Mighty May

Sunset over the Farne Islands (Graeme Duncan)

Mallard family on pond (Jamie Coleman)

Little Terns - up to 25 at roost (Jamie Coleman)

Lingering Black Redstart for third day (Jamie Coleman)

Swallows breeding back on Longstone (Jamie Coleman)

Monday 2nd May comments: How quick time fly’s when your having fun! Its crazy to think its now May – it only seems a few weeks ago we returned and here we are ready for the Arctic terns to settle! The season advances by the day and since the last update we’ve celebrated our first Kittiwake eggs and our first Shag chick! Alongside this success the first Sandwich Tern eggs have been found whilst Common and Arctic Terns continue to descend onto the islands daily and it won’t be long before they are settling on eggs themselves. More female Eider ducks are nesting whilst the cliff nesting species are more settled, with the majority of Auks now on eggs. On the visitor front, its been an amazing start as we’ve not lost a single day to bad weather in April whilst one or two ex-wardens have visited to say hello.

First egg dates:

Kittiwake 28th April
Razorbill 25th April

Puffin 15th April

Eider 12th April

Guillemot 10th April
Shag 23rd March

Recent bird highlights
Sun 24th Hooded Crow 1 west, Whitethroat (first of the year), Kestrel male and Pink-footed Goose 298 north in one skein

Tues 26th Sparrowhawk female, MARSH HARRIER female west towards the mainland

Fri 29th Manx Shearwater 5N (first of the year), Sparrowhawk male, Greylag Goose 8S, Whimbrel 2S (first of the year) and Tufted Duck 3N

Sat 30th Yellow Wagtail male, Chiffchaff 2, Willow Warbler 5, Black Redstart, Blackcap 3 and Lesser Whitethroat

Island Auction: Gladden Caye Belize

gladden-caye-1I have said it many times before, but Belize offers an excellent opportunity to purchase a Caribbean style island in a Caribbean climate, without paying the premium price often found in the West Indies. One of the newest islands to come on the market is Gladden Caye.

The price of 1-acre Gladden Caye in Belize is to be determined at a sealed bid auction! Bids are due on May 31st, 2011 at 12:00 P.M CDT.

Gladden Caye is in one of the most exclusive locations in Belize, right near the Gladden Spit, famous for Whale Shark diving. The island is located 24 miles east of Placencia and just behind the Belize Barrier Reef; There are two upscale luxury resorts about two miles away. The commute to the island takes about 35 minutes in good conditions and a little longer when the seas are rougher.

The island has a very rudimentary fisherman’s cabin on it with some basic infrastructure installed. The owner decided to paint it rather than remove it because a new owner could make good use of the house during initial stages of construction. The diving, snorkeling and fishing just off shore are phenomenal.

Mail or Deliver Sealed Bids to:

Alliance Bid 5542 137th Street SE Becker, MN 55308

Please call Alliance Bid with any Questions Regarding the Bidding Process: 800-262-5092

Call the Owner Directly for Property Details: 320-267-2219

Source: Private Islands Online.

Prince William and Kate Middleton: Private Island Honeymoon?

fregate_island_04Now that the Royal Wedding is over, people are speculating where the newly weds are planning on going for their honey moon.

 

Some have reported that the couple will jet off to Mustique the ultra exclusive island community in the Grenadines. However more recent reports suggest that the couple will enjoy their honey moon in the  Seychelles, the beautiful island archipelago off the coast of Africa.

 

Seychelles has a number of high end resorts private island resorts to choose from and their seclusion from the outside world will provide a measure of privacy for Will and Kate.

Although I do not know where they are staying, I have two guesses that would make excellent choices.

 

My first guess is Fregate Island  the posh island resort that has just 16 villas that start at 2,700 Euros per night. My other guess is North Island, a 462 acre with just eleven luxury villas.  Prices for North Island start at 1,835 Euros per night.

 

Which ever island they choose, I am sure it will be a fantastic experience.

VA Celebrates 65th Anniversary of Policy Allowing Medical School Affiliation – HNN Huntingtonnews.net


HNN Huntingtonnews.net
VA Celebrates 65th Anniversary of Policy Allowing Medical School Affiliation
HNN Huntingtonnews.net
HUNTINGTON, WV (HNN) - The Veterans Administrations continues celebration of Research Week, an event that includes recognition for affiliation of VA Hospitals with Medical Schools. Marshall University and the Huntington Veteran's Administration ...

and more »

UB will speed plans to move medical school – Buffalo News


Buffalo News
UB will speed plans to move medical school
Buffalo News
The University at Buffalo medical school could move downtown within the next few years, under a $350 million plan being fast-tracked by the university's new president. UB President Satish K. Tripathi wants to use $35 million in state seed ...
UB seeks funds for medical campus moveBizjournals.com
Good News from Albany: New Program Provides Initial Funding for First Phase of ...UB News Center

all 3 news articles »

Was Darwin killed by the very travels that helped him conjure theory of evolution? – Daily Mail


Daily Mail
Was Darwin killed by the very travels that helped him conjure theory of evolution?
Daily Mail
The British naturalist's ailments were the topic of an annual conference in the University of Maryland School of Medicine and Veterans Administration's Maryland Health Care System in Baltimore on Friday. In the lecture medical practitioners and even an ...
Historical Medical Conference Finds Darwin Suffered from Various ...PR Newswire (press release)

all 334 news articles »

Parasites

I saw a patient recently for parasites.

I get a sinking feeling when I see that diagnosis on the schedule, as it rarely means a real parasite.  The great Pacific NW is mostly parasite free, so either it is a traveler or someone with delusions of parasitism.

