Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a somewhat nebulous diagnosis with unknown etiology and no effective treatment. To make the diagnosis, bacterial infection must be excluded and the symptoms must last at least 3 months. Symptoms include pain in various locations (between rectum and testicle, in the testicles, at the tip of the penis, in the lower back, in the abdomen over the pubic or bladder area), pain or burning with urination, frequent urination, pain or discomfort during or after sexual climax. There are also systemic features like decreased libido, myalgias, and fatigue, and there is a higher incidence of chronic fatigue syndrome in these patients. The connection to the prostate is uncertain; in one study, women with chronic pelvic pain reported more of these symptoms than men did. Diagnosis is based on self-reported symptoms; there are no objective diagnostic markers. Somewhere between 2 and 10% of the male population are reported to suffer from this syndrome.

Since there is no effective mainstream treatment for this disorder, why not try acupuncture? Two randomized, placebo-controlled studies have reported positive results from acupuncture treatment. Is this enough evidence for us to recommend it to patients?

The Malaysian Study

This well-designed study was done in Malaysia, in a hospital with traditionally trained acupuncturists on its staff, in conjunction with the University of Washington Department of Urological Surgery. It was funded by the NIH and published in the American Journal of Medicine. There were 90 subjects randomized into two groups. They compared acupuncture at traditional points to sham acupuncture with more superficial needling 15 mm to the left of traditional points. They used no adjunctive treatments. They minimized interaction between participants and acupuncturists. They looked for a primary endpoint of a 6 point decrease from baseline to week 10 in a validated scale of symptoms, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and for secondary outcomes including complete resolution and decreased scores at other intervals. They treated twice weekly for 30 minutes for 10 weeks, then followed the patients for an additional 24 weeks. They tested blinding by asking participants which therapy they thought they had received: 95% of those receiving acupuncture and 82% of those receiving the sham treatment thought they had received acupuncture. They found that acupuncture was twice as effective as sham acupuncture for the primary endpoint (73% vs. 48%, p=0.02) at 10 weeks, that more acupuncture patients had complete resolution of symptoms (18 vs. 10, p=0.07), and that acupuncture recipients had a greater long-term response 20 weeks after completing therapy (32% vs. 13%, p=0.04).

The Korean Study

The other study was done in Korea and was published in the journal Urology. It was a three-arm study comparing advice and exercise (A & E) alone to A&E plus electroacupuncture (where the acupuncture needles were electrically stimulated) to A&E plus sham acupuncture. There were only 13 men in each group. The sham acupuncture involved (1) more superficial needling, (2) placement 15 mm to the left of acupuncture points, and (3) the sound of the pulse generator without actual electrical stimulation. In the acupuncture group they found a significant reduction in the NIH-CPSI scores for pain, but no reduction in the scores for urinary symptoms or quality of life. On another scale, the International Prostate Symptoms Score, there were no significant differences. There is no mention of an exit poll to see if patients could guess which treatment they had received.

This study had one other intriguing wrinkle. There had been some hints of a correlation between prostatitis symptoms and prostaglandin E and beta endorphin levels, so they measured these in post-massage urine samples. They found a significant decrease in prostaglandin level in the electroacupuncture group (p=0.023) and a non-significant increase in the other two groups. They present a bar graph that makes it look like the increase in the sham group was more significant than the decrease in the electroacupuncture group, but they don’t provide the raw data or even report calculated p values, so we can only guess what the bars mean.

There was no significant change in endorphins for any group. It’s intriguing that they were able to measure something objective, but at this point, without replication, it’s impossible to say what the data mean, if anything.

Other Studies

A PubMed search for “clinical trials, chronic prostatitis and acupuncture” brought up these two studies and only 5 others that were a mish-mash of different kinds of prostatitis and different treatments: warm needle moxibustion, suspended moxibustion (where a burning stick is held above the acupuncture point with no skin contact), abdominal cluster needling, sometimes in association with herbal enemas and other treatments. A meta-analysis of case-control studies out of China found a significantly higher cure rate with acupuncture than with controls, but they were looking at studies of a different diagnosis: chronic prostatitis, not chronic prostatitis/chronic pelvic pain syndrome. And none of the studies were randomized controlled trials.

Additionally, the Korean study referenced another study that did not come up on my PubMed search for some reason. This study of CP/CPPS involved three sets of acupuncture points totaling 30 points (8 points were electrically stimulated) given alternatively twice weekly for 6 weeks. It showed an even more impressive effect: 83% of subjects reported marked improvement, but it was an uncontrolled pilot study with only 12 subjects.

So we don’t have a lot of evidence, but the evidence we do have consistently supports acupuncture for CP/CPPS. Acupuncturists can say their treatments are evidence-based.

Discussion

As you may have guessed, I have some reservations. In the first place, what do they mean by acupuncture? The Malaysian study used 4 acupuncture points: CV1, CV4, SP6 and SP9. The Korean study used acupuncture points BL 32, Bl33, GB30 bilaterally, for a total of 6 entirely different points. The Malaysian study used only needle insertion; the Korean study used electrical stimulation. The pilot study used 30 points with electrical stimulation of 8 of them. If you were going to do acupuncture based on these studies, which points would you choose?

Studies can’t really support each other if they’re not testing the same treatment, can they? In addition, even the Malaysian study was not a test of acupuncture per se. The “true” acupuncture arm did not even attempt to elicit the “de qi” sensation that many acupuncturists consider essential to the acupuncture effect. They followed a rigid protocol rather than offering the kind of individual treatment adjustments acupuncturists typically use in practice. And they did not twirl or stimulate the needles in any way after insertion. If their results had been negative, they might well have argued that their study didn’t discredit acupuncture because it didn’t represent the practice of acupuncture at all.

More importantly, we need to look at these studies in the context of everything else we know. Good studies with better controls (retracting needles) have shown no difference between acupuncture points and non-points. Other studies with toothpicks and with simple electrical transcutaneous stimulation have shown that it doesn’t matter whether the skin is penetrated. So many studies have shown sham acupuncture to be equal to “true” acupuncture that in several recent studies acupuncturists themselves have chosen not to use a sham acupuncture control on the theory that it is not a placebo control because any skin stimulation is effective. (But then what is acupuncture??!!) And even the best studies are not double blind: double blind studies would be extremely difficult to design, since the acupuncturist is aware of what he is doing.

Another concern is that studies from Asian countries are prone to the “file drawer effect” where negative studies are filed away rather than submitted for publication. This is a bigger problem in Asia than elsewhere: 98% of published acupuncture trials from Asia are positive, versus 30% of acupuncture trials from Canada, Australia and New Zealand. What if most of the evidence is really negative? What if 4 studies were done, 3 with negative results and one with positive results, and only the one with positive results was submitted for publication? Replication in a country with a better track record would make the results more credible.

We know there are many things that can go wrong with experiments, and that most published research findings are false. When initial findings are mixed for a treatment that really works, there is a gradual accumulation of more convincing data that tips the balance over time. Acupuncture studies have never shown any such progress.

I will admit to being prejudiced by the fact that acupuncture is based on pre-scientific thinking and on points, meridians and vitalistic forces whose existence can’t be demonstrated. But we wouldn’t have to know “how” it worked if it clearly “did” work. The evidence is inconsistent and not robust enough to convince rigorous scientists that acupuncture is more effective than placebo for any medical condition.

A Question Rather Than a Conclusion

Since medical science has little to offer for CP/CPPS, is recommending acupuncture ethically justified; and if so, should patients be told it is evidence-based?

A common theme in alternative medicine is the “One True Cause of All Disease”. Aside from the pitiable naivete, it’s implausible that “acidic diet”, liver flukes, colonic debris, the Lyme spirochete, or any other problem—real or imagined—can cause “all disease” (in addition to the fact that most of these ideas are intrinsically mutually exclusive).

One of the popular new ideas in this category is that of “endocrine disrupting chemicals” (EDCs). These are chemicals in the environment that physiologically or chemically mimic naturally occurring human hormones. That some environmental substances are chemically similar to human hormones is indisputable. That these substances can have a real physiologic effect in vitro seems to hold up. How much of an effect these chemicals may have in real human populations is an open question.

And unlike many similar ideas, there are a lot of plausible questions that are under investigation. And this is where I fear our colleagues in the media lose it. The media can be an effective source of public health information, even a tool to improve public health, but when the media unleashes a torrent of premature speculation, science and the public health lose. This is where the Times’s Nicholas Kristoff comes in. On Sunday, he asked these questions:

The battle over health care focuses on access to insurance, or tempests like the one that erupted over new mammogram guidelines.

But what about broader public health challenges? What if breast cancer in the United States has less to do with insurance or mammograms and more to do with contaminants in our water or air — or in certain plastic containers in our kitchens? What if the surge in asthma and childhood leukemia reflect, in part, the poisons we impose upon ourselves?

We have many examples of human-made environmental chemicals causing disease.  Often, a cluster of disease is identified, and then a common exposure is found, and further study confirms a likely causal relationship.  For example, in the 20th century, thousands of people in Minamata, Japan fell ill and died from a mysterious neurological ailment.   Investigation found that industrial methyl mercury contamination had entered the seafood chain  and was the responsible agent.

Conversely, suspect contaminated regions can be identified, and then clusters of disease can be sought.  This is a bit trickier, but still a legitimate way of investigating a relationship.  The Michigan PBB incident in one such example in which health effects were hard to nail down.  Cigarette smoking as a cause of cancer was a bit more clear.

A less effective way to approach this type of problem is to have neither a clear disease cluster nor a clear exposure group.  This is the mistake made by Kristoff.  He relates EDCs to several problems, but focuses on breast cancer, drawing a line from EDCs to early puberty, to longer time from menarche to menopause, to increased breast cancer rates.  While this is not implausible, it’s pretty damned tenuous.  In order to see if EDCs are really causing breast cancer in significant numbers, we should establish both a correlation between exposure to specific chemicals and excess cases of breast cancer. We should also have a laboratory model for the connection.

The problem here from a science-based medicine perspective is not the implausibility but the oversimplification and naive, hyperbolic conclusions.  Kristoff cites a 56-page report from the Endocrine Society, which was much more circumspect and called for further study of the issue.  I can understand the desire to communicate an important health story to the public, but choosing an emotionally charged issue like breast cancer and linking it to everyday substances that everyone uses blurs the issue more than it clarifies.  It incites emotion without asking clear, important questions.

When I’ve talked to experienced public health experts about EDCs, they’ve given me a noncommittal, “yeah, there could be something to that,” but none that I’ve read have been willing to call this a major public health threat.  We know the causes of lots of cancers.  We know how to screen for many important cancers, which allows for early detection and treatment.  Some cancers we can actually prevent by limiting environmental exposures;  many lung cancers could be prevented by eliminating exposure to cigarette smoke.   Whether any cancers can be prevented by banning putative EDCs is a question that’s barely been asked, much less answered.

Lose weight without diet or exercise? I guess that leaves cancer.

It is the day after Thanksgiving, and I have probably eaten enough calories to support the average family for at least three days. I am hesitant to comment on what my actual weight may be, but others have not been so reticent about discussing my appearance over at RDCT. At least I am not female; then I would get no end of critiques based on my looks.

Now that I am up a few holiday pounds, it would be nice to lose some weight. Of course I do not want to do it the old fashioned way, with diet and exercise. Diet and exercise take time and are fundamentally painful. I want to eat what I want when I want from the comfort of my Lazy Boy. I want an easy way to lose weight. The interwebs, as is often the case, have been kind enough to provide me with numerous emails suggesting all sorts of simple ways to alter my physique for the better, some of which even include weight loss.

