Judy Mikovits: Unemployed and Bankrupt

And here I was thinking that Karma does not exist… – silly me.

So if we are lucky Dr. Mikovits will no longer be able to take advantage of a vulnerable patient population – one can dream.

Pity however that Lombardi and Ruscetti don't have the same luck as Saint Judy.

Komaroff and his Ampligen Vote

Anthony Komaroff voted against the FDA approval of Ampligen. Now there is some huffing and puffing in the ME/CFS blogosphere about this (which I will not dignify with a link): Some are writing that he is removed from the ME/CFS patient population (and that could as well be from Mars, not from Earth). Some paint him as a sort of underhanded malicious villain (and presumably bought by someone).

Personally, I think this is utterly stupid.

There is an article posted on "Medscape Medical News" (via) that sheds some little light on Komaroffs decision:

Anthony Komaroff, MD, Simcox/Clifford/Higby Professor of Medicine at Harvard Medical School, Boston, Massachusetts, voted no on both efficacy and safety. "As a physician who has cared for many of these patients for nearly a quarter of a century, nothing would please me more than solid evidence of an effective therapy, but I think there are enough questions about the conduct of the studies that it does not meet the standard of adequate evidence."

Even if I don't know the details behind his decision, I think his explanation is reasonable. It is reasonable to vote agains a drug, if one thinks that there are questions about the conduct of the drug studies. And my impression is that Anthony Komaroff never says or does anything without having the facts to back him up. If he says the FDA should not approve Ampligen, we should better listen.

And just because there is no currently approved drug for ME/CFS, that does not mean we should accept badly done drug studies.

What if Ampligen does not work as we hope? What if its efficiency or safety are actually worse than what the patient anecdotes suggest? In that case an approval could do us some serious harm. Directly, by harming patients who receive the drug and by costing money needed for proper research. And indirectly because "we" lobbied for an ineffective and/or dangerous drug. This would play right into the hands of the psychobabblers.

And what is really awful, that we see like in 2010 with the XMRV-fraud the same stupid behavior by "patient advocates" and "patient activists", who treat critics like villains. Case in point in 2010 was John Coffin who (rightfully) criticized Mikovits, who said nothing but the truth (and that in a very polite and unassuming manner), and who in turn was portrayed by "patient advocates" and "patient activists" as if he were the baby-eating-anti-christ himself.

And now it seems that Komaroff is the target of this misguided anger.

So, let me tell all those stupid "patient advocates" and stupid "patient activists" out there:
It is you, who are malicious. By ignoring valid criticism. By ignoring the valid reasons behind the criticism. By ascribing malicious motives to critics, motives that only exist in your head.

With friend like these "patient advocates" and these "patient activists", we don't need enemies.

The Great Chronic Lyme Mirage

I found some interesting comments by Phillip J. Baker (who seems to be associated with the American Lyme Disease Foundation) underneath an otherwise not recommendable article & discussion (or rather an article & discussion which can only be recommendable as a negative example for the display of confirmation biases and cognitive dissonances).

Especially this comment by Phillip J. Baker struck a chord with me:

Believe what you will, Phyllis, but you are wrong. Ceftiofur and ceftriaxone are chemically different in structure. Embers et al. have provided no assurances in their work that they have similar PK and PD properties, let alone the same MIC. It is incumbent upon them to provide such data, as well as to show that therapeutic regimen used was adequate to clear the huge inoculum that was used to produce a disseminated infection. Obviously, their experimental design did not mimic the Klempner study, which is what Mario was initially funded to do. Why he chose to use ceftiofur is for him to explain, not me. As I said before, ceftiofur has not been approved by the FDA for use in humans and there are no published data showing that it is effective for treating borreliosis in animals, let alone humans. There is one report showing that it is not effective for treating borreliosis in ponies.

Phillip J. Baker
on February 24, 2012 at 1:52 pm

http://lymedisease.org/news/lymepolicywonk/lymepolicywonk-was-this-important-lyme-study-hidden-for-12-years.html#comment-3798

He goes on to notice in another comment:

I must say that I find it strange that the term ceftriaxone is used throughout the Embers et al. paper, and it is only in the first paragraph on page 9 that it is first mentioned that ceftiofur was actually used. I find that very strange indeed.

So to claim that Lyme is still active despite anti-biotics, Embers et al. have to pull these two tricks:

1. Use a "huge inoculum" to intruduce an amount of pathogens not encountered in the wild, causing an "massive disseminated infection" not encountered in the wild.
2. Use an antibiotic that (most likely) is not effective in clearing the pathogen (let alone in this massive disseminated infection) – and hide that as good as you can.

What Phillip J. Baker describes are the tactics of quacks.

No wonder anybody with at least a couple of working brain cells left*, who looks into the matter comes to the conclusion that "Chronic Lyme" is a BS quack diagnosis.

And just for the record: I do think that these patients have an organic disease, which severely affects their lives – however there is no evidence** that this disease is Lyme. There are many many diseases that can cripple your live, and possibly some of which are yet of unknown.