The latter comes in two forms: the classic form and Morgellons. Neither are likely to lead to a meaningful patient-doctor interaction, since it usually means conflict between my assessment of the problem and the patients assessment of the problem.  There is rarely a middle ground upon which to meet. The most memorable case of delusions of parasitism I have seen was a patient who  I saw in clinic who, while we talked, ate a raw garlic clove about every minute.

“Why the garlic?” I asked.

“To keep the parasites at bay,” he told me.

I asked him to describe the parasite.  He told me they floated in the air, fell on his skin, and then burrowed in.  Then he later plucked them out of his nose.

At this point he took out a large bottle that rattled as he shook it.

“I keep them in here,” he said as he screwed off the lid and dumped about 3 cups with of dried boogers on the exam table.

To my credit I neither screamed nor vomited, although for a year I could not eat garlic.  It was during this time I was attacked by a vampire, and joined the ranks of the undead.

I have seen the occasional earthworm thought to be an intestinal parasite. Sometimes people start to pay attention to their stool, often for the first time, and note  tube like structures  that move in the water.  Most likely mucous or undigested fiber wafting in the gentle currents of the toilet water.  Doesn’t that sound romantic? The contents of the average stool, like hot dogs and laws, are better left unexamined.  In those patients, an examination of the stool for worms and worm eggs is usually unrevealing and makes me glad I am not a microbiology technician.

Morgellons is, as best I can tell, a variant of delusions of parasitism.

Here is a thing about germs in general and parasites specifically: they have patterns and can be seen. There are patterns of disease and patterns of their life cycle.  You can tell when a disease is probably delusional because the “organisms” have no understandable pattern in the life cycle, the disease, the physiology, the anatomy or the epidemiology.

And germs can be seen. Well, most germs.  Single celled organisms can be tricky and may require special stains to be seen under the microscope.  Viruses are, of course, too small to be seen by a lab microscope. But parasites? Worms? These wee beasties are multicellular.  They are big. Not a long way to the chemists big, but sizable, not hard to see with a microscope unless they have Romulan cloaking technology.

So what is Morgellons?

Before we continue, I would like to clarify one thing. I see patients self diagnosed with Chronic Candida Syndrome or Morgellons or Chronic Lyme or some other process.  I do not doubt these people are ill and have symptoms that can be severe and life altering.  What I may disagree with the patient is the reason for these symptoms.  As best I can tell none of the above are due to an infectious disease.

Unfortunately when the patient is convinced they have an etiology for their symptoms and I think that their reason is nonsense, it does not lead to a therapeutic physician-patient interaction.  I try and phrase it as gently and non-judgmentally  as possible, but it rarely leads to a good time in the clinic.

Morgellons has existed as a disease since about 2002 and is an internet phenomena right up there with Rebecca Black.  See.  For a 54 year old man, I am hip. Morgellons received its name from a paper from 1935 called SIR THOMAS BROWNE AND THE DISEASE CALLED THE MORGELLONS By C.E. KELLETT, M.D., M.R.C.P. and published in Annals of Medical History, n.s., VII (1935), 467-479,  where it refers to a disease from the 1600′s (yes 1600′s) described by said Thomas Browne.

“Hairs which have most amused me have not been in the face or head, but on the Back, and not in Men but Children, as I long ago observed in that endemial Distemper of little Children in Languedock, called the Morgellons, wherein they critically break out with harsh Hairs on their Backs, which takes off the unquiet symptoms of the Disease, and delivers them from Coughs and Convulsions.”

Who know what these hairs/worms really were; the 1600′s were not a time noted for its diagnostic accuracy. Unlike the modern disease, it was usually a disease of children and often fatal, so whether these “hairs”  had anything to do with the disease or were actual living creatures, one cannot say.

In  1715 when the first microscopist, Leuvenhoeck, took a look at the bristles and thought them “inanimate”, starting a long tradition of looking at the detritus presented by Morgellons patients and seeing nothing.  I, for one, always look at the fluff brought in by Morgellons patients and have yet to see anything resembling a living creature. Diseases have come and gone in the past, like the English Sweating Sickness, so maybe there was a plague of virulent hairs (that’s hair not hare, it was not a virulent bunny, for which Hef is undoubtedly grateful), but no longer.

Fast forward 400 years.  Round about 2002 this disease was described on the net in regards a child with the symptoms now referred to as Morgellons, and since others have had the disease.  It is transmissible as an internet meme, but not spread person to person.

What are the distinguishing characteristics of Morgellons?  Here are features as noted from the Morgellons Research Foundation

1. “Filaments” are reported in and on skin lesions and at times extruding from intact-appearing skin. White, blue, red, and black are common among described fiber colors. Size is near microscopic, and good clinical visualization requires 10-30 X. Patients frequently describe ultraviolet light generated fluorescence. They also report black or white granules, similar in size and shape to sand grains, on or in their skin or on clothing. Most clinicians willing to invest in a simple hand held commercial microscope have thus far been able to consistently document the filaments.
2. Movement sensations, both beneath and on the skin surface. Sensations are often described by the patient as intermittently moving, stinging or biting. Involved areas can include any skin region (such as over limbs or trunk), but may be limited to the scalp, nasal passages, ear canals, or face…and curiously, legs below the knees.
3. Skin lesions, both (a) spontaneously appearing and (b) self-generated, often with pain or intense itching. The former (a) may initially appear as “hive-like”, or as “pimple-like” with or without a white center. The latter (b) appear as linear or “picking” excoriations. Even when not self-generated (as in unreachable regions of babies’ skin), lesions often progress to open wounds that heal incompletely (e.g., heal very slowly with discolored epidermis or seal over with a thick gelatinous outer layer.). Evidence of lesions persists visually for years.
4. Musculoskeletal Effects and Pain is usually present, manifest in several ways. Pain distribution is broad, and can include joint(s), muscles, tendons and connective tissue. Both vascular and “pressure” headaches and vertebral pain are particularly common, the latter usually with premature (e.g., age 20) signs of degeneration of both discs and vertebrae.
5. Aerobic limitation is universal and significant enough to interfere with the activities of daily living. Most patients meet the Fukuda Criteria for Chronic Fatigue Syndrome as well (Fukuda, Ann. Int. Med., 1994). Cardiology data and consistently elevated heart rates suggest a persistent myocarditis creating lowered cardiac output that has been partially compensated for by Starling’s Law.
6. Cognitive dysfunction, includes frontal lobe processing signs interfering with logical thinking as well as short-term memory and attention deficit. All are measurable by Standard Psychometric Test batteries.
7. Emotional effects are present in most patients. Character typically includes loss or limitation of boundary control (as in bipolar illness) and intermittent obsessional state. Degree varies greatly from virtually absent to seriously life altering. “