For some reason I have been on a spam list that keeps me well supplied with offers to try acai berry juice to lose weight.

Acai is a palm tree whose fruit, like that of many palms, is a food source for the indigenous peoples in the area where they grow. The akai berry is grape sized and purple and if it is purple it must be good. Of late acai has been touted for a wide number of health benefits, including weight loss, because it is believed to be high in antioxidants.

How do antioxidants help you lose weight?

According to the weight loss center antioxidants can help with weight loss as follows

“The reality is that antioxidants may very well improve weight loss or, at the very least help provide the body with the nutritional support it needs to keep it strong and energized during the fat burning process.

To help you understand how antioxidants can enhance weight loss, you need to take a closer look at the actual process that occurs when we lose fat. While most people tend to look at fat as their enemy when they are overweight, it is imperative that you realize fat is necessary for our health. There are two types of fat:

1. Essential fat – necessary for many body functions including reproduction.
2. Storage fat – Essential for protecting some of the body’s organs.

The fat in our bodies is stored in our adipose tissue. This tissue contains lipids that are needed to transform nutrients into energy. Fat cells have many functions and one of them is to store toxins that are released throughout the digestive process. Thus, when you reduce the fat in your body, the amount of toxins in your body increases and this can result in some negative side effects. For instance, the extra toxins often affect the liver, causing it to work overtime to process and remove them. Moreover, when fat molecules are broken down, a process called oxidation, they release free radicals, which can result in cell, protein and DNA damage.

Oxidation occurs when free radicals (unstable atoms) attack cells to re-stabilize themselves. The re-stabilized atoms release more free radicals and the process continues like a chain reaction throughout the body until the free radicals are stopped. The body will create its own antioxidants to help stop the reaction, but often there is not enough, which is why ingesting foods or supplements rich in antioxidants can be beneficial.

Thus, when you lose weight, you are not only shedding excess fat, you are also losing some of the nutrients in your body that are needed to maintain good health. Also, if you are exercising as part of your healthy weight loss program then your body will be creating even higher levels of toxic by-products. Therefore, antioxidants can help provide your body with the nutritional support it requires during the oxidation process, reducing the stress on your body and keeping energy levels and metabolism as high as possible.”

Huh? So as best as I can tell from this tortuous explanation, antioxidants contribute to weight loss by nutritional support. It appears the the purpose of antioxidants is not so much to help stimulate weight loss but to act like a catalytic converter, taking off the ‘toxins’ generated by fat oxidation. Just where these anti-oxidized toxins then go is never mentioned. This is one of the more coherent explanations I have found. My rule of thumb is that if a product provides support and is not an undergarment, it is crock.

Is there data to support the use of any antioxidants to help with weight loss? Not that I can find. Although there are many interweb claims that antioxidants help with weight loss, Pubmed and Google Scholar are silent on the topic. So despite the common use of supplements as an adjunct to weight loss, there is nothing to support the use of antioxidants, in acai or other foods, in weight loss.

Ironically, there is at least one study to show that antioxidants may help with weight gain in AIDS and cancer, although I doubt the increase in weight was due to any antioxidant properties of the supplements. Antioxidants may also prevent some of the beneficial effects of exercise as well. The take home message, as is often the case in medicine, is that the effects of supplements on physiology are rarely simple or straightforward.

So antioxidants have no role in weight loss outside of an advertising gimmick.

Back to acai. From Google trends, acai juice seems to be a relatively new fad in the US. Searches for the product stated in volume in the middle of July, 2008. While association is not causation, it is worth noting that the big spike in Google searches occurred shortly after Dr. Oz mentioned acai on Oprah

The Oprah mention apparently spawned the acai industry with the inadvertent help of Dr. Oz and Oprah, who are now suing the acai companies for using their likenesses and for implying that Oz and Oprah were supporting acai and using their good name. Do not mess with Oprah and suggest she gives your product a seal of approval.

The other industry spawned at the time was the acai scam, where people will sign up for ‘free’ acai using their credit card for shipping and handling, and then get charged large sums and be unable to cancel the order. Do NOT order acai online. If you are going to purchase worthless products, buy them at your local supplement store.

Like silver or other supplements, there is also a growth industry in the real acai, as opposed to all the posers who are peddling second rate products. One of the more important features of quality acai is the ORAC levels. Really. Orac. Go figure. But I do prefer high levels of Orac. The most amusing part of the acai industry is that the model used in many of the websites for ‘before’ and ‘after’ is a photo-shopped iStockphoto who never used the product. I wonder if the second rate acai products leads to photo-shopped weight loss.

“There are no magical berries from the Brazilian rainforest that cure obesity—only painfully real credit card charges and empty weight loss promises,” said Connecticut Attorney General Richard Blumenthal. “Aggressive Acai berry pitches on the Internet entice countless consumers into free trials promising weight loss, energy and detoxification. These claims are based on folklore, traditional remedies and outright fabrications—unproven by real scientific evidence. In reality, consumers lose more money than weight after free trials transition into inescapable charges. We will investigate these allegedly misleading or deceptive nutrition and health claims and take action under our consumer protection statutes—as we have done with other food products.”

This is the same Blumental who sued the Infectious Disease Society of America for anti-trust for their Lyme treatment guidelines, so I doubt it is a deep understanding of science and medicine that guides his actions.

So is there anything at all to acai as a way to lose weight? Perhaps.

Eating the fruit straight from the tree may give you Chaga’s, a parasite that destroys your heart and esophagus, rendering you unable to eat, so you might lose weight that way. Hardly seems worth it. Analysis of the fruit does show it has vitamin C and a variety of antioxidants, so it is not bad for you. But there are more palatable alternatives:

“ PJ (pomegranate juice) had the greatest antioxidant potency composite index among the beverages tested and was at least 20% greater than any of the other beverages tested. Antioxidant potency, ability to inhibit LDL oxidation, and total polyphenol content were consistent in classifying the antioxidant capacity of the polyphenol-rich beverages in the following order: PJ>red wine>Concord grape juice>blueberry juice>black cherry juice, açaí juice, cranberry juice>orange juice, iced tea beverages, apple juice. Although in vitro antioxidant potency does not prove in vivo biological activity, there is also consistent clinical evidence of antioxidant potency for the most potent beverages including both PJ and red wine.”

Is there anything special from acai? I am uncertain and unenthusiastic. It is safe to say, if you have ever had a Bordeaux, that the Connecticut Attorney General was only partly wrong, that magic berries can be found in France. There is nothing special about acai except the hype.

If you are not interested in spending money on acai juice, I found a more direct way to rid your self of 10 pounds of ugly, unwanted fat. Rather than have the fat go away from metabolism, inject it away. Maybe I can be rid of the turkey and gravy with mesotherapy. What is mesotherapy? It is

“ a minimally invasive technique that consists of the intra- or subcutaneous injection of variable mixtures of natural plant extracts, homeopathic agents, pharmaceuticals, vitamins, and other bioactive substances in microscopic quantities through dermal multipunctures.”

Minimally invasive is correct, as the needles used in mesotherapy are 3 mm long.

Mesotherapy has a curious origin, oddly familiar to those who wander the fringes of medicine.

In 1952 a French physician, Michel Pistor, treated a man with asthma with IV procaine, an anesthetic, and while it did not help the patients asthma, it did improve the patients hearing, DD Palmer be praised. Dr Pistor at that point decided to inject the procaine superficially around the ear, and while it did not restore hearing in other patients, others had improvement in their temporal-mandibular joint pain syndrome, eczema, and tinnitus.

Of course, this therapy was a panacea, not limited to treating hearing loss, but used for treating systemic problems with local superficial injections. Dr Pistor said ‘‘the action on tissue originating from the mesoderm is so extensive that these treatments deserve the global name of mesotherapy’’ and a new branch of medicine, at least in France, was launched.

The list of diseases treated with mesotherapy is extensive:

‘Allergies, arthritis, asthma, carpal, tunnel, syndrome, cellulitis, chronic, fatigue, constipation, degenerative, disc, disease, depression, fibromyalgia, gout, headache, hearing, loss, hemorrhoids, hepatitis, herpetic, neuralgia, immune, system, deficiencies, insomnia, irritable, bowel, syndrome, lower, back, pain, lymphedema, obesity, osteophytes, (‘‘bone, spurs’’), peripheral, vascular, disease, prostatitis, reflex sympathetic, dystrophy, sports injuries, (i.e.,, sprains,, strains, tears,, bursitis,, tendonitis, plantar, fasciitis, calcium, deposits), substance, abuse, temporal-mandibular, pain, syndrome, tinnitus, and vertigo.”

A large numner of diseases require a remarkable number of substances to be injected with mesotherapy, not limited to

“ T3-T4 thyroid, isoproterenol, aminophylline, pentoxifylline, l-carnitine, l-arginine, hyaluronidase, collagenase, yohimbine, lymphomyosot, co-enzyme cofactors, dimethylethanolamine, gerovital, glutathione, tretinoin, alpha lipoic acid, vitamin c, procaine, lidocaine, ginkgo biloba, melilotus, c-adenosine monophosphate, multiple vitamins, phosphatidylcholine, trace mineral elements, and carbon dioxide” and more as well as homeopathic preparations.

Mesotherapists choose their injectables for their alleged effects, for example injecting an NSAID for anti-inflammatory effects or artichoke (really) for circulatory stimulation. Often multiple substances are mixed together, based on the experience of the mesotherapist, rather than data, into a cocktail that is then injected.

There are less than a dozen articles in the European medical literature to support the use of mesotherapy for medical conditions such as pain and musculoskeletal conditions and have the same rigor as acupuncture studies.

In the US mesotherapy is used primarily for cosmetic changes and body sculpting, but also to ‘dissolve fat’ and treat cellulite. Its efficacy is debated as evidenced by one review entitled “Cosmetic mesotherapy: between scientific evidence, science fiction, and lucrative business.”

The plastic surgery literature often states that mesotherapy is not the same as using injections of phosphatidylcholine and deoxycholate to remove superficial fat, for which there is some supporting literature. Histopathology after phosphatidylcholine and deoxycholate injections demonstratess an inflammatory response with fat necrosis, and there may also be some fat necrosis from traditional mesotherapy products as well .

Part of determining if mesotherapy can lyse fat is defining what constitutes mesotherapy, what kind of fat you are trying to eradicate and, with what are you injecting. One patient, with congenital large symmetrical fat collections was treated with good cosmetic effect with injections of phosphatidylcholine, but many would not consider this mesotherapy since the phosphatidylcholine was injected deep into the fat.

Whether similar or other injections are beneficial for cellulite or other superficial fat depositions cannot be determined; the data to date is minimal and suggests it is without efficacy. Unfortunately mesotherapy is worthless for the turkey induced muffin top. It can run thousands of dollars and, to judge from sites not promoting mesotherapy, it is both painful and useless. Many who use ‘CAM’ seem to like to ‘do it yourself’, but I would advise against home mesotherapy with lipase .

Mesotherapy is not FDA approved, but since the products are (except, I suppose, for artichoke) FDA approved medications, they can be used off label by mesotherapists.

While efficacy is uncertain and cost is variable, what is well described are the complications. There are numerous outbreak reports of infections with atypical mycobacteria, cousins of Tb, that cause long term scarring. Not unsurprisingly, some of the outbreaks are due, in part, to the practitioner not using standard sterile technique.

