, both of which I have written about right here on SBM before. The first trial was a trial of homeopathic remedies for infants with infectious diarrhea in Honduras, as I wrote about here and Wally Sampson wrote about here. At the time I couldn’t figure out how the investigators at the University of Washington managed to get this study through their IRB, but somehow they did, demonstrating that an IRB is not a guarantee against the approval of totally unethical and scientifically worthless experiments. Fortunately, as far as I can tell, no infant was injured, but the potential was definitely there. Then, let’s not forget the Gonzalez trial, a trial of a regimen of what can best be described as pure quackery consisting of up to 150 supplement pills a day, various nutritional pseudoscience, and daily (or more) coffee enemas. The results were devastating, in that subjects on the standard-of-care chemotherapy arm lived three times longer than those on the Gonzalez protocol arm. Such is the effect of the National Center for Complementary and Alternative Medicine (NCCAM) on research ethics.

The more disturbing example is Mark and David Geier, the father-son tag team of anti-vaccine activists who fervently believe that mercury in vaccines causes autism and somehow came up with an idea that can only be described as dangerously wacky, namely that by suppressing testosterone with a powerful drug (Lupron) they could make the quackery known as chelation therapy “work better” at chelating mercury from the brains of autistic children. The reason? Because “testosterone sheets” bind mercury and keep it from being chelated! In pursuing this research, the Geiers have created an IRB stocked with their cronies and fellow anti-vaccinationists to “oversee” the research, as Kathleen Seidel has so thoroughly documented. In the process, autistic children were subjected to a powerful drug that depresses their sex hormone levels, which is why its use is often referred to as “chemical castration.” Predictably, Anne Dachel, Media Editor over at the anti-vaccine crank blog Age of Autism, has leapt all over this story as “evidence” that vaccines must be dangerous and that unethical scientists have been lying all along about the science showing tthat there is no evidence that vaccines cause autism:

Either Stobbe is a naïve and trusting soul and can’t consider that the same government that allowed horrific medical experiments in the past also allowed our children to become vaccine guinea pigs, or he’s afraid of an issue that’s just too controversial to talk about here and now. It’s much safer to attack what went on in the last century.

Maybe 70 years from now, some enterprising reporter will bring up the ethics of injecting known neurotoxins in pregnant women, babies, and small children.

Maybe around 2080, they’ll ask why no one ever demanded independent studies on the cumulative effect of so many vaccines, so soon, on the health of a baby. Or why there was never a simple vax-nonvax comparison study looking at autism rates.

Or maybe in 2050, Dachel will understand that this is the sort of work that’s been replicated so many times and done in so many different countries that even if you were to throw out all the U.S. data it wouldn’t change the conclusion that vaccines do not cause autism. She also overlooks the fact that the vast majority of the studies that have failed to find a link between vaccines and autism were performed after the adoption of the Common Rule and much-increased federal oversight over clinical trials. Of course, stories like Stobbe’s make it easier for cranks to attack the entire U.S. clinical research enterprise as corrupt and unethical. However, that is not the reason why we need to close the loopholes in our current clinical trial regulations. We need to do it because it is the right thing to do.

We at SBM argue that medicine should be based on science, rather than be a science, because we realize that medicine can never be completely scientific. There are too many human variables, not the least of which are patient values, individual patient situations, and resources. Another reason is the clinical trial process itself. Sometimes the most scientifically rigorous clinical trial design is not the most ethical design; indeed, sometimes it might be downright unethical. One example is, as I have pointed out, the aforementioned study of vaccinated versus unvaccinated children that seems to be every anti-vaccine activist’s most fervent dream. The most scientifically rigorous design for such a study would be a randomized, double-blind, placebo-controlled trial. However, such a trial would leave half of its participants completely unprotected against potentially deadly childhood infectious diseases, making it totally unethical to perform, even if it could be scientifically and fiscally justified based on existing preliminary data, which it really cannot.

Perhaps a better example is how placebo-controlled trials have almost gone the way of the dodo in cancer chemotherapy trials. Most oncology trials are now designed to test a new drug against the current standard of care or the new drug plus the standard of care versus standard of care alone. This is because our ethical considerations have evolved such that we now no longer consider giving placebos to cancer patients to be ethical unless there truly is no existing effective treatment for their cancer or if we truly do not know if the proposed treatment is better than observation alone and observation alone is currently the standard of care. As I have described before, in clinical trials, there must be clinical equipoise; i.e., based on the scientific evidence as it is known at the time the trial begins, a reasonable scientific assessment of the risks and benefits must conclude that the risks to the experimental group are either minimal or outweighed by the potential benefits. Here’s another thought to chew on. Experiments in which people were intentionally exposed to infectious agents and then subjected to various treatments to cure the disease thus caused are potentially the most scientifically rigorous way of all to test such treatments in humans because they allow control of the start of the infection, the amount of bacteria injected, and many other variables that can’t be so easily controlled in “wild” cases of infectious disease. However, because such experiments violate the precept of, “First, do no harm,” they are utterly unethical and now properly condemned by any physician with a shred of ethics. That we should require laws, rules, and regulations to prevent such unethical experiments by scientists is unfortunately, but scientists are no different than any other person. Not all of them are ethical; some are completely unethical. Some can be corrupted.

There will always be unethical scientists, at least as long as there are unethical people. That’s why we need laws to protect human subjects. However, we must also remember that the protection of human subjects is a balancing act. Go too far in the direction of lax regulation, and incidents such as those described in Stobbe’s article will start to happen again. Go too far in the other direction, and the pace of discovery will grind to a halt. Key to finding the balance is to respect patient autonomy and to provide true informed consent that accurately balances risks versus benefits and to protect patients from any form of coercion. Doing so without making the clinical trial process so onerous that researchers flee the field while at the same time protecting patients from foreseeable harms will be the challenge.

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