It is the filaments.  Over the years I have  seen a smattering of Morgellons and they bring in the filaments and I look at them under the microscope. I see hairs, and threads, and non-specific detritus, but never anything that resembles the results of a living creature. I have looked carefully at the skin of these patients, and have never seen an intradermal fiber.

So you can see why I am skeptical that this is anything but a version of delusions of parasitism.  In one series of 25 patients

Most patients in this study (23 out of 25) had prior psychiatric diagnoses (most determined by specialists) as follows: 11 out of 25 bipolar disease; 7 out of 25 Adult ADD; 4 out of 25 Obsessive Compulsive Disorder (OCD); and 1 out of 25 Schizophrenia.

The same study had a hodgepodge of lab abnormalities, but there were not compared to matched controls. It may well be that the patients have some underlying inflammatory process that causes skin lesions and a feeling of the creepy crawlies and are misidentifying standard environmental material as associated with the diseases.  But I am skeptical.

Against this hypothesis are the case reports where Morgellons is cured with Pimozide, an antipsychotic.  Delusions of parasitism is often treated with olanzapine, another antipsychotic, but others have suggested pimozide is superior.  Most infections would be unlikely to respond to antipsychotics, but I have never been satisfied with response to treatment as a means for confirming a diagnosis, that is a path better not followed without good reason. In my world docs often think if patients are improving on antibiotics the response is considered evidence of infection.  I know better. But given the lack of a demonstrable parasite, a response to psychiatric medications is certainly suggestive.

So response to anti-psychotics would suggest patients with Morgellons could have  a psychosis, but I keep in mind it does not necessarily extrapolate to all patients.  I try to bear in mind that when patients present with odd symptoms that they attribute to worms and parasites, it may be simple misunderstanding.

As of this entry, no one has fulfilled Kochs postulates with Morgellons.

For those not immersed in infectious diseases, Koccs postulates were a series of criteria to demonstrate the causality of infections,  Here there are, with the word filament substituted for microorganisms:

1) The filament must be found in abundance in all organisms suffering from the disease, but should not be found in healthy organisms.
2) The micro filaments must be isolated from a diseased organism and grown in pure culture.
3) The cultured filament should cause disease when introduced into a healthy organism.
4) The filament must be re isolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.

So far proponents of the disease are 0 for 4.

But if this disease is due something that can be visualized with the naked eye or a magnifying glass, it should be simple enough to characterize.  Lets say you are a DNP and a member of ILADS. Well, I have to admit that you have lost some credibility with me.  But lets say you saw a series of patients with Morgellons and you could see the fibersThere, right there. You can see them.  Would you not biopsy the fibers?  Would you not try to characterize them?  Nope.  So aggravating. It boggles the mind that someone could have a diagnostic coup right in front of them and let it pass.

Delusions of parasitism can be nosocomial. Well, not truly delusions, but patients can be convinced they have parasites when, in fact, they do not, and waste serious amounts of time and cash in pursuit of an imaginary diagnoses.

I recently saw a patient who had unexplained abdominal pain for a year and a half.  The patient had an extensive evaluation and no explanation for the symptoms, and,  looking for answers,  eventually wandered into the arms of a naturopath.

One of the shows my eldest liked to watch was I Love the 80′s on VH1.  The 80′s was the decade I was in medical school, residency and fellowship.  When I watched I Love the 80′s I recognized virtually nothing of popular culture of time.  Not the TV shows, the hair styles, the music. Nothing.   It really brought home how consuming becoming a doc and a subspecialist is.  A decade of my life was spent understanding medicine and infectious diseases. I am not complaining, mind you.  There are lots of reasons people go to an alt med provider, but I do not think gullibility is on the list.

The patient with the abdominal pain and their spouse are educated people, why would they see a naturopath?

Looking for answers.  Their areas of knowledge are totally removed from medicine and science, and while it is popular to bemoan the science illiteracy of the US population, and it is sorry, if your career arc was law, or finance or auto repair, or stoner at the 7/11,  are you going to find time to become literate in medicine?  Doubt it.  I can’t design a bridge or fly a jet.  Why would I expect someone who has mastered these tasks to understand medicine?  There are just so many hours in a day to accomplish tasks.

I have, as a further example, zero idea if my mechanic is giving me good diagnostic and repair advice on my car.  I have to take everything he says on faith.  I have neither the time or inclination to become expert in car repair, and most people do not have the time to become fluent in medicine.  Am I gullible?  I do not think so.

I had my epiphany years ago when I told a father of a meningitis patient, your daughter has an infection in the fluid that surrounds her brain and he replied, could you phrase that in a way I can understand it?  He had no idea of basic brain anatomy or infections, and why would he? So I drew him a picture.  It helped.