“Fourteen patients reported breaches in safe-injection practices by the practitioner, including 1) failure to practice hand hygiene, 2) failure to prepare the skin with an antiseptic, 3) failure to wipe vials with alcohol before injection, and 4) failure to wear gloves. Of 11 patients who could recall, all reported use of a new needle; however, nine patients reported use of a multidose vial. Patients reported being told their injections contained various substances (e.g., plant extracts from artichoke and thuja, liquid “graphites,” and procaine). With the exception of procaine, none of the substances reported by patients have been approved for subcutaneous injection by the FDA. ”

Mesotherapy is also associated with care reports of other odd reactions including thyrotoxicosis, septic arthritis, and a variety of local skin reactions. I wonder if I were to get a mesotherapy injection with acai juice…

I suppose I am still stuck with diet and exercise.

Go Ducks.

Its authors boast that it is one of the ten most downloaded papers from the British Medical Journal (BMJ). That makes it even more unfortunate that the conclusions of the paper are directly at odds with the findings of the paper. Outcomes of planned home births with certified professional midwives: large prospective study in North America by Kenneth Johnson and Bettye Ann Davis is the premier paper on the safety of American homebirth. It claims to show that homebirth is as safe as hospital birth, but actually shows that homebirth has nearly triple the neonatal death rate of hospital birth for comparable risk women.

Johnson and Daviss, in collaboration with the Midwives Alliance of North America (MANA), the organization of American homebirth midwives, collected data on all homebirths attended by Certified Professional Midwives (CPMs, homebirth midwives, as distinct from CNMs, Certified Nurse Midwives) in the year 2000. Then the authors compared the outcomes for interventions and for neonatal deaths with a hospital group.

According to Johnson and Davis, when analyzing the different intervention rates of home and hospital:

We compared medical intervention rates for the planned home births with data from birth certificates for all 3 360 868 singleton, vertex births at 37 weeks or more gestation in the United States in 2000, as reported by the National Center for Health Statistics [Births: final data for 2000. National vital statistics reports. Martin JA, Hamilton BE, Ventura SJ, Menacker F, Park MM. Hyattsville, MD: National Center for Health Statistics, 2002;50(5)]

They used singleton, vertex births at 37+ weeks as a proxy for low risk women. They found, not surprisingly, that intervention rates are lower for homebirth. Then they turned to neonatal mortality rates. They should have compared the neonatal mortality rate of the homebirth group to the neonatal mortality rate of the hospital birth group, but they did not. Instead, they compared homebirth deaths to hospital births in a variety of out of date studies extending back more than 20 years.

The authors conclude:

Planned home birth for low risk women in North America using certified professional midwives was associated with lower rates of medical intervention but similar intrapartum and neonatal mortality to that of low risk hospital births in the United States.

But the authors never compared mortality rates to low risk hospital birth in 2000, because that would have led to a very different conclusion. Using the same dataset that Johnson and Daviss used, we find hospital neonatal death rate for white,  babies at 37+ weeks of 0.9/1000. This is not corrected for congenital anomalies, pre-existing medical conditions, pregnancy complications or multiple births. The neonatal mortality rate for white, singleton babies at 37+ weeks is 0,72/1000. The true rate is substantially lower. Nonetheless, we can make an important comparison. Johnson and Daviss reported a neonatal death rate at homebirth of 2.7/1000 (uncorrected for congenital anomalies, breech or twins). In other words, the neonatal death rate of CPM attended homebirths in 2000 was nearly triple the rate for low to moderate risk hospital births in 2000.

Simply put, the authors pulled a bait and switch. They claim to be comparing homebirth in 2000 with hospital birth in 2000. Indeed, they are comparing intervention rates for homebirth in 2000 with hospital birth in 2000, but when it comes to neonatal deaths, they used data extending back to 1969. It was the only way to make homebirth look safe by comparison.

Why might the authors deliberately intend to deceive readers? It turns out that Johnson and Daviss are not impartial researchers, though you would not know that from reading the paper. Johnson is the former Director of Research for the Midwives Alliance of North America (MANA) Statistics and Research Committee. Daviss, his wife, is a homebirth midwife. The paper does acknowledge that the study was funded by Foundation for the Advancement of Midwifery, a homebirth advocacy group.

Johnson and Daviss have created a website, Understanding Birth Better, to answer criticism. However, their explanation for the bait and switch is not merely disingenuous, it is an outright lie.

… Since our article was submitted for publication in 2004, the NIH has published analysis more closely comparable than was available at that time, and some have tried to use it as a comparison. While we still do not offer the comparison as a completely direct one, … it is the closest we have …

As they say in politics, it’s not the crime, but the cover up. Johnson and Daviss acknowledge that they used the wrong group for comparison with homebirth, but claiming that the correct data was not available at that time. That is flat out false.The relevant data was published in 2002, long before their paper was submitted (Infant Mortality Statistics from the 2000 Period Linked Birth/Infant Death Data Set, published August 29, 2002). Moreover, even before publication of the analysis, Johnson and Daviss had the raw data in their possession. They used that raw data from 2000 to calculate the rates of hospital interventions, so they were fully aware of the mortality data at all times.

It is difficult to imagine a legitimate reason why a professional statistician would deliberately use the wrong statistics for comparison when the right statistics were available and actually in his possession. It seems to me that the only possible explanation is that they knew all along that their study showed that homebirth has an increased risk of preventable neonatal death compared to hospital birth.

Regardless of reasoning or excuses, the bottom line is stark: rather than showing that homebirth with an American homebirth midwife is safe, the Johnson and Daviss study actually showed that homebirth with a CPM in 2000 had nearly triple the neonatal death rate of moderate to low risk hospital birth in 2000.

While doctor visits for influenza-like illnesses seem to be trending downward again, and ”swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.

There is no scientific evidence that thimerosal in vaccines poses any risk to children,  pregnant women, or their fetuses. In fact, the evidence contradicts the claims by the anti-vaccine lobby that thimerosal in vaccines is a cause of autism. On a multitude of levels there is ample reason to reject any link between thimerosal and autism:

1. All of the legitimate studies to date have failed to demonstrate any link.

• Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data
• Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
• Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
• Safety of Thimerosal Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

2. The apparent increase in autism cases has continued even after the removal of thimerosal from vaccines.

• Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data
• Continuing Increases in Autism Reported to California’s Developmental Services System: Mercury in Retrograde
• Pervasive Developmental Disorders is Montreal, Quebec, Canada: Prevalence and Links with Immunizations

3. Finally, and a usually neglected part of the story, the kind of mercury contained in thimerosal (ethylmercury) is very different from the kind produced by industrial pollution, and that ends up in the fish you eat (methylmercury). While methylmercury becomes concentrated in the body’s tissues (most importantly the brain) and thus remains for prolonged periods, ethylmercury is much more rapidly eliminated, and is therefore much less readily stored by the body. Recent studies have demonstrated just how different the pharmacokinetic properties of these two types of mercury are in the bodies of infants. This is important when we consider the US EPA “reference dose” (RfD) for mercury. This is the upper level daily amount, over a lifetime, of a substance that is considered safe to the most sensitive individuals in a population. The RfD for mercury set by the EPA is 0.1 micrograms per kilogram of body weight per day. Many people who believe the thimerosal-autism link point to the fact that, before thimerosal was removed from vaccines, some infants received a total daily dose of mercury from vaccines that came close to or exceeded the EPA’s RfD for mercury. Keep in mind, however, that the RfD was based on long-term, life-time daily exposures, not one time or even multiple time exposures. Also, as a safety factor the RfD was set 10 times higher than the actual estimated safe level. But most importantly, the RfD for mercury is based on data for methylmercury, not ethylmercury. That is, all the assumptions about the hypothetical dangers of exceeding the RfD for mercury, on potentially a few occasions, are based on an RfD for the wrong kind of mercury. As discussed above, the data on the pharmacokinetics of ethylmercury suggests a very different, and far less concerning picture for thimerosal in vaccines.

But let’s return to the legislation at hand. Besides their inclusion under this thimerosal ban, what else is exceptional about pregnant women and children under the age of 3? Well, they happen to be at greatest risk for serious complications of H1N1 disease, and are considered to be the highest priority populations for receipt of the vaccine. So, ironically, those at greatest risk for severe morbidity and mortality from the disease, and who are at the top of the list for getting the vaccine, aren’t permitted by law to receive it. Until, that is, states began issuing emergency waivers of these absurd laws.

To be fair, written into the law is a provision for the Comissioner of Public Health to waive the law during times of vaccine shortage or in the event of a severe outbreak. The important point, however, is what the very existence of these laws reveals about the power of the anti-vaccine lobby and a fear-stoked constituency. The fact that 7 states have enacted laws banning thimerosal-containing vaccines, and that there is similar legislative activity occuring in several other states, is a testament to the power of fear over reason, and the struggle of science to gain a foothold in our national consciousness. Although California has also temporarily waived their thimerosal ban, California’s secretary of Health and Human Services, Kim Belshe, issued this dark-aged rejoinder,

We take very seriously the expressed concerns that mercury in vaccines causes autism and remain committed to full implementation of [the law]

One of the greatest dangers of this trend away from a scientific view of medicine, and toward a more individualistic or even democratic one, is the solidification of this group think into the bedrock of legislation. The legislative process, shaped by constituencies, lobbies, and the personal leanings and beliefs of legislators, is frighteningly susceptible to irrational and anti-scientific forces. Glaring examples of this can be seen in the enactment of the Dietary Supplement Health and Education Act of 1994, the formation of the National Center for Complementary and Alternative Medicine in 1998, the establishment of Title V, Section 510 of the Personal Responsibility and Work Opportunity Reconcilitation Act (A.K.A. abstinence only education) in 1996, and the numerous insurance equality laws most states have enacted to mandate insurance coverage of chiropractic treatemnts, and other so-called “CAM” providers. This last type of legislation is particularly concerning. The newly formed Institute for Science in Medicine is currently working to address stealth provisions in health care reform legislation, now being debated in the Senate, that seek to legitimize “CAM” practitioners and mandate insurance coverage for a wide array of medically invalidated treatments. If this legislation is passed, more anti-science will be foisted upon our nation’s system of health care.

A quote from the recent New York Times review of Michael Specter’s new book, “Denialism“, sums up this trend toward “giving the people what they want” in health care. Although democracy is a wonderful way to run a nation, it isn’t how we develop science-based medicine.

…for better or worse, people are more skeptical of authority than they used to be and want to think for themselves, which includes grappling with the minutiae of science. Not so long ago, for example, patients rarely questioned doctors before undergoing surgery or taking their pills (for example, estrogen replacement therapy to prevent heart attacks), a blind obedience to authority that arguably cost many more lives than, say, vaccine refusal does now. What we are seeing is the democratization of science…

Many parents of children with autism have expressed to me their dismay that the anti-vaccine lobby is sucking all the oxygen out of the room for autism awareness. They feel that just being a parent of a child with autism makes others assume that they are anti-vaccine. They also worry that resources and attention are being diverted from promising legitimate research because of all the attention being paid to the failed vaccine hypothesis.

So it is good to occasionally focus on mainstream autism research to show that progress is being made, despite the unfortunate anti-vaccine sideshow.

A recent study published in the latest issue of Pediatrics shows that early intervention in toddlers with autism can have significant benefits. The study is a randomized controlled trial of  the Early Start Denver Model compared to conventional treatment in 18-30 month old children with a diagnosis of autism spectrum disorder (ASD). The study is a reasonable size for this kind of intervention – 48 children were randomized – and this is sufficiently powered to get statistical significance. But it should be noted this is still a smallish study and replication to confirm the results is welcome.

Another potential weakness is that the control group was “referral to community providers for intervention commonly available in the community.” Therefore the control group was not standardized and it’s possible this group was sub-optimally treated. Further, while the groups were randomized they were not blinded.

The results of the study are quite robust:

Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD: 15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group.

The results of this study are plausible and encouraging, and hopefully will lead to further studies to confirm the results.

