Tuesday, April 26, 2011

Of All Things That Are Wrong...

... the one I am going to describe really takes the cake: Australia-based Homeopathy Plus! is advocating the use of homeopathy to prevent and protect against meningococcal diseases. This is not merely burning, incandescent stupidity, but potentially lethal as well.

The Gram-negative bacterium Neisseria menigitidis (commonly known as meningococcus) is the etiological agent for meningococcal disease.1 This disease usually manifests as bacterial meningitis (occurring in ~50% of all cases), and may often be associated with rapidly progressing sepsis syndrome. Characterized by a sudden onset and rapid progression, meningococcal disease has a high case fatality rate (~9-12% in the US), even when early and appropriate therapy is instituted. The symptoms may range from simple (headache, pyrexia, nausea/vomiting, general malaise) to progressively serious neurological sequelae (neck rigidity, neurologic deficits, loss of auditory functions), which occurs in 11-19% of patients.

The meningococcal bacteria colonize mucosal surfaces inside the nose (nasopharynx); they are transmitted from person to person through direct contact with droplets of respiratory secretion (nasal discharge, sneeze) from those with existing disease or asymptomatic carriers. Humans are the only host, and almost all human meningococcal disease in the US is caused by 5 of the 13 identified serogroups: A, B, C, W-135, and Y.1

Use of conjugate vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b in the most vulnerable group (i.e. infants) has dramatically reduced the incidence of infections by these bacteria in the US, thereby leaving meningococcus as the leading agent of bacterial meningitis and septicemia. Currently, the annual incidence of meningococcal disease in the US is ~1500-3000 cases, and the annual disease rate in recent years ranges from 0.9-1.5 cases per 100,000, with the greatest incidence being among infants <1yr of age (9.2 cases per 100,000, accounting for ~16% of all cases). Adolescents and young adults, despite a lower incidence, have a greater case fatality rate [Reviewed in 1].

Not surprisingly, vaccines against meningococcus can potentially provide the maximum protection. In order for the vaccine to be effective in meningococcal disease, it should induce high titers of circulating antibodies to prevalent serogroups of meningococcus. Of the 5 major serogroups, serogroup A, responsible for major outbreaks globally, is on the wane in the US - where serogroups B, C and Y, and to a minor extent, W-135, account for majority of cases. Serogroups have age-specific occurrences also: in infants and toddlers, serogroup B accounts for the greatest percentage of disease, while A, C, Y, and W-135 combined still account for more than 50%; B, C and Y in ages 18-34yrs, and Y in seniors.

Current armamentarium against meningococcus in the US includes two quadrivalent (A, C, Y, W-135) vaccines vaccines - a polysaccharide meningococcal vaccine (licensed for individuals 2yrs+) and a polysaccharide-protein conjugate meningococcal vaccine; the conjugate vaccine (approved for active immunization in individuals aged 2-55 yrs) is primarily recommended, because unlike the polysaccharide vaccine, it is able to elicit immune memory, confer long-lasting immunity, and significantly reduce in nasal carriage of meningococcus. Unfortunately, no vaccine is licensed in the US for prevention of meningococcal disease in infants & toddlers (<2yrs, the most vulnerable age group).

A 2001 CDC analysis revealed that a combined approach of immunizing infants, adolescents, and college students at entry with the conjugate vaccine may demonstrate the greatest impact in terms of number of cases and deaths prevented;2 therefore, a multivalent vaccine effective for infants is a significant unmet medical need. The existing conjugate vaccine is poorly immunogenic in infants; however, investigational vaccines with slightly different conjugation partners have shown enhanced immunogenicity in the age range of 2 months-65yrs in clinical trials.1 Currently, candidate vaccines based on outer membrane vesicles (surface components) containing strain-specific protein antigens - which could ensure broad geographic coverage - as well as those active against Serogroup B are being researched and a few candidates have shown benefit in outbreak control in some countries (Norway, New Zealand, Cuba).3

With me so far?

This is the space that the homeopaths seek to sic themselves into. Noble goal, undoubtedly. But what are they bringing to the table? Let's take a look.

They do a decent job in defining the problem, the deadly nature of the meningococcal disease in a paragraph. But the moment they start talking about the available vaccines, their usual shenanigans emerge. Look at the way their phrasing goes.