So anyway, the patient wandered  into the lair of a naturopath and was diagnosed with parasites.  Now mind you, the patient did not have symptoms that could be reasonably ascribed to parasites or worms, and, more importantly, had no risks for parasites or worms.  The industrialized West is reasonably free of worms and their brethren.  The naturopath did not do serology or blood work or even a simple stool study looking for the eggs of various worms.  It is how I, along with a history and physical looking for the pattern of disease that marks a parasite, come to a diagnosis. No, he or she (I do not remember the pronoun used at the time) proudly used electrodiagnosis.

Proudly.  As my patient related it to me, the naturopath, a graduate of Bastyr, (if there is an legitimate opportunity for a deliberate mispronunciation, it is with Bastyr) considered herself to be an expert in parasite treatment and diagnosis.

What is electrodiagnosis you ask?

There are many devices out there, so I do not know precisely which one the patient used.

My patient said they held an electrode in each hand, the naturopathic expert in parasitology twirled a dial, and told them that the reading indicated parasites. Really.  I am proud that I did not burst out laughing during the interview, as from my perspective it was a  ludicrous joke.  But, as I mentioned, not everyone knows what I do, and EEG’s and EKG’s can also diagnoses a variety of medical problems, so why not parasite infestation?

Electrodiagnosis are said to measure disturbances in the body’s flow of “electro-magnetic energy” along “acupuncture meridians” but are expensive galvanometers that measure electrical resistance of the patient’s skin when touched by a probe. Two pseudosciences in one.  I have seen better.   It is sometimes called electroacupuncture according to Voll, or EAV, and was pulled out of Dr. Volls backside in the 1950′s.

“The basic concept for all of the ElectroDermal screening devices, was the invention of Dr. Reinhardt Voll[1], who in the 1940s, discovered that the electrical resistance of the human body is not homogenous and that meridians existed over the body which may be demonstrated as electrical fields. Furthermore, he showed that the skin is a semi-insulator to the outside environment. By the 1950s Voll had learned that the body had at least 1000 points on the skin which followed the 12 lines of the classical Chinese meridians. Each of these points, Voll[2] called a Measurement Point (MP). Working with an engineer, Fritz Werner, Voll created an instrument to measure the skin resistance at each of the acupuncture points, patterned after a technique called Galvanic Skin Resistance (GSR). This was named Point Testing. In 1953, Voll had established the procedure that became known as Electro-Acupuncture according to Voll.”

There is zero validity to making any diagnosis this way. Except, of course, the E-Meter of Scientology.  I wouldn’t want to cross the them there Scientologists. Oh no, uh uh. No way.  E-meter forever. But those other electronic diagnostic devices? Pure bunkum.  I could not say it better than Quackwatch:

“The devices  are used to diagnose nonexistent health problems, select inappropriate treatment, and defraud insurance companies. The practitioners who use them are either delusional, dishonest, or both.”

That the  American Association of Naturopathic Physicians has a position statement on electrodiagnosis that considers it experimental is another sign that naturopaths have no business taking care of people.  To quote their position paper

“There are three levels of electro-diagnosis:
a. Meridian testing: Readings are interpreted in indicate strength of specific meridians, organ strength or physiologic function.
b. Remedy testing: Variations in readings are interpreted when remedies are given to the patient either orally, to hold or put on a “testing plate” wired to the electrodiagnostic equipment. Interpretations may include sensitivities, nutritional enhancement, or improved function.
c. Energy medicines: Electrodiagnostic equipment interprets information and manufactures an energy medicine which is given to the patient to take orally.
THEREFORE IT IS THE POSITION OF THE AANP THAT:
It is appropriate that the naturopathic profession pursue scientific research regarding the reproducibility and reliability .”

There is nothing on the Pubmeds on the validity of electrodiagnosis, and, on basic principals and prior probability, to suspect that electrodiagnosis would have any utility in the diagnosis of parasites  or anything other disease.

Despite this, my patient received prolonged courses of mebendazole, thiabendazole and praziquantel, all at half doses, and all out of pocket.

Uncertain of which parasite to kill, the naturopath tried to kill them all with under-dosed medications.  Good thing, come to think of it, that he did not use his infernal contraption to diagnose cancer, who knows how many anticancer treatments would have been prescribed.

And what is an energy medication and how does one manufacture them? Besides a triple shot of espresso?  The principals of EAV have been expanded for

“BioScan (remote DNA resonant testing) – This procedure utilizes extremely sensitive EAV computerized equipment to accurately measure stressors in the body. It bombards the clients sample DNA (usually hair) with up to 10,000 frequencies to locate bacteria, viruses, pesticides, heavy metals, industrial pollutants, chemicals, parasites, foods, allergies, dental materials, trees, weeds, pollens, inhalants, molds, yeast, fungus and many other substances that poison the environment today. These stressors and related deficiencies are identified in print form for the client along with the organs and glands affected by the stressors. Supplements are suggested that resonate with the test subject and homeopathics are customized to support the body to remove the stressors and return to homeostasis.”

Only 275 dollars, plus 5 dollars shipping and handling.  And they recommend a minimum of 4 evaluations.

Try as I might, I cannot write a satisfying concluding paragraph to this entry, so I will just stop.

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Marketing Pharmaceuticals in today’s Regulatory Environment

In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and more responsibility. All of that aside, I am now up to speed, and had the good fortune to be browsing the FDA’s website when I came across, the following article: “FDA issues warnings to marketers of unapproved ‘chelation’ products”. This seemed to me a good lead in to discuss the situation down at the FDA and why it is beneficial to have an outside party look at your marketing materials before you present them to the public.