The concept behind ESDM is this (from the EarlyDevelopment Studies Lab website):

Autism impedes this process of child learning and adult scaffolding, in several ways.  Children with autism are less attentive to other people and so miss many learning opportunities by watching. Young children with autism have impaired communication skills, so they have difficulty learning from the communications that adults provide. Young children with autism also have difficulty imitating others, and so miss opportunities to learn by copying what others do. Young children with autism may not be quite as flexible in their play skills as others, and may enjoy repeating favorite actions with objects, rather than generating new play ideas and learning through discovery, and this limits their learning. And finally, young children with autism may not find social experiences as inherently rewarding as other children, which can result in reduced time in interactions of all sorts. Since interactions are a primary learning opportunity for toddlers, fewer interactions mean fewer learning opportunities.

The ESDM is designed to make learning for young ASD toddlers more fun, dynamic, and child-directed rather than repetitive. The purpose is to compensate for the specific areas of difficulty of ASD children.

While not a “cure” if these results hold up ESDM can be a very effective early intervention for children with ASD. It highlights the potential benefit of early detection and intervention programs.

It also brings to mind the broader context (which is relevant to many neurological diseases and disorders) that at times focus on finding a cure might overshadow research and even clinical attention paid to interventions that improve quality of life and mitigate the impact of a disorder. Finding a cure is, of course, always the long term goal. But we have to be realistic in recognizing that for many complex disorders it is a very long term goal. Meanwhile there is much that can be done to significantly improve outcome, and these types of interventions should not be neglected simply because they are not a “cure.”

Patients and families need to recognize that often there is much that can be done, and they should not neglect medical attention under the false belief that “nothing can be done” simply because a cure does not exist yet. Sometimes, even clinicians need to be reminded of this fact.

Also, research priorities should reflect a reasonable balance between searching for a cure and improving outcomes in the meantime. Grassroots advocacy groups that raise funds for clinical research, in my opinion, often over-emphasize research that has the potential to find a cure in the short term, and may in fact slow overall research progress by upsetting the balance between various kinds of research (basic, therapeutic, and symptomatic).

So it is good to see a solid symptomatic trial like this one get attention, and to remind people that we can make a significant difference with science-based interventions in the lives of children with ASD, even if we don’t fully understand the disorder or know how to cure it.

Nasal irrigation with salt water is recommended by 87% of family doctors as an adjunctive treatment to relieve the symptoms of nasal congestion and sinusitis. The simplest method is to hold salt water in your cupped hand, block one nostril while you inhale the water into the other nostril, then blow your nose. The high-tech version is to use a Neti pot, a little jug with a spout. You pour the salt solution from the Neti pot into one nostril and it drains out the other nostril. The technique is described here.  

The Neti pot originated in India in Ayurvedic medicine. Neti is Sanskrit for “nasal cleansing.” Other related ancient techniques that have not been adopted by scientific medicine include using a string instead of water and a yoga technique where you close one nostril, pour the solution into the other nostril and allow it to run out of the mouth. 

Nasal irrigation provides short-term symptomatic relief and may improve nasal mucociliary clearance. It removes mucus not only from the nose but also from the maxillary and ethmoid sinuses.  

A randomized controlled trial in 2002 found that daily hypertonic saline nasal irrigation improves sinus-related quality of life, decreases symptoms, and decreases medication use in patients with frequent sinusitis.  Its effectiveness is supported by a Cochrane review.  

A recent review article in American Family Physician  gave nasal irrigation an “A” strength of evidence rating as an effective adjunctive therapy for symptoms of chronic rhinosinusitis, and  a “B” rating for irritant and allergic rhinitis and viral upper respiratory infections. 

Just don’t overdo it. A new study presented at the annual meeting of the American College of Allergy, Asthma and Immunology in November 2009 found that while short-term nasal irrigation is therapeutic, long-term use of nasal irrigation is harmful. Regular users of irrigation who continued using it had an average of 8 episodes of recurrent rhinosinusitis per year, while those who discontinued it only averaged 3 episodes per year.  The investigators hypothesized that the nasal mucosa serves as the first line of defense, and irrigation depletes the nose of its immune blanket of mucus, thereby increasing the risk of recurrent infection.

I’ve been writing about the attempts of proponents of various pseudoscience, quackery, and faith-based religious “healing” modalities to slip provisions friendly to their interests into the health care reform bill that will be debated in the Senate beginning today. If you want to know what’s at stake, check out the first press release of a newly formed institute designed to promote science-based medicine in academia and public policy, the Institute for Science in Medicine.

It’s an embryonic institute, only recently formed by 42 physicians and scientists, several of whose names will be quite familiar to regular readers of SBM, but it’s jumping right into the fray. This is what the ISM is:

The ISM is a non-profit educational organization dedicated to promoting high standards of science in all areas of medicine and public health. We are a watchdog group of medical professionals who believe the best science available should be used to determine health policy and establish a standard of care that protects and promotes the public health. We oppose legislation that seeks to erode the science-based standard of care and expose the public to potentially fraudulent, worthless, or harmful medical practices or products.

Given how when faced with science going against them purveyors of unscientific medicine and medical beliefs try to win in politics where they can’t win in science (as my earlier post today describes for naturopaths in Ontario and the anti-vaccine movement in Oregon), just as we do on SBM, those of us who have helped to form the ISM have our work cut out for us.

Steve Novella has more.

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.

Naturopaths prescribing drugs?

I’ve never been able to figure out why naturopaths want to gain the power to be able to prescribe pharmaceutical drugs to patients. I really haven’t. After all, the entire philosophy of naturopathy as “finding and treating the cause of chronic problems, not just treating symptoms,” “letting nature heal,” and “treating the whole person,” whatever that means. Indeed, here’s what the American Association of Naturopathic Physicians says about naturopathic medicine:

First, do no harm. Naturopathic physicians follow three precepts to ensure their patients’ safety:

• Use low-risk procedures and healing compounds—such as dietary supplements, herbal extracts and homeopathy—with few or no side effects.
• When possible, do not suppress symptoms, which are the body’s efforts to self-heal. For example, the body may cook up a fever in reaction to a bacterial infection. Fever creates an inhospitable environment for the harmful bacteria, thereby destroying it. Of course, the naturopathic physician would not allow the fever to get dangerously high.
• Customize each diagnosis and treatment plan to fit each patient. We all heal in different ways and the naturopathic physician respects our differences.

Natural Standard defines a naturopath thusly:

Naturopathy is the practice of the use of natural substances to provide a healthier balance of internal chemistry.

A naturopath is a therapist who practices naturopathy. Naturopathic physicians (NDs) are primary healthcare practitioners. Naturopathic physicians are the highest trained practitioners in the broadest scope of naturopathic medical modalities. In addition to the basic medical sciences and conventional diagnostics, naturopathic education includes therapeutic nutrition, botanical medicine, homeopathy, natural childbirth, classical Chinese medicine, hydrotherapy, naturopathic manipulative therapy, pharmacology and minor surgery. Naturopathic practice excludes the use of most synthetic drugs and major surgery.

Naturopathic medicine is a natural and holistic approach to health and healing that recognizes the integrity of the whole person. Many treatment methods are used, including nutrition, herbs, manipulation of the body, exercise, stress reduction, and acupuncture.

It is not difficult to find naturopaths writing critical screeds against “big pharma” and the supposed evils of “allopathic medicine,” or the dismissal of “allopathic medicine” or “biomedicine” (one can almost see the sneer on the lips of the author writing that) as:

Human control over nature is characteristic of all Western Thought, including allopathic medicine. Since Descartes, matter has been considered separate from the spirit and the physical body, as part of matter, must be controlled for its own good. A physician is taught a “stewardship” view of the body that parallels society’s “stewardship” view of nature. It is well-intentioned, yet based on an attitude of control and domination. This is not to say that Biomedicine1 does not have its place. Rather, as we re-evaluate our relationship to the environment, we must necessarily re-evaluate our health care. “The ancient formula of one ill, one pill, one bill, which seems to have been the credo of physicians for many generations should be abandoned…Disease cannot be understood without an ecological study in depth [that includes] the environment, the host, and the culture”. Naturopathic medicine provides an alternative philosophy to Biomedicine that embodies environmental principles. These ecological tenets include finding deeper solutions than a technological fix, valuing diversity, accepting human limitations, trusting the Healing Power of Nature, and considering the ecosystem as a whole.

So why on earth would naturopaths want to prescribe pharmaceutical agents? It makes little sense, yet that is exactly what naturopaths are lobbying for in Ontario, as has been documented by Scott Gavura in the National Post and in the blog Skeptic North and Steve Thoms, as well as by our very own PalMD, Mark Crislip, and David Kroll. Worse, it appears that Ontario is poised to do just that and grant prescribing powers to naturopaths.

This would be a recipe for disaster. As we have discussed here many times, the key concept behind naturopathy is not scientific and the current movement for “naturopathic physicians” is in reality a resurrection of a 19th century health movement espousing the “healing power of nature.” Rather, at the heart of most naturopathic practices is primitive vitalism, a belief that has existed for hundreds, if not thousands, of years that there is a “life force” that can be manipulated for healing effect, an “energy” that modern medicines do not help. Many ancient health concepts derived from vitalism, such as the idea that disease is due to an imbalance of the “four humors.” It is the same concept behind reiki, acupuncture, and therapeutic touch, all of which are accepted and practiced by naturopaths. Another key belief behind naturopathy is that many diseases are due to “contamination” with “toxins,” which is why much of naturopathy concerns itself with “detoxification” regimens. Indeed, naturopathy is, more than anything else, a grab bag of virtually every implausible, unscientific, or even outright disproven “alternative” modality out there. It is not uncommon to see naturopaths offering colon cleanses, reiki, acupuncture, chelation therapy, and all manner of supplements. No woo is beyond the pale. Indeed, homeopathy is one major bit of quackery that is embraced by naturopaths.

Worse, as Scott Gavura and PalMD have argued, naturopaths do not have the knowledge base to be able to prescribe drugs safely. Indeed, Peter Lipson showed that quite conclusively when he issued a “primary care challenge” and quite correctly likened naturopathy for hypertension to “modern shamanism.” Their claims of treating the “whole patient,” notwithstanding, they do not have an adequate knowledge of how drugs work, what the potential side effects might be, or how various drugs might interact with each other or with the various supplements that naturopaths are fond of using. However, as we have seen in the past, pseudoscientific movements are nothing if not persistent and patient. After the Ontario government repudiated recommendations to allow naturopaths to prescribe drugs, the naturopaths are back and on the verge of persuading the Ontario legislature to give them what they want, as puzzling as it may be why they want it, given how much in conflict naturopathic philosophy seemingly is with “allopathic medicine.”

Maybe naturopaths have figured out that they can only go so far prescribing placebo medicine and ineffective modalities that can be outright dangerous, like chelation therapy and colon cleanses.

The anti-vaccine movement and “greening” Oregon’s vaccines

A less well-known but even more potentially dangerous example of purveyors of pseudoscience trying to influence government laws and policy is the anti-vaccine movement. It’s had some success and caused a great deal of mischief by successfully planting two of its own (Lynn Redwood, President of SafeMinds, and Lee Grossman, president and CEO of the Autism Society of America, both of whose organizations buy into the scientifically discredited notion that vaccines cause autism) on the Interagency Autism Coordinating Committee (IACC), where they have caused great mischief by constantly lobbying for a study of “vaccinated versus unvaccinated” children and in general trying to push the idea that vaccines cause autism, all helped by another anti-vaccine zealot, Mark “I’m a serious scientist, really” Blaxill, MBA, who blogs for Age of Autism. It’s also possible that anti-vaccine zealots had some role in the victory of “vaccine choice” supporter Chris Christie over Jon Corzine for governor of New Jersey, although, having recently lived in New Jersey, I’d say that it was far more Corzine’s incompetence than his stand on vaccines that led to his defeat earlier this month.