There are 13 strains of Meningococcal disease but only two available vaccines.

Ooh! 13 strains - big scary number; only two vaccines. Never mind that only about 5 of the strains are majorly implicated in human disease, 4 of the 5 being vaccine preventable, the remaining one being worked upon. Huh.

Anyhoo. The floodgate of nonsense opens thereafter. They go on to make some pretty bold claims:

Knowing the seriousness of meningococcal disease and the lack of a complete vaccine against it, is there an another way of protection? Homoeopaths would say, "Yes - homoeopathic Meningococcinum."

They even compare their nostrum with vaccines.

While vaccines have to be matched to the individual strains of a disease, homeopathic prophylactics are matched to the disease symptoms and not the name... Because symptoms are the same from one meningococcal strain to another, the one remedy can be used for all. For this reason, protection is possible for even the 'B' strain...

Yeah. The Germ Theory of Disease - however empirically-established, well-tested, and founded on solid scientific principles - can go climb a tree. And here is the gem:

Ignorance about it ("Meningococcinum") in most Western countries means only those 'in the know' get to use it.

I know. The homeopathic 'elite', procuring their nostrum in a clandestine fashion after secret handshakes and whatnot.

So, by this time, I was hooked, and was eagerly looking forward to the extraordinary evidence from their studies supporting their extraordinary claims. Ooh! Ooh! They even mentioned two recent studies in Brazil that showed 'efficacy' of Meningococcinum.

A quick look at the references indicated that the Brazilian studies were dated 1975 and 1998/99. A tad old, but the journals must be solid - given the importance of the problem. Yeah, well. The journals were (a) Journal of the American Institute of Homeopathy, 1975 Dec 68 (4), 211-219; and (b) Homeopathic Links, Vol 14 Winter 2001, 230-234. How very... quaint. And obscure.

In a different context about the outrageous, unsupported claims of the homeopaths, bloggers and valiant pseudoscience battlers apgaylard and jdc325 have mentioned the first paper. The second paper apparently follows the first "study". These are not listed in PubMed (of course!). The only text I could find were abstract pages from a Google search; one odd little site even indicated that the study in Brazil was halted just after a year. I wonder why. Various homeo-aficionado websites are curiously short of actual raw data, and regurgitate the same abstracts over and over. The evidence for efficacy of a homeopathic nosode is still wanted and unavailable.

Meningococcinum, a so-called homeopathic 'nosode', is supposedly a mix of cultures of various serogroups of the meningococcus (the second Brazilian study apparently used a sick patient's bodily fluids as source), diluted to 10C (10010), 30C (10030), or more, beyond the limits of plausibility. Any remnant of the bug - hell, any molecule of any solute, for that matter - is long gone, but the diluent, water, magically retains the memory of the bug, and the memory is supposed to confer protection. Like many alternative medicine practitioners who crave the legitimacy of science and evidence-based medicine, homeopaths, too, are adept at appropriating the language from clinical disciplines. Therefore, "protection" immediately conjures up an image of a vaccine-like, prophylactic activity - thereby pushing the homeopaths to refer to the nosode quackery as 'homeoprophylaxis'.

So, here we are talking about a serious, often fatal, infectious disease with severe complications, albeit one that is largely vaccine preventable in most populations - and homeopaths are peddling an unscientific, implausible, magical remedy that is good for absolutely nothing, let alone prevent or treat a disease. That is the most dangerous aspect of this quackery. I can't imagine subjecting infants and toddlers to this nonsense; that would be reckless child endangerment.

The site, Homeopathy Plus!, also advocates the use of homeopathic Belladonna in case of an existing meningococcal disease! Not antibiotics, but magic sugar water. I wonder if Australia has existing laws under which these websites can be sued for defrauding consumers and preying upon the vulnerabilities of patients and their families through false advertising.

Frankly, it sickens me.

Further reading:

1. Reisinger et al. Clin Pediatr, 2010; 49: 586-597.

2. Lingappa et al. Vaccine, 2001; 19:4566-4575.

3. Van Alphen and van den Dobbelsteen. Human Vaccine. 2008; 4:158-161.

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