In general, the promotional review process at the FDA works as follows. A Pharmaceutical, or CAM Company decides upon an advertisement they wish to have for their product. They review it internally to ensure compliance with the regulations as they understand them, then they send it to the FDA either as an informational piece or requesting a formal review. Which one they choose is dependent on how much of a risk they feel they are willing to take, which can also come down to the risk/benefit profile of the product in question. There is a group in each Center for the FDA which handles this. For the two Centers I have primarily dealt with on these issues, it is DDMAC (Division of Drug Marketing, Advertising and Communications) in CDER (Center for Drug Evaluation and Research) and APLB (Advertising and Promotional Labeling Branch, also pronounced “Apple-Bee”) in CBER (Center for Biologics Evaluation and Research). Now this is where the path between legitimate Pharmaceuticals and CAM takes a massive divergent twist.

Pharmaceuticals have a distinct disadvantage when it comes to marketing their products. For a Pharmaceutical advertisement to be acceptable, it must have three major parts to it, not including the biggest piece of all, FDA approval as a Marketable Product. The first of these, although it seems fairly obvious, is the Drug Name. After all, the consumer must know what product it is they are seeing information about. At this point both Pharmaceuticals and CAM are still relatively similar. The next two points is where divergence occurs.

The second most important tenet in Drug Marketing is having a truthful summary. This can be explained simply as the portion of the ad where the manufacturer tells you what the product does, and conforms to the product label. This is actually a good time to draw some attention to that word, “label”. In Regulatory terms, the label refers to not only the label on the actual medical packaging, but also that neatly folded origami-looking piece of paper that you get with your pill bottles, known as the Prescribing Information. The information contained in this label details the circumstances under which a drug should be prescribed, what adverse events are known and expected, effects on geriatric populations, pediatric populations, and pregnant populations. The list goes on, and it is all in the nice piece of paper. That label limits what claims can be said about a Pharmaceutical product.

For example, you cannot say, with a Pharmaceutical product for nasal decongestion that it cures cancer, as it is not in the label. Now, if there have been clinical trials done, and it shows that it does have effects on certain types of cancer, then you could make the claim, but you need accepted and peer-reviewed Science to back the claim. The same is not true for CAM. This is why, if you are a chronic insomniac like myself and you stay up way too late, you see products promising to cure every ill you may have from foot fungus to dehydration (water has been known to do this of course) to impotence.

It is telling that in some cases, these companies do get sued for their deceptive claims. One need only go so far as to look at Berkeley Neutraceuticals, the makers of Enzyte to see this. What they were really sued for was the false promise of “Double your money back” which they offered in their ads, however, it was entered during the trial that the product really did not perform as promised. I wonder if “Smiling Bob” is still smiling?

Another very key point to Pharmaceutical Advertising is what is known as fair balance, and here is where CAM comes up 100% deficient. The key to this is understanding that fair balance tells a complete picture of the story. It gives you both the negatives and the positives in your product. I am sure many of you have seen a drug advertised on television and been wondered about all those negative things that are mentioned. That is part of the fair balance, and it is required that Pharmaceutical companies tell you this. As most CAM is regulated under the Nutritional side of the FDA this fair balance does not exist. They are not under any obligation to say, for example, “Oh, my product contains only water, so while it may quench your thirst, it will not cure your cancer.”

This fair balance must also be clear and not misleading. This became a major issue back in 2008 when Robert Jarvik, M.D. began promoting Lipitor in television commercials. In the commercials, he used the line, “I’m glad I take Lipitor, as a doctor, and a dad.” This is a very very fine line that the FDA eventually stepped in on. Robert Jarvik is, indeed, a Medical Doctor. He did complete Medical School. What he did not do, and has never claimed to have done, is completed his medical internship/residency and is not licensed to prescribe. The FDA’s fear is that, since the advertisement began with the genial line of “I’m  Doctor Robert Jarvik, inventor of the Jarvik Artificial Heart.” that people would rely fully on Dr. Jarvik’s recommendation. After Pfizer was made aware of these concerns, they eventually pulled the advertisement. This is a beautiful case study on how one should always be careful not only of the message one is delivering, but also how that message is delivered.

As with everything where regulations are concerned, there are grey areas. This is where trained Regulatory Professionals come in, and we work to ensure that companies stay on the straight and narrow as much as is possible.

References:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229320.htm

http://www.casewatch.org/cp/enzytecmp.pdf

21 CFR 201

21 CFR 202

http://abcnews.go.com/GMA/OnCall/story?id=4138702&page=1

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European Union “Ban” On Herbal Products

Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

I find it interesting, and completely predictable, that sellers of herbal products are wailing that this is all a conspiracy by “Big Pharma” to crush the little guy and steal all the herbal profits for themselves, or to ban herbal products to protect their drug profits. But this is a straw man. The real question here is the balance between marketing freedom and quality control – but those who want to defend their right to sell herbs don’t want to discuss the real issues, apparently.

Dr Rob Verkerk from a trade organization, the ANH, is quoted as saying:

“Thousands of people across Europe rely on herbal medicines to improve their quality of life. They don’t take them because they are sick – they take them to keep healthy. If these medicines are taken off the market, people will try and find them elsewhere, such as from the internet, where there is a genuine risk they will get low quality products, that either don’t work or are adulterated.”

First, he begs the question that the use of herbs improves anyone’s quality of life. That is, in fact, the entire question – are the risks worth the alleged benefits. The legislation is simply an attempt to provide a better risk/benefit for the consumer by putting into play better assurances of safety.

His next point if the same point that is always made against regulation – if you make X illegal then people will just obtain X illegally or from less regulated sources. This is not specific to herbal products. There is a point there – regulation is not easy, especially with a global market and the internet. But that does not mean we should abandon all efforts at quality control and honesty in marketing.