Other political and legal initiatives of the anti-vaccine movement have been much less successful. For example, for all the momentary attention it brought the movement, Jenny McCarthy’s and Jim Carrey’s “Green Our Vaccines” rally in Washington, DC last year resulted in no real concrete gains for the anti-vaccine agenda, try as various anti-vaccine activists might to point to use it for “momentum.” Later last year, after the election of Barack Obama, the efforts of Robert F. Kennedy, Jr. (whose masterpiece of cherry picking, Deadly Immunity, had stoked the flames of the anti-vaccine movement back in the summer of 2005) failed to persuade President Obama to give him a cabinet post in his administration. More recently, the Autism Omnibus, a huge class action legal appeal to the Vaccine Court, flamed out spectacularly, as the best “science” the movement could put forward was not enough to convince a special court that is plaintiff-friendly by design that “vaccine injury” can cause autism. Worse, this ruling came down in close temporal proximity to the revelation that a hero of the anti-vaccine movement, Andrew Wakefield, upon whom Age of Autism had bestowed its 2008 Galileo Award, had almost certainly–shall we say?–applied a bit too vigorous a “massage” to the “data” (if you can call it that) that he had used in his now infamous 1998 Lancet article allegedly linking the MMR vaccine to “autistic enterocolitis.”

Now, failing to convince using science, Generation Rescue, through its propaganda blog Age of Autism, is announcing a new initiative whose explicit intent is to try to enact an anti-vaccine agenda into law. This time, though, GR is much more clever about it than it may have been in the past. Gone are all those nasty and “inconvenient” signs among marchers at the “Green Our Vaccine” rally equating vaccines to toxic waste or even “weapons of mass destruction” and proclaiming that vaccines had “poisoned our son.” In its place are appeals to “informed consent” (the same ploy that the granddaddy of anti-vaccine groups, the NVIC, has used), for more “testing” of vaccines, and–of course–for the “vaxed versus unvaxed” study. GR’s plans are, in fact, laid out in detail for anyone to read in three posts by Kent Heckenlively:

• The “Green Our Vaccines” Initiative for Autism
• The “Green Vaccines” Initiative
• A Quick Guide to the “Green Vaccines” Initiative

Here is how Heckenlively describes the reason for this initiative:

I’d hoped the Special Masters of the Vaccine Court would put an end to the vaccine/autism catastrophe.  Nobody was more surprised than me by the decisions earlier this year in the cases of Cedillo, Hazlehurst, and Snyder.   
As an attorney I have great respect for the judicial system but the decisions struck me as terribly flawed.  Maybe I shouldn’t have been surprised.  The Vaccine Court isn’t really part of the traditional legal system.  It was a creation of the pharmaceutical companies to shield themselves from liability.  Why else would a plaintiff be unable to force a defendant to produce a single document or witness without the permission of the Special Master? These companies and the U. S. government know they have something to hide.

He’s even more explicit in the latest post:

We’re not going to get anywhere with our current legal system because everything gets funneled into Vaccine Court.  We’re not going to get far with the current media because they’re so heavily funded by pharmaceutical drug ads.  We’re not going to get far with the medical community because they’re part of the machinery.

And don’t even get me started on the politicians.  On one hand you have pharma handing out millions of dollars to politicians, and on the other you have parents of children with autism who are slowly bankrupted by this disease.  Who do you think is going to have more money to “support” the politician of their choice?

So what is this “initiative”? It’s an attempt to build a grassroots movement to persuade legislatures to pass legislation that ties in to the anti-vaccine agenda of Generation Rescue and similar groups. The proposals that this movement seeks to promote fall into five categories that GR wants to hire political consultants to “poll test” while at the same time wording them so that the pseudoscientific anti-vaccine agenda behind them is not obvious:

1. Research/Testing – Oregon requests the federal government to return the records of the Vaccine Safety Data-Link from private industry and make them available to independent researchers, conduct a study of vaccinated and unvaccinated children, study the health effects of aluminum adjuvants, and other substances used in vaccines like hydrolyzed gelatin and sorbitol.
2. Disclosure/Informed Consent – Comparison of Oregon schedules with that of the CDC and other first world countries and full disclosure of vaccine ingredients, as well as the level of safety testing on them.
3. Banning – Thimerosal ban across the board, as well as the flu shot for pregnant women, multiple vaccinations at a single visit, a six month ban on vaccines for premature births, and three months for any infant.
4. Changes to Existing Law – Adding a philosophical exemption for Oregon, reducing required vaccines, restriction of the Vaccine Act of 1986 to unavoidably unsafe components of vaccines, and additional rights of military personnel to choose alternative vaccination schedules.
5. Consumer/Parental Choice – Giving parents the freedom to choose aluminum and formaldehyde free vaccines, a different vaccination schedule, a titer check before vaccination, as well as one for mitochondrial disorders which might be exacerbated by a vaccine, and the right to have multiple vaccines such as MMR split up into individual doses.

How did Oregon get so lucky to be the “test state” for this initiative? Well, that’s where J.B. Handley lives. Sorry, Dr. Crislip.

That aside, it all sounds reasonable on the surface, doesn’t it? It’s particularly true if you don’t know the science behind vaccines, the anti-vaccine canards behind each of these five areas, and what these initiatives really mean. For example, it sounds so reasonable to open VSD data to “independent” researchers, doesn’t it? In fact, what GR really wants is for their pseudoscientists to be able to pick over the data and try to find spurious correlations. In fact, that’s just what happened when Mark and David Geier gained access to the VSD database in 2003, as Kathleen Seidel recounts. They went beyond what their IRB-approved research protocol allowed, tried to remove data, and as a result Kaiser Permanente’s IRB Administrator received a warning letter from the CDC about the Geiers’ attempts to merge datasets in a way that could compromise patient confidentiality. In reality, what GR wants is the opportunity for more anti-vaccine “researchers” to abuse the VSD as they have abused the VAERS database in order to produce dubious studies that claim to show a link between vaccines and autism. As for the call for a “vaccinated versus unvaccinated” study, I discussed that issue in detail a while back, and it’s worth reading again to see what the real agenda is behind calls for such a study, as well as to understand why such a study is not only impractical but superfluous.

The issue of disclosure and informed consent is also deceptive in that risks of vaccination are already disclosed and parents already have to give informed consent. The purpose of this item is to be able to play the “toxin” gambit by listing all sorts of scary-sounding ingredients in vaccines whose identity is already listed on the CDC website and to play up theoretical “risks” of autism that have not been scientifically validated, particularly the claim that the U.S. is “overvaccinated.”

The third item is particularly despicable, in my opinion. For one thing, the idea that thimerosal causes autism is a scientifically discredited hypothesis. For another thing, most childhood vaccines are already thimerosal-free, other than trace amounts, the exception being the flu vaccine. Finally, it’s the height of irresponsibility to call for banning the flu shot for pregnant women during the H1N1 pandemic. After all, they are one of the groups who are at increased risk for complications and can thus use the protection. Even worse is the call for a six month ban on vaccinating premature babies; premature babies arguably need protection even more than babies born after the normal period of gestation. There is no valid scientific justification for any of these proposals; more than anything else, they are born of the anti-vaccine movement’s fear and loathing of vaccines, and the proposal to ban multiple vaccines at a single visit is clearly custom-made to reduce the number of babies receiving all the currently recommended vaccines.

The last two proposals, I will admit, are clever. As I pointed out before, it’s far more attractive to frame one’s argument as being for something like “parental choice” than against something like life-saving vaccines. However, what these two proposals represent is an attempt by the anti-vaccine movement to legislate the standard of care to its wishes. Aluminum is safe and effective, with over an 80 year history of safe use, while removing formaldehyde from vaccines is totally unnecessary given that it’s a chemical that our own bodies make in quantities far greater than is in any vaccine. I once pointed out to Dr. Jay Gordon that he and his children are probably exposed to far more formaldehyde from auto exhaust when he sits in Los Angeles traffic than any vaccine contains. Moreover, formaldehyde is used for a specific purpose, namely to inactivate the virus being used for the vaccine. If formaldehyde weren’t used for that purpose, some other chemical, perhaps one not nearly as well-studied, would have to be used. Basically, what these last two proposals would do is to allow anti-vaccine activists to dictate the standard of care to physicians and to use basically any ingredient that they don’t like in vaccines as an excuse to refuse vaccines. It would also allow them to force doctors to order tests that aren’t routinely indicated, such as measuring antibody titers, or that are only very rarely indicated, such as tests for mitochondrial disorders because they mistakenly think mitochondrial diseases render children more likely to become autistic after vaccination. Apparently, such parents don’t mind subjecting their children to muscle biopsies for no good reason, because that’s what it sometimes takes to nail down a diagnosis of mitochondrial disorder. At the very least it takes a battery of other tests. It’s not a trivial matter and, because mitochondrial diseases are so uncommon, routine screening is far more likely to cause false positives than it is to be reliable.

Like naturopaths seeking prescribing privileges, the anti-vaccine movement has lost on the science. It can’t support its claims that vaccines cause autism or other neurolodevelopmental disorders, and it can’t validate the various “biomed” treatments that it promotes to “reverse vaccine injury” any more than naturopaths can show that their methods work reliably or that they have sufficient knowledge to be able to prescribe drugs safely. It’s all of a piece with many forms of pseudoscience, such as how it took a powerful Senator to ram NCCAM down the throats of NIH scientists, not based on any scientific merit or clamoring by the medical community for such a center but rather based on the raw political power of a woo-friendly politician.

Pseudoscientific movements are persistent and patient, too. If the naturopaths and Generation Rescue don’t get their wishes this time, they’ll be back again and again and again. Count on it. I liken them to casino interests in my city. Casino operators first started trying to get casinos into the city of Detroit at least three decades ago. Every time a measure was put on the ballot to allow them it was voted down. Casino owners just kept trying again and again and again, until several years ago they got what they wanted, probably thanks to the opening of casinos across the river in Windsor. A similar story played out in Ohio, where casino interests tried four times and failed four times to get the voters to allow casino gambling in Ohio before finally getting the votes they needed earlier this month. The analogy to casino gambling is an apt one, too. If states allow pseudoscience like that anti-vaccine movement or naturopaths to dictate medical policy and the standard of care, we will be indeed gambling with public health in a way as risky to medicine and health policy as walking into the MotorCity Casino is to $500 in a gambler’s pocket. The difference, of course, is that in the case of letting people like J.B. Handley there’s virtually no chance that we could win big–not even the same chance a one-armed bandit provides.

Two weeks ago, Canadian Skeptics United published on their Skeptic North site a piece by an Ontario pharmacist criticizing a proposal by the province to grant limited prescribing rights to naturopaths. The essay, which was reprinted in the National Post on Tuesday, outlines the intellectual and practical conundrum presented by allowing those with education that diverges from science-based practices to prescribe drugs.

The naturopath lobby came out in force and was relatively unopposed in the 54 comments that followed, primarily because the NP closes comments 24 hours after online posting. Therefore, those with a more rational and considered viewpoint based in facts were locked out from commenting. This is quite disappointing to me personally and professionally because of the wildly emotional appeals, strawman arguments, and smears and attacks on the author himself without, of course, addressing his well-founded criticism of the prescribing proposal before the provincial government.

At the Skeptic North post, the piece even drew a naturopath who equated the criticism of his/her field with the Nazis and Mussolini. However, you can’t write critiques of these practices without attracting attacks ad hominem, especially Godwin’s Law, that are the resort of those whose arguments are logically flawed.