* As to so called "Lyme Literate Medical Doctors" ("LLMD"):
They do not seem to have any working brain cells left. My (purely anecdotal and not evidence based) advise is to stay away from medical doctors who have no working brain cells. LLMD? Just say no. Choose a doctor instead with working brain cells, this is usually better for your health.

** As to any non-standard tests used to detect "Chronic Lyme": I can offer you an even more reliable Lyme test! I will match any price, just give me a call!

WTF? Beef and Somnolence?

The things you learn with an elimination diet, and then re-challenging with that food. My somnolence seems to have been caused by beef. Hmm.

I need more data to confirm or refute that. Hmpf.

Google Trends: Paleo vs. Weight Watchers

"Fad diet" my ass.

Ok, I cherry picked. Here's what it looks like with correct search terms:



Still, it's a nice upwards trend for Paleo, without the seasonal BS for Weight Watchers.

Needed Nutritional Intervention Studies

I was thinking that we need some nutritional studies with regards to pathogenic effects of evolutionary novel foods, and whether a evolutionary "correct" diet (aka "the" Paleolithic Diet or "Paleo" for short) can alleviate health problems.

Patients should receive nutritional intervention in the form of counseling and be assigned to one of two groups:

• The control group should receive counseling based on the consensus view on optimal nutrition. As the "gold standard" with regards to nutrition seem to be the advise from the U.S. Department of Agriculture(!) (USDA), from the American Heart Association (AHA) and from the American Diabetes Association (ADA), the control group should receive counseling based on their advise.
• The treatment group ("Paleo") should receive counseling based on the avoidance of foods containing evolutionary novel ingredients (more or less an "Elimination Diet" based on evolutionary plausibilty):
  1. Avoidance of cereal grains and soy
  2. Avoidance of dairy
  3. Avoidance of seed oils
  Pre-intervention levels of those four ingredients should be recorded. Calorie-countring should not be recommended, macro-nutritient ratios should not be prescribed, the diet should neither be low-carb, nor low-fat, nor low-meat – so the health effects of these four evolutionary novel food ingredients can be investigated. However, some minimum recommendations of what foods to primarily eat should be made.

Diseases should include the "Diseases of Affluence", but not be limited to them:

• Obesity (doh!)
• Type 2 Diabetes
• Asthma
• Hypertension
• Gout
• Acne*, Dermatitis, Psoriasis, etc.
• Allergies (Hay Fever and the like)
• Cardiovascular Diseases
• Depression
• Anxiety
• Other neurological/psychological/mental/etc. health problems (e.g. Bipolar Disorder)
• Multiple Sclerosis (MS), cf. Terry Wahls
• ME/CFS

A pilot study for each disease should include at least 10 patients from that chosen disease.

The dietary advise should be followed for 3 months, possibly with an extension to 6 and 12 months.

Objective markers for each disease (e.g. weight for obesity) should be recorded as the primary disease makers by the investigators before the study, at 1 month, and after that at each 3-month-point. Surrogate markers should be recorded in addition, but not for the primary measurement of outcomes.

Patients should have a simple food and symptom diary. If possible, the patient should be encouraged to record disease makers, both objective (e.g. daily activity level with an odometer, daily weight) and subjective (e.g. perceived fatigue).

After a patient stops a diet (either at the end of study, or patient drops out), she/he should be (if possible) followed for another month with regards the aforementioned disease markers and symptoms.

If positive health effects from an Paleo Diet are found for one disease, follow-up studies could be further refined with an focus on individual components (e.g. only dairy, or dairy from pasteurized* milk).

There is a lot do and many pitfalls to avoid before such studies would get off the ground…

* As I traced my acne back to dairy from pasteurized milk (and to a lesser extent to eggs), studies finding an positive effect of avoidance of dairy could further look into the difference between raw-milk dairy and pasteurized-milk dairy.

Carl Zimmer on The Evolution of Cavities

Carl Zimmer on The Evolution of Cavities:

… The Streptococcus mutans the scientists found in people’s mouths shared 1490 genes in common–a core genome, as it’s known. These shared genes varied from mouth to mouth, Stanhope found, with minor mutations sprinkled among them. It’s possible to tally up these mutations and use them to reconstruct some of the history of their ancestors. Stanhope and his colleagues found that Streptococcus mutans underwent a population explosion. And that explosion started ten thousand years ago.

It may well be no coincidence that this was also when our ancestors began to farm. Those early farmers shifted to diets dominated by corn and other grains–which turned the human mouth into an endless banquet of carbohydrates.

Stanhope and his colleagues were also able to pinpoint some of the genes that were important forStreptococcus mutans’s adaptation to civilization. Fourteen genes, for example, show signs of having experienced strong natural selection. Some of those evolved genes are essential for breaking down sugar. Others help the bacteria survive in the acidic conditions that arise in the mouth when we eat starches.

…

So Streptococcus likes our farming. Hmm.