He concludes with an assumption that herbal products under the current scheme work for anything and have adequate quality control – but again, that is the very issue. In fact regulations are generally not adequate to assure quality control in terms of dose and purity. And there is virtually no regulation about the claims that can be made for herbal products.

In the US the 1994 DSHEA essentially allows herbal manufacturers to make a host of pseudo-health claims without any oversight. The same is and will continue to be true in the EU. One could argue that this legislation does not go far enough to protect the public against false claims and useless products.

Others argue that this legislation will put the small producers out of business. This is exactly what patent medicine sellers complained about when the FDA was proposed. In fact all of the objections are identical to those raised against regulation of drugs. Of course, the point of the FDA was to put the mom and pop patent medicine sellers out of business – because they were largely selling snake oil and did not have the resources to perform proper safety and efficacy testing.

Here the claims are even less relevant – because herbal remedies are a multi-billion dollar industry, and the relative cost to get licensing is much less than getting a drug through the FDA.

What we really have here is an industry that wants to continue selling poorly regulated products with health claims and without any burden of having to prove that their products are safe or that their health claims are based upon science.

I acknowledge that there is a real political debate here, and that some people might want to favor freedom and risk over government regulation. But I object to the way the debate is often framed by opponents to regulation. Even for those who would prefer to have a free market for herbal products would likely agree that the consumer deserves accurate information in order to make informed decisions. Right now, in most markets, the consumer does not have that.

Most people I talk to about this assume that herbs are more regulated than they currently are. People want both freedom and protection, and are not always aware of the degree to which the two are at cross purposes. So if you ask them if they want freedom in the market, they say yes. And if you ask them if they want assurance of safety and honesty, they also say yes. They want the freedom to choose, but only among products that are safe and effective.

With respect to herbal remedies, however, the evidence is largely against the efficacy that is being claimed for many products. If you look at the big sellers, like echinacea and Gingko biloba, the large well-controlled studies are largely negative – they don’t appear to work for the indications for which they are commonly marketed.

The industry has largely failed to self-regulate, and to use their profits to generate good science to back up their claims. And they consistently fight against regulation to force them to do so, and try to make it seem like they are on the side of the little guy against big corporate interests. But this is just spin – they are just another big industry protecting their interests. If they really cared about the little guy or the consumer they would be producing good science, and keeping their claims within the evidence, rather than fighting against attempts to make them do just that.

Under most current regulatory schemes, there is a disincentive to conduct good efficacy research. Such research is a lose-lose proposition for industry. They have to spend the money to do the research. If it’s positive, it is unclear how that will benefit them since they already can make health claims (or pseudo-health claims, like the so-called “structure function” claims under DSHEA). But if it’s negative, then they risk losing market share. The risk/benefit of doing efficacy research is simply not there, and that is probably why there is so little such industry-sponsored research into supplements. The only way to get the industry to spend some of their profits doing quality research is to make such research a requirement for entry into the marketplace.

In the end we should remember that herbs are drugs – they have pharmacological activity, they have toxicity, an they have drug-drug interactions. How much regulation and quality assurance do we want for our drug industries (no matter what they are called)?

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Hash Oil for Gliomas? What Would You Do?

A friend asked me to look at the evidence for hash oil as a treatment for glioma. His teenage daughter was recently diagnosed with brain cancer: a grade 3 anaplastic ependymoma. It recurred very rapidly after surgery and radiotherapy and the latest tissue diagnosis shows an aggressive grade IV glioma. Her prognosis is not good. No further attempts at curative therapy are indicated; the oncologist prescribed only palliative therapy with temozolomide. Her father, who had recently lost his wife to cancer (breast cancer metastatic to lungs and brain), was understandably devastated. As he puts it, he remains “focused on the belief that just maybe a cure can be found.” He stumbled on what he calls “earth-shattering news” regarding hash oil. He and his friends established a private wiki website which they are constantly updating with information about THC (tetrahydrocannabinol, the active ingredient in marijuana and hash) and other possible cancer cures: everything from curcumin to diet. He asked me to look at the information he has accumulated. He said

I hope to convince you in the same way I have done with my daughter’s GPs and her neuro-oncologist at BC Children’s Hospital.

The oncologist was not exactly convinced. He didn’t say he thought hash oil was likely to work; he only said it would be reasonable to try it as a complementary therapy. He said

the data published so far appears very preliminary, most of its potential effectiveness in vivo so far appears in colonic disease, having said that there doesn’t appear to be any obvious down side as a complementary therapy and may have synergistic effect, so may be reasonable as add on to temodal if she tolerates it

I wasn’t convinced either.

I will discuss two issues here:

  1. What does the evidence say about gliomas and hash oil?
  2. When is it reasonable to try an unproven treatment as a last resort?

What Does the Evidence Show?

Several plausible mechanisms have been demonstrated, suggesting that it might work; but the evidence consists almost entirely of in vitro (test tube) and animal studies, with only a couple of small pilot studies in humans and a lot of speculation.

The Guzman study was a pilot study of 2 patients who got THC injected directly into their tumors.

The Salazar study concluded

we identify what we believe is a new route that links the ER stress response to the activation of autophagy and promotes the apoptotic death of tumor cells. The identification of this pathway will help to understand the molecular events that lead to activation of autophagy-mediated cell death by anticancer drugs and may contribute to the design of new therapeutic strategies for inhibiting tumor growth.

The Kogan study elucidates cellular anti-cancer mechanisms of THC but warns “sometimes they can act also as pro-cancer agents, especially in low concentrations, acting mostly through growth factors and their receptors activation/induction.” It concludes

In summary, cannabinoids possess some anticancer activity. Possibly they may represent a new class of anticancer drugs that retard cancer growth, inhibit angiogenesis and the metastatic spreading of cancer cells.