Naturopathy, sometimes called naturopathic medicine, is an unusual and inconsistently regulated alternative medical practice that co-opts some evidence-based medicine, often in nutrition and natural product medicines, but also subscribes to “vitalism” (vis medicatrix naturae) and makes use of homeopathic remedies that defy the rules of physics and dose-response pharmacology.

Naturopathy is, however, a warm and fuzzy term, especially when equated with “natural medicine” and the fact that people with naturopathy degrees advertise themselves with the honorific of “Dr.” The increasing popularity of naturopathy is also supported by cultural influences. I’ve written elsewhere that many, uh, natural product enthusiasts have become interested in naturopathy following the relocation of musician Dave Matthews from Charlottesville, VA, to Seattle, WA, where his wife, Ashley Harper, earned a naturopathy degree at Bastyr University.

In addition to the description of the practice in the NP op-ed, an excellent review and critical analysis of naturopathy by SBM’s Kimball C Atwood IV, MD, can be found at Medscape General Medicine. The abstract is as follows:

“Naturopathic medicine” is a recent manifestation of the field of naturopathy, a 19th-century health movement espousing “the healing power of nature.” “Naturopathic physicians” now claim to be primary care physicians proficient in the practice of both “conventional” and “natural” medicine. Their training, however, amounts to a small fraction of that of medical doctors who practice primary care. An examination of their literature, moreover, reveals that it is replete with pseudoscientific, ineffective, unethical, and potentially dangerous practices. Despite this, naturopaths have achieved legal and political recognition, including licensure in 13 states and appointments to the US Medicare Coverage Advisory Committee. This dichotomy can be explained in part by erroneous representations of naturopathy offered by academic medical centers and popular medical Web sites.

Like many alternative practices, naturopathy claims to harness the body’s own healing power as if differentiating that fact-based medicine does not also employ the body’s capacity to heal. The very same drugs that naturopaths wish to prescribe are those which can only work because they interact with targets in the body for which our endogenous compounds already act.

It seems to me that naturopathy adopts either science-based medicine or pseudoscience depending on the venue in which it serves the organization.

Because of my oft-expressed love of Canada, I had always thought that our neighbors to the north were more rational and had more finely-tuned critical thinking skills than we in the United States. However, I learned from the op-ed that British Columbia has already given prescribing rights to naturopaths.

I’m really surprised about this because of the furor that erupts whenever a proposal comes up to confer limited prescribing rights to pharmacists. Having taught in US colleges of medicine and pharmacy, I can state confidently that pharmacists have roughly four times the pharmacology and therapeutics coursework of physicians (albeit with not nearly as intensive postgraduate training). With the Doctor of Pharmacy degree firmly established as the entry-level pharmacy degree, pharmacists are now participating with physicians to gain practical clinical training in specialty areas.

But even with this extensive training in the same environment, legislated pharmacist prescribing is extremely limited worldwide. I remember it being a monumental achievement when my former PharmD student became the first pharmacist in the state of Arizona to have earned limited prescribing rights.

Therefore, I am amazed that Canadian politicians and health authorities are lending support to naturopath drug prescribing.

Another major challenge of this proposal relates to medical liability, an issue that seems to have been ignored previously but is articulated nicely in the NP op-ed:

A key role of the pharmacist is to double-check the safety and appropriateness of a prescribed drug. When required, the pharmacist resolves drug related problems with the prescriber. This is only possible because pharmacists, physicians, and nurse practitioners work from a common, science-based understanding of drugs and disease. In contrast, naturopaths may not share this science-based approach to illness, and may rely on references that are unknown to, inconsistent with, or directly contradict the medically accepted standard of care. If naturopaths prescribe a drug based on a naturopathic belief system, and a pharmacist determines that the prescription is not appropriate from a scientific and evidence-based perspective, what will the pharmacist’s responsibility be? Will pharmacists be held liable for prescriptions written by naturopaths who do not share a science-based view of illness?

Here’s a question, though: if the legislation moves forward, could pharmacists refuse to fill a prescription from a naturopath the same way that some states allow for “conscientious objection” by pharmacists for filling emergency contraceptive prescriptions?

I also wonder why pharmaceutical companies have not gotten involved in this debate. Corporate liability is also likely to be influenced as improper prescription of drugs is bound to increase the number of reported adverse reactions.

Nevertheless, the bill is moving forward:

The Bill passed second reading and was referred to the Standing Committee on Social Policy. Several naturopath organizations were on the agenda, and argued for “unambiguous authority for prescribing, compounding, dispensing or selling a drug as designated in the regulations” – essentially a clause that will allow naturopaths gain access to prescription drugs, developing a list out of the public eye. The standing committee accepted this request (the revisions may be viewed here [PDF]), and put naturopath prescribing into Bill 179. Third reading is expected sometime this fall. If it passes, the right for naturopaths to prescribe drugs will become entrenched in Ontario law.

The legislation of quackery presents a major threat to public health, pure and simple.

A rebuttal from two naturopaths has now appeared at the National Post. Therein, the typical distancing from science-based medicine is claimed while concomitantly arguing that naturopathy is based in science, followed then by excoriation of the randomized, controlled clinical trial. The typical chesnuts of distinction are invoked such as recognizing the healing power of the body, individualized patient care, and focus on disease prevention – all of which science-based medicine employs no matter how it is spun. One cannot simultaneously claim to embrace and reject science, yet this is done in the NP rebuttal. The responses are much more reasoned including an especially superb point-by-point comment by “steveisgood” (the page doesn’t provide unique URLs for each comment so you’ll have to scroll down by hand).

I am just a parent with some questions about vaccine safety and was happy to find your website.  I have noticed that the Scandinavian countries do not routinely recommend HepB vaccination unless the mother is a known carrier.  I did not see this addressed anywhere on your website and I hope you or one of your colleagues might consider discussing the reasons that some advanced countries are not routinely giving this particular vaccine. Thank you.”

Vaccination is a complicated and at times confusing topic that generates a large number of quite reasonable questions by parents like the one above.  At the same time, the ever-wandering aim of the anti-vaccinationist movement appears once again to be falling on the vaccine against Hepatitis B, and I’ve heard them pose this very question with the intent of sowing doubt in the current vaccination schedule.  Regardless of the source, this question is clearly on the mind of some parents, and I am happy to answer it.

As usual, this question has quite a bit to parse out.  I think it may be most helpful to examine why we vaccinate against Hepatitis B the way we do in the US, how most countries in the world approach the problem, and finally examine the reason why eight European countries do not universally vaccinate against HBV.  First things first though: what is Hepatitis B?

HEPATITIS B

Hepatitis B (HBV) is a double stranded DNA virus found in the bodily fluids of infected people including their blood, semen, and saliva, and can be transmitted through sexual contact, exposure of infected fluid to mucous membranes, or through injection.

As the name suggests, infection causes damage primarily to the liver, though the spectrum of disease experienced by any one person can be quite broad.  In adults, 50-70% of infections are asymptomatic or mild enough to not come to medical attention.  The remaining adults experience a range of hepatitis lasting weeks to months, with ~1% of these being a fulminant, life-threatening infection.  Adults are relatively efficient in their ability to clear the virus after the initial infection, and only ~10% become chronicly infected carriers.

Children, on the other hand, present a very different pattern of disease.  Though ~90% of infected children are initially asymptomatic, they are rarely able to clear the virus.  90% of infants and 25-50% of those 1-5 years old will become lifelong carriers.

Chronic Hepatitis B infection is a serious problem.  Beyond the ability of most chronic carriers to spread the virus throughout their lives, ~ 20% of people with chronic Hepatitis B develop cirrhosis, a condition where the liver cells are lost and the liver becomes progressively more fibrotic and dysfunctional.

Cirrhosis isn’t the only life-limiting problem to result directly from chronic Hepatitis B infection.  Hepatocellular carcinoma, a primary cancer of the liver, is in the top 10 cancers in both sexes in the US, and 60-80% of all cases are cause by Hepatitis B.  All told, around 25 % of people who become chronically infected with Hepatitis B will die from its complications.

Hepatitis B is a major cause of worldwide morbidity and mortality. More than 1/3 of the world’s population has been infected with Hepatitis B and 5% are chronic carriers.  That totals up to around 350,000,000 people chronically infected, and around 620,000 deaths from HBV yearly.

As in many health care related issues, the worldwide epidemiology of HBV infection does not necessarily reflect that of the United States.  Even so, the picture isn’t particularly pretty.  Around 5% of the US population has been infected with Hepatitis B, and 0.3 are chronic carriers.  Most HBV infections occur in those aged 25-44 (4/100,000), with the lowest rates of infection in those under 15 (0.1/100,000).   In 2007 4,519 new cases in the US were reported to the CDC, though this represents a fraction of the total number of infections.

These numbers are significant.  To put this in perspective, the mortality from HBV in the US was 5 times higher than Haemophilus influenza type B and 10 times greater than measles before vaccination was introduced.

The Hepatitis B Vaccine

HBV is a relatively stable virus posing a serious public health threat with humans as the only known reservoir, and as such is a prime target for prevention, and theoretically eradication, through vaccination. The first vaccine against HBV became available in 1981, and the current recombinant vaccine has been in use since 1986.  As a recombinant vaccine it contains proteins normally made by HBV, but does not have the virus itself, and therefore carries no risk of HBV infection.

As far as efficacy is concerned, the HBV vaccine has a very high response rate, inducing an appropriate antibody response in more than 95% of people from birth to 30 years of age, and decreasing but still significant response rates in older age groups.  Immunity from the vaccine lasts at least 20 years in healthy individuals.

The HBV vaccine has an excellent safety record.  The most common side effects are pain and swelling at the injection site in ~3% of people, and fever in ~1%.  The only serious confirmed reaction is anaphylaxis that occurs in 1/600,000 injections with no deaths reported in over 20 years of use.  Concerns regarding the HBV vaccine’s association with demyelinating diseases, the use of thimerosal in its formulation in the past or aluminum at the present have all been investigated and found to be without support; I will give such allegations no further time in this post.

Strategies of Hepatitis B Vaccine Use

There are a number of viable strategies available to countries seeking to address the spread of HBV in their populations, and variants on each.  When deciding which strategy is best for any given country, there are multiple factors to consider, including disease severity, the availability and efficacy of treatments, the risk and cost of infection, the risk, efficacy and cost of vaccination, etc.

The first option is to vaccinate people at high risk of infection.  In situations where the risk of infection is very low this makes good sense.  For instance, in the US the risk of contracting Yellow Fever is essentially zero at baseline without vaccination.  No risk or cost of vaccination, no matter how small, is small enough to offset zero risk of disease, therefore we do not routinely vaccinate against it.  However, if you were to travel to an area where Yellow Fever is endemic, your personal risk can suddenly become significant, and easily justify the minimal cost and risk of vaccinating you as a person at high risk.

Since the majority of people infected with HBV have identifiable risk factors, this approach makes some sense.  However, it has several major drawbacks.  It requires all individuals in a high-risk group to have health care, be identified, and to acquire the vaccine before they are infected.  This is labor and cost intensive, and extremely unlikely to capture the entire target population. Well executed, this approach can protect a majority of people at high risk, but in the case of HBV it will not immunize a large enough population to generate a herd immunity effect. The greatest flaw of this approach lies in the 1/3 of HBV infections that occur in people with zero known risk factors who, by definition, are unable to further reduce their risk, and are left unprotected by a vaccine. These shortcomings guarantee this strategy will fail to fully control the spread of HBV in the community.