None of these studies concluded that we should be treating glioma patients with any form of THC.

A study by Foroughi reports spontaneous regression in 2 glioma patients. One happened to have smoked pot almost every day, the other used it twice a week. They speculate that the THC might have had something to do with the regression. But it might just as well have been coincidental. Spontaneous regression is known to occur in gliomas. A 2004 German study showed spontaneous regression in a mouse model. A study in the Archives of Ophthalmology documented 13 cases of spontaneous regression in humans with large optic gliomas.

The literature is confusing because it addresses different doses, different compounds, and different routes of administration: THC, smoking pot, hash oil, injecting it directly into tumors, applying it topically to skin tumors, inhaling, taking it by mouth, etc. Positive pilot studies are an encouragement to further studies; they are not proof that the treatment works.

The information on the Internet includes glowing testimonials but is contaminated with obvious bias. Advocates come mostly from the ranks of notorious “legalize marijuana” activists. Emotions run high. Many arguments in favor are full of the kind of fallacies we often discuss here, including “they didn’t listen to Semmelweis.” Protestations that THC research is being unfairly suppressed are not credible. Cancer researchers want to find cures, and even Big Pharma stands to reap huge benefits if active molecules can be separated out, modified, and turned into prescription drugs.

I didn’t find anything I would call “earth-shattering” or even anything that could be considered credible evidence that hash oil can cure advanced gliomas. The most I can conclude from my research is that hash oil has promise and is worth studying.

Last Resort?

When a patient is out of options, it is natural to grasp at any straw. Even though the evidence for hash oil is inadequate, there are some preliminary indications that it might help, and some plausible mechanisms have been elucidated. Isn’t it better to try something that possibly might work than to just give up?

How do you know what to try? The private website addresses all kinds of other possible cancer treatments, including curcumin, garlic, diet, etc. Incidentally, it cites a lot of very untrustworthy sources, such as a book by a doctor who repeats the old myth about cancer and sugar and a company that is selling curcumin pills. Should you try all of these treatments at once? If you try hash oil, how do you decide how much and how often?

We read articles in the popular press, for instance in Reader’s Digest, about the child with the rare disease whose heroic parents refused to give up and kept searching until they found the one doctor in the world who was able to cure their child with a new treatment. We hear about these success stories because they are unusual.

We don’t hear about the vast majority of cases where parents wasted time and money in a futile search.

It disturbed me to read through the private wiki, because it was “déjà vu all over again.” I’ve seen this so many times. Someone desperately wants to find a cure, latches onto something that he thinks might work, locates a mass of evidence to confirm his bias, but fails to appreciate the limitations of that evidence and fails to seek out information that argues against his bias (like the possibility that cannabinoids might have pro-cancer effects, mentioned above). In the course of my long career I’ve seen so many promising treatments bite the dust that I have become not only skeptical but probably cynical about it.

Yes, hash oil might be an effective treatment for gliomas and for other cancers. But we can’t possibly know until we test it properly. A patient with glioma today can’t wait for the results of future tests. Forgoing the treatment might mean dying sooner than necessary, but it is far more likely that using the treatment will be useless. It’s a gamble. Where is that crystal ball when we need it?

When you try a treatment on your own, you are essentially acting as a guinea pig in an uncontrolled experiment. Ideally, you could enroll in a randomized controlled trial that would result in some useful knowledge for future patients. But such trials are not always available, and you might not get the treatment; you run the risk of being assigned to the placebo group.

Is aggressively pursuing a cure really the best goal? Success is possible but very unlikely; and the search can become obsessive; dominate the searcher’s life; and consume time, funds, and energy that might be best employed otherwise. How about pursuing other goals that have a much higher chance of success: spending quality time with the loved one, trying to make the most of whatever time she has left, helping her cope, trying to make her remaining life as worthwhile as possible, saying goodbye, creating good memories for the survivors?

I’m going to be mean and ask some difficult questions. Is this father really doing this for his child or for himself? He wants to be able to say he did everything possible and left no stone unturned, so he will have no guilt feelings afterwards. Is the daughter really on board with all this, or is she cooperating mainly to please her father, knowing that it gives him comfort? Is she giving up the foods she loves to follow a restricted diet that has no proven benefit? Would it be better for all concerned to accept the terrible prognosis and confront its reality in more constructive ways? Do false hopes do more harm than good? There are always real hopes: that palliative therapy might extend life, that a spontaneous regression might occur, that life might still be rich with meaningful experiences?

Conclusion

Hash oil has enough promise to warrant further research but not enough evidence to warrant prescribing it as a cancer cure. Is it worth trying anyway? I don’t know. I am asking questions, not condemning. I can’t imagine what it is like to learn that your beloved child has a fatal illness. I don’t know how I would react, or whether I would want to try something like hash oil. It’s possible that I might feel desperate enough that all my judgment, skepticism, and common sense would fly out the window and I might be persuaded to try even the most wildly irrational things. I do know that refusing to accept reality often has unfortunate consequences. It distresses me when families aggressively pursue a will-o’-the-wisp that ends in failure and uses up precious time they might have spent otherwise to make the patient’s last days more meaningful and to create lasting memories.

What would you do? I welcome readers’ input in the comments.

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“Motivated reasoning,” alternative medicine, and the anti-vaccine movement

One theme that we at Science-Based Medicine keep revisiting again and again is not so much a question of the science behind medical therapies (although we do discuss that issue arguably more than any other) but rather a question of why. Why is it that so many people cling so tenaciously to pseudoscience, quackery, and, frequently, conspiracy theories used by believers to justify why various pseudoscience and quackery are rejected by mainstream science and medicine? Certainly, I’ve touched on this issue before on several occasions, for example, with respect to the anti-vaccine movement, the claim that abortion causes breast cancer, and how we as humans crave certainty.