The second approach is to vaccinate the entire population as they enter into the age of greatest incidence of infection, adolescence and early adulthood.  This addresses one of the shortcomings of the first strategy, namely the need to identify people at high risk.  It also takes advantage of the fact that children more reliably have health-maintenance office visits than do adults, and are more likely to be given vaccinations as part of a universal schedule.

Though this captures a large majority of the total number of infections, it too has a flaw; it fails to address the people infected in early childhood.  Though this is a relatively small number of people (4% of HBV infections), remember that children are far more likely to become lifelong carriers, and thus make up a disproportionate number of the infected at any one point in time (24% of chronic carriers).  While more effective at reducing the prevalence of HBV in the population than only vaccinating high-risk groups, this strategy too has little hope of eliminating HBV.

The third possible strategy is to vaccinate people at the time of birth.  This strategy addresses the problem of perinatal infection, prevents the acquisition of HBV by people during early childhood when the risk of chronic infection is highest, and since the immunity it induces lasts for decades it covers the entire population during the highest risk times of their lives.  Universal vaccination with HepB vaccine at birth, even in regions with a low prevalence of chronic carriers like the US, could reduce mortality by an additional 10-20% compared to early childhood vaccination.

Even this strategy has a drawback, however, and that is time.  Beginning an immunization program with only infants would take a few decades to generate a maximum reduction in HBV in the population.

The US Vaccination Strategy

Though the burden of disease from HBV in the US is relatively low compared to say, heart disease, it remains a significant public health threat only partially addressed through screening, education, and preventative measures, and with limited treatment options.  This makes it an ideal target for vaccination.

From 1981 through 1991 the US vaccinated only people with identified risk factors. Predictably, this campaign had an underwhelming effect on HBV infections seen during this time period.

In 1991, the strategy was reworked to better address the various methods of HBV transmission in an attempt to eliminate HBV spread in the US.  The new strategy is an amalgam of all three strategies described earlier. In addition to vaccination of high risk groups, we began universal vaccination of all infants at birth, vaccination of adolescents, and prenatal screening of pregnant women to identify children who would require not only vaccination at birth but also Hep B immunoglobulin (HBIG).

Since its launch in 1991, we have seen a steady decrease in Hepatitis B infections. Hep B incidence in the US fell from 10.7/100,000 in 1983 to 2.1 per 100,000 in 2004. (25,916 total cases down to 6212 cases).  Though it’s true other factors have been contributing to HBV’s decline, most notably the public education campaign aimed at curbing the spread of HIV, this doesn’t account for the pattern of HBV decline across age groups.  There has been a 95% drop in HBV in people under 15 years of age, 87% in ages 15-24, 71% from 25-44, and 51% decrease in people over 45 years old.  This is precisely what you would expect from a pediatric vaccination campaign.

Using a cost effective and exceptionally low-risk intervention of universal Hep B vaccination the US is well on its way to control, if not elimination, of HBV.

The Northern European Vaccination Strategy

The strategy taken by the US is typical of most developed nations, even those with a relatively low incidence of HBV.  In 1992 the WHO recommended the inclusion of HBV vaccination in nearly all national vaccination programs.  Since that time, the vast majority of countries (177/193 countries) have adopted infant HBV vaccination into their childhood schedules as can be seen here.  This graphic also illustrates the few countries that have instead opted to vaccinate only high-risk individuals, primarily those in Northern Europe, including Scandinavia.

The reason these countries have not adopted universal vaccination against HBV is the exceptionally low level of HBV in their population and the associated costs of prevention.  Sweden, for instance, has one of the lowest prevalences of HBV in the world at 0.05%.  This is 6 times lower than what we have in the US, with the majority of cases occurring in those engaged in high-risk activities or in immigrant populations that tend to have minimal contact with the indigenous population.  The public health organizations of these Northern European countries consider HBV to be a minor public health problem best addressed by targeted vaccination.  The cost of instituting universal vaccination would not offset the benefit of further reduction in HBV prevalence in their countries.

It is interesting to note that though these countries have low baseline rates of HBV infection, they have not generated the same relative decrease in rates that countries, like the US, have been able to produce with universal HBV vaccination.  This fact, in combination with high immigration rates to these countries from areas of heavy HBV, makes it likely that the cost/benefit ratios of the Northern European countries will sway even more strongly in favor of universal HBV vaccination over the next several years.

It is also worth noting that of the many factors being weighed by the medical community and public health officials of these Northern European nations, serious concerns of the Hepatitis B vaccine’s efficacy or safety are not among them.

Conclusion

We will continue to make progress in medicine by never being satisfied the care we provide is good enough; the ongoing debate about how best to apply the Hepatitis B vaccine is an excellent example of this concept.  The inconsistency between these nations’ vaccination policies is little more than physicians and health care officials seeking the most efficient and effective use of the vaccine within the unique conditions inside their borders.

I don’t know. The mainstream media is doing a wonderful job sensationalizing this case, presenting it without skepticism. Some outlets are doing a good job of discussing the relevant issues – but they don’t have the information to have a meaningful discussion of this particular case. Details are tantalizing but thin.

The case is that of Rom Houben. The story was broke, as far as I can tell, by the Mail Online – yes, that is a huge red flag. It does not make the story wrong, it just doesn’t instill in me confidence in the reporting.

Mr. Houben was in a terrible motor vehicle accident 23 years ago and has been paralyzed ever since. His diagnosis has been PVS – persistent vegetative state. However, recently, we are told, his mother insisted on a neurological re-evaluation. This is actually quite reasonable, generally speaking (again, without knowing specific details of this case).

As a result Dr. Steven Laureys did some advanced neuro-imaging on Mr. Houben. Laureys is a neurologist with not only legitimate but impressive expertise in coma and disorders of consciousness. Often the press throws around the term “top expert” without any meaning, but in this case the term seems appropriate.

I do not know what imaging was done, but Dr. Laureys’ team is doing research using functional MRI scanning and MRI spectroscopy – techniques which infer brain function from blood flow or metabolism. They are using these scanning techniques, during resting and activated states, to see how much cortical brain function there is in patients in apparent coma.

According to the press reports, Dr. Laureys found that Houben’s brain function was intact, or almost intact. This led to further evaluation of Mr. Houben’s clinical state, and it was discovered that he was able to communicate by typing out messaging on a board. Mr. Houben soon began recounting how he was awake the whole time, screaming inside his head, and eventually retreated into his dreams. He now feels like he has been reborn and looks forward to interacting with his family.

This is a wonderful story for the media. But to this neurologist, and I would think to any critically-thinking journalist, some questions come to mind. The biggest problem with this case as presented is that the finger-typing of Mr. Houben looks suspiciously like facilitated communication.

But first, a little background.

Coma, PVS, Minimally Conscious State, and Locked In Syndrome.

I have written previously about the various types of coma or disorders of consciousness. There are three states that are worth defining to understand this and similar cases. The first is persistent vegetative state (PVS) in which there is insufficient brain activity to general consious awareness. People in a PVS may display signs of wakefullness, like moving their eye and opening their mouths, but do not interact with their environment.

It is important to note that many people in PVS have documented brain damage of such an extent that there really is no question about the diagnosis, or their prognosis.

But, of course, there is also a gray zone, or transition from PVS to minimally conscious state (MCS). In an MCS a person cannot communicate but they do display signs that they can respond to their environment. Prognosis is very poor, like in PVS, but one notch above hopeless, with rare cases of meaningful recovery.

I must point out at this point also that I am talking about chronic states – not people who are days or weeks after an injury or event. People can recover after a significant injury, but they typically show potential for recovery early on. After months or years in a coma, the prognosis is grim.

In terms of diagnosis, it can be challenging to distinguish between PVS and MCS – it’s the different between no signs of consciousness and minimal signs of consciousness. Of course, there may be very subtle signs that are missed. And as our technology improves, we are sure to have greater sensitivity and pick up more cases of MCS misdiagnosed as PVS.

It remains to be seen, however, if the subtle distinction is clinically meaningful.

To add to the complexity, however, there is a condition call locked in syndrome. In this (thankfully rare) syndrome patients are conscious but paralyzed. For example, a brainstem stroke might cause a person to be paralyzed below the eyes – all they can do is blink and move their eyes. But they are fully conscious if the thinking part of the brain is intact.

Facilitated Communication

Facilitated communication, or FC, has nothing to do with coma but is relevant to this case because of some of the media reports. FC is the technique of holding a patient’s hand to “help” them communicate by pointing to letters on a board.

When FC was first proposed to the therapy community, it seemed like a powerful new technique – countless children who were thought to be too brain damaged to communicate were believed, due to FC, to actually have almost intact intellects trapped inside a non-communicating body.

Unfortunately, FC was promoted prior to proper scientific validation. When it was studied in properlyh controlled blinded trials it turned out the the facilitator, and not the client, was doing all the communicating. FC is nothing but a well-meaning delusion. But it is also a dangerous one – FC testimony has led to the false conviction of adults accused of abuse.

While we do not want to miss any cases of a person’s hidden ability to communicate, the FC experience teaches us to be cautious. We must always ask – is communication (or any sign of consciousness) real? Has it been validated in an objective and controlled way?

The Houben Case

I am always a bit uneasy analyzing these media cases, because I often do not have direct access to the patient or the medical records. So I have to add the standard disclaimer – my analysis is based upon the information that has been made public, not a thorough medical evaluation of the patient. I can often only analyze the pieces of evidence I am given, and speculate as to probabilities.

In this case there are several interesting aspects that do not all fit together. The first question is whether or not it is plausible that a patient would be diagnosed as being PVS when in fact they were locked in (that is the claim in this case). That would be unusual, but not impossible.

Typically when patients are locked in there is identifiable damage that can produce widespread paralysis, but the cortex should be relatively spared. In addition, there are typically some residual functions remaining, like eye movements. But it is possible for even that to be lacking.

More likely is the possibility that Mr. Houben was initially comatose but then over the years his brain function improved until he was able to be conscious. But by that time he was paralyzed and debilitated, and so not able to move to demonstrate his consciousness – locked in. Also by that time he would likely be in a chronic care facility and may not have had close neurological exams.

So while this would be an usual case, I can buy it. Further, this is consistent with the finding of preserved cortical activity on functional scanning.

The implications of this case, and similar cases, is that we need to use careful and standardized neurological exams to assess comatose patients, and they should be periodically reevaluated. But at the same time – not all cases have the potential to improve. Some patients are injured beyond the plausibility of making meaningful recover, and families should be given a realistic assessment of their loved-one’s condition. Also  – cases like this are the rare exception, not the rule.

Now comes the tricky part – the clinical correlation. Looking at brain anatomy and activity is important, but must be placed into a proper clinical context. At present, the clinical exam is still critical.

I don’t know what Mr. Houben’s exam is. But I do have a video of him communicating. What I can say with high confidence is that this is a video of bogus facilitated communication. The “facilitator” appears to not just be supporting Houben’s hand, but moving it around the keyboard.

Houben is looking in the general direction of the keyboard, but at times not directly at it (which is necessary for single finger typing). It is not clear if he can even see, and since his eyes are not in line it is not clear which eye he would be using.

His hand is also in a brace; his finger is not touching the board – the plastic of the brace is – so he would have little sensory feedback.

And yet his hand flies dextrously across the board typing very quickly. It seems impossible that someone with his level of paralysis, and years of inactivity, would be able to type so quickly with just a little “support”. There is little doubt, in other words, that his typing is the product of bogus FC – the facilitator is doing the communicating, not Houben.

Reporting of his typing is without skepticism, and so basic questions are not addressed. It would also be almost trivial to test whether or not the communication were legitimate – the report says he responds in Flemish – so have a non-Flemish speaking facilitator hold his hand. Apparently, he also understands English so you could have a non-English speaking facilitator answer questions posed in English. Or blind the facilitator to the keyboard or visual information that Houben has access to.

What would not be sufficient, however, is a knowledge test – asking Houben about events in the past or about his life, for example. This is too difficult to tightly control – a facilitator may have been contaminated, or may just make obvious or lucky guesses.

In an interview for NPR, Laureys reports that the family came up with the method of communication, and it was validated by having Houben identify objects that were show to him – that’s it. Laureys also reports that the medical doctors were skeptical of this communication, and it seems right that they were.

Until a tightly controlled test is done, the FC evidence is worthless.

But I do not know if this is the only clinical evidence of consciousness in Houben. Perhaps he can do what other locked in patients can do – tap once for “yes” and twice for” no,” for example. Maybe the FC is a later addition – a misguided attempt to communicate with Houben, who really is locked in. (In which case I wonder what he thinks about his facilitator – perhaps he is still screaming in his head, “get rid of this nut and let’s go back to the finger tapping.”)

The only thing I am certain about in this case is that the typing out of messages through FC is bogus. Otherwise, I do not have access to sufficiently detailed information to make any specific conclusions.

Hopefully, more information will come to light as further journalists are attracted to this case. Also, I have e-mailed Dr. Laureys hoping to get some more information directly from him. He responded with a link to his paper on this topic, but there is no identifiable information in the paper about Houben. He simply says that Houben illustrates the problem discussed in his paper – the misdiagnosis of MCS as PVS. He did not comment on the FC used in this case. If I get any further information I will write a follow up.

Meanwhile, this case stands as a cautionary tale – mostly about the dangers of the media discussing the implications of a story before the facts have been verified. It may also be a rare case of misdiagnosed locked in syndrome. My best guess is that Dr. Laureys is correct about the preserved cortical activity, but he is simply not familiar with the phenomenon of FC (he did not sound familiar on the interview) and has been deceived by it.  If this is so, then the FC is an unfortunate distraction from this case (and getting disproportionate attention from the media). I am already reading science bloggers comment on the fact that the video of Houben typing calls the whole case into question.

It is also, in my opinion, a further abuse of this patient. Mr. Houben, if he is truly conscious, has now been deprived once again of his ability to communicate – usurped by a facilitator, who will be communicating in his name (and even writing a book, we are told). Never underestimate the ability for pseudoscience to make a bad situation worse.

Addendum: Here is a new video in which Houben clearly has his eyes closed while the “facilitator” is typing furiously. This is completely impossible. (Hat tip to Orac for the link – he has also discussed the case.)

It is a potentially devastating indictment of the rising C-section rate. Most midwifery and “natural” childbirth websites claim that elective C-section triples the rate of neonatal mortality. Mainstream web sites like Feministing.com, and newspapers like The New York Times have repeated the claim. There’s just one problem. It’s not true.

The claim originated with the paper Infant and Neonatal Mortality for Primary Cesarean and Vaginal Births to Women with “No Indicated Risk,” United States, 1998–2001 Birth Cohorts, MacDorman et al, Birth Volume 33 Page 175, September 2006. According to the authors:

Neonatal mortality rates were higher among infants delivered by cesarean section (1.77 per 1,000 live births) than for those delivered vaginally (0.62). The magnitude of this difference was reduced only moderately on statistical adjustment for demographic and medical factors, and when deaths due to congenital malformations and events with Apgar scores less than 4 were excluded. The cesarean/vaginal mortality differential was widespread, and not confined to a few causes of death. Conclusions: Understanding the causes of these differentials is important, given the rapid growth in the number of primary cesareans without a reported medical indication.

The implication, of course, is C-sections done without a medical indication raises the risk of neonatal death by a factor of three. The entire study hinges on a critical detail. Are women with “no indicated risk” really women who have no risk factors? The answer is a resounding no.

Since birth certificates are such an important source for research information, they have been repeatedly studied for accuracy. Birth certificates are highly accurate for administrative data like parents’ names or numerical data like weight or Apgar scores. It is well known, however, that they are highly inaccurate when it comes to listing complications.

How Well Do Birth Certificates Describe the Pregnancies They Report? The Washington State Experience with Low-Risk Pregnancies, Dobie et al report:

Conclusions: Because birth certificates significantly underestimated the complications of pregnancies, number of interventions, number of procedures, and prenatal visits, use of these data for health policy development or resource allocation should be tempered with caution.

The reporting of pre-existing maternal medical conditions and complications of pregnancy on birth certificates and in hospital discharge data,  M. Lydon-Rochelle,  et al. found:

Results Birth certificate and hospital discharge data combined had substantially higher true-positive fractions than did birth certificate data alone for cardiac disease (54% vs 29%), acute or chronic lung disease (24% vs 10%), gestational diabetes mellitus (93% vs 64%), established diabetes mellitus (97% vs 52%), active genital herpes (77% vs 38%), chronic hypertension (70% vs 47%), pregnancy-induced hypertension (74% vs 49%), renal disease (13% vs 2%), and placenta previa (70% vs 33%)… Conclusion In Washington, most medical conditions and complications of pregnancy that affect mothers are substantially underreported on birth certificates,…

In other words, for virtually every serious pregnancy complication, that information was missing from the birth certificate in more than half the cases.

Even a cursory look at the data showed that the authors assumptions were entirely unfounded. Women in the group characterized as planned C-sections for “no medical indication” had birth certificates that indicated that they had been in labor for hours before the C-section. Although the indications had been absent, it was clear that there must have been indications for the C-section.

In response to pointed criticism in the Letters to the Editor, the authors who had originally looked at births from the 1998-2001 cohort, now looked at births from the 1999-2002 cohort, performing the same analysis but applying an intention to treat methodology. The paper entitled Neonatal Mortality for Primary Cesarean and Vaginal Births to Low-Risk Women: Application of an “Intention-to-Treat” Model was published in February 2008. As the authors explained:

… an “intention-to-treat” methodology, a methodology commonly used in medical research… [E]mergency cesarean sections performed after a woman was in labor would be combined with vaginal births to create a “planned vaginal delivery” category since the original intention of the physician and the mother in both cases was presumably to deliver the infant vaginally. The “planned cesarean delivery” group would include only those deliveries where a cesarean section was performed without labor.

This analysis led to very different results:

… In the most conservative model, the adjusted odds ratio for neonatal mortality was 1.6 (95% CI 1.35–2.11) for cesareans with no labor complications or procedures, compared with planned vaginal deliveries. Conclusions: The finding that cesarean deliveries with no labor complications or procedures remained at a 69 percent higher risk of neonatal mortality than planned vaginal deliveries is important, given the rapid increase in the number of primary cesarean deliveries without a reported medical indication.

So now instead of claiming that C-sections increase the risk by a factor of 3, they are claiming that C-sections increase the risk of neonatal death by only half that amount. But the authors still do not address the primary flaw of the study. They really have no idea which C-sections were indicated and which were not. The difference is critical. If only 0.002% of the remaining birth certificates were missing risk data, there would be no difference in mortality in the two groups at all. Based on what we know about the reliability of birth certificate data, there is reason to believe that far more than 0.002% of birth certificates lack the relevant data.

The bottom line is that MacDorman and colleagues never showed that C-section increased the risk of neonatal death by any amount.. They demonstrated an entirely different principle: garbage in, garbage out. When you apply statistical analysis to erroneous data, you reach unsubstantiated, erroneous conclusions.

Antithrombin deficiency is a hereditary disease causing low levels or defects of antithrombin, a blood protein required for controlling clot formation. Patients are at risk of blood clots, organ damage, and death. They usually have to take oral anticoagulant drugs like warfarin for life.

During high-risk procedures like surgery or childbirth, oral anticoagulants must be discontinued to minimize the chance of bleeding complications. While patients are off oral anticoagulants, they are given preventive treatment with antithrombin derived from pooled human blood. With any human blood product there is a small risk of infection with diseases like hepatitis C. And human antithrombin supplies are not plentiful.

Clever researchers found an ingenious solution. Put a human antithrombin gene in goats, milk them, isolate the human antithrombin protein from the milk, and voila! An udderly safe and plentiful source. A Brit might call it bleatin’ brilliant.

Yes, transgenic goats. No, they are not human/goat hybrids, despite a recent report that a goat had given birth to a human faun in Zimbabwe.

Sex between humans and animals does happen, but it can’t result in pregnancy because of the chromosome differences and other factors. 28% of men with bestial desires are attracted to goats. Goats come fourth after canines, equines and bovines.

You probably don’t know anyone who practices bestiality, but that doesn’t mean it doesn’t happen. I was e-mailed a video clip filmed by a Marine unit in Iraq, a light magnified night image (Improved Thermal Sight System). The marines were monitoring a known Taliban safe house. When they saw a suspect acting strangely, they thought he might be emplacing an IED. As they filmed him, they realized he was copulating with a donkey. They caught the whole thing on video. The best part is their comments as they watch the blurry images and gradually realize what they are seeing. It was apparently on YouTube briefly before it got banned. There is a similar clip with two Iraqis, one holding the donkey, that hasn’t been banned yet.  Of course, I can’t guarantee this isn’t video trickery. But in 2005 there was a well-documented case of a man who died after having sex with a horse just a few miles from where I live. Washington State is one of 17 states where sex with animals is not against the law. Instead of choosing a receptive female equine, this unfortunate man chose a stallion. The man died of a perforated colon; the horse suffered no physical damage, although I suppose we could speculate about possible psychological damage…  The whole thing was caught on videotape. Now there is even a movie. I report the facts without judgment: humani nihil a me alienum puto.

Pardon the prurient diversion. Back to the subject. Transgenic goats can’t be created by such “natural” methods: they require complicated tricky maneuvers in the lab. They are just like normal goats in every respect except that they produce one human protein, antithrombin. Still, it’s a wonder the religious fundamentalists haven’t been denouncing the evil scientists and bombing goat labs. Do they even know about this?

The recombinant human antithrombin is marketed under the brand name ATryn. It has been approved by the FDA for patients with antithrombin deficiency who are undergoing surgery or childbirth. Two clinical studies were done with 5 and 14 patients, respectively. Small studies, but it didn’t seem to call for a lot of investigation since it only amounted to replacing one of the patients’ own deficient proteins. No serious adverse events were reported.

The Medical Letter has evaluated ATryn (Volume 51, issue 1323, October 19, 2009. pages 83-63) and concluded it is a safe and effective source of replacement that may well turn out to have additional therapeutic applications.

Only one problem. It costs $2.34 per international unit, and patients in one study received anywhere from 39,200 IU to 294,000 IU. That adds up to $91,728 to $687,960 for one course of treatment for one patient. The manufacturer has a patient assistance program, but WOW! That’s a lot of money to protect one patient during childbirth! We don’t yet know how many patients will need to be treated to prevent one blood clot or save one life.

I can’t stop thinking about this. I am constantly amazed at the cost of some of the new drugs with limited applications, especially chemotherapy. And it’s not just the new, limited-use drugs. I recently got a prescription for what I thought was a cheap old antibiotic long available as a generic, and I was appalled at the price. It was more than ten times what I would have guessed.

It’s wonderful that science can accomplish such feats, and I have no ethical qualms about using goats as factories to help humans, but I wonder about the ethics of saddling society with unaffordable bills for treatments that provide only a small advantage. As we develop more of these expensive drugs, we could go bankrupt trying to provide them for every patient. It’s a dilemma that bears thinking about before it happens. One of the 4 basic principles of medical ethics is justice, or fair distribution of medical services to society.

However you look at it, our technical ability will eventually outrun our ability to pay.