It turns out that science and science-based medicine are hard for humans to accept because they often conflict with what our senses perceive and brains interpret as irrefutable evidence. The pattern-seeking function of our brain, when evaluating questions of causation in medicine, frequently betrays us. For instance, when a parent sees her child regress into autism sometime not long after being vaccinated, the easiest, most instinctive, and most emotionally compelling conclusion is that the vaccine must have had something to do with it. When scientists tell her that, no, in large studies looking at hundreds of thousands of children, there is no good evidence that vaccination confers an increased risk of autism and a lot of evidence that it does not, it’s a very hard message to believe, because it goes against how the parent interprets what she’s seen with her own eyes. Indeed, how often have we seen believers in the vaccine-autism link pour derision on the concept that when something like autistic regression happens in close temporal proximity to vaccination that the correlation does not necessarily equal causation? Similarly, believers in “alternative medicine” who experience improvement in their symptoms also pour derision on the observation, explained so well by R. Barker Bausell in Snake Oil Science, that people frequently take remedies when their symptoms are at their worst, leading them to attribute natural regression to the mean to whatever nostrum they started taking at the time.

These issues have come to the fore again, thanks to an article by an acquaintance of mine, Chris Mooney, author of The Republican War on Science, Storm World: Hurricanes, Politics, and the Battle Over Global Warming, and Unscientific America: How Scientific Illiteracy Threatens our Future (co-authored with Sheril Kirshenbaum). The article appeared in a recent issue of Mother Jones and was entitled, rather ironically, The Science of Why We Don’t Believe Science. Chris made his name as an author primarily in writing about the science of anthropogenic global warming and the political battles over policies intended to mitigate it and, to a lesser extent, over creationism and evolution denial. Of late he has written about the anti-vaccine movement as an anti-science movement, leading predictably to his being attacked by the likes of J.B. Handley as viciously as I and others have. Also of note, although he was widely praised for The Republican War on Science and Storm World, Mooney has been widely criticized in some circles for being too critical of “new atheists” and for lack of substance. In his current article, he discusses some of the science thus far about why people can cling to beliefs that science doesn’t just cast doubt upon but shows convincingly are totally wrong.

Motivated reasoning

In his article, Mooney sets the stage with a very famous example studied by Stanford University psychologist Leon Festinger in the 1050s of the Seekers. The Seekers were an apocalyptic cult in the Chicago area led by a Dianetics enthusiast named Dorothy Martin. Its members believed that they were communicating with aliens, one of whom was named “Sananda,” who was supposedly the astral incarnation of Jesus Christ. Martin also taught her followers that Sananda had told her the precise date of a world-ending cataclysm: December 21, 1954. As a result, some of Martin’s followers quit their jobs and sold their homes because they expected that a spaceship would rescue them right before the earth split open and the sea swallowed much of the United states. In fact, Martin’s followers even went so far as to rid themselves of all traces of metal, even removing underwire bras and taking the zippers out of their clothes, because they were told that such metal would pose a danger to the spaceships. Here’s Mooney’s account of what happened when December 21, 1954 came and went and, as those of us living today know, no cataclysm occurred:

At first, the group struggled for an explanation. But then rationalization set in. A new message arrived, announcing that they’d all been spared at the last minute. Festinger summarized the extraterrestrials’ new pronouncement: “The little group, sitting all night long, had spread so much light that God had saved the world from destruction.” Their willingness to believe in the prophecy had saved Earth from the prophecy!

From that day forward, the Seekers, previously shy of the press and indifferent toward evangelizing, began to proselytize. “Their sense of urgency was enormous,” wrote Festinger. The devastation of all they had believed had made them even more certain of their beliefs.

In the annals of denial, it doesn’t get much more extreme than the Seekers. They lost their jobs, the press mocked them, and there were efforts to keep them away from impressionable young minds. But while Martin’s space cult might lie at on the far end of the spectrum of human self-delusion, there’s plenty to go around. And since Festinger’s day, an array of new discoveries in psychology and neuroscience has further demonstrated how our preexisting beliefs, far more than any new facts, can skew our thoughts and even color what we consider our most dispassionate and logical conclusions. This tendency toward so-called “motivated reasoning” helps explain why we find groups so polarized over matters where the evidence is so unequivocal: climate change, vaccines, “death panels,” the birthplace and religion of the president (PDF), and much else. It would seem that expecting people to be convinced by the facts flies in the face of, you know, the facts.

I’ve actually written about motivated reasoning before a couple of years ago. At the time, I used a then-recent study that examined how impervious to evidence certain beliefs about politics were, specifically the belief that Saddam Hussein had been involved in planning 9/11, conspiring with Al Qaeda to destroy the World Trade Center twin towers (the “9/11 Truth” movement). In this study, even President George W. Bush’s own words stating that Hussein was not involved in planning 9/11 were not enough to convince believers. Another study cited used similar methodology regarding Saddam Hussein’s lack of weapons of mass destruction. In fact, in this study, there was a “backfire” effect, in which those exposed to disconfirmatory information about Saddam Hussein’s involvement with 9/11 were actually more likely to believe that he was, in fact, involved. Also discussed was the belief that President Barack Obama was not born in the United States and is therefore not eligible to be President (the “Birther” movement, which recently suffered a bit of a setback) and the belief that there were “death panels” written into the recently passed Patient Protection and Affordable Care Act. In the study I discussed, the authors based their analysis of motivated reasoning on its being driven primarily by cognitive dissonance, the the feeling we have when we are forced to become aware that we are holding two contradictory thoughts at the same time. The strength of the dissonance depends upon the importance of the subject to an individual, how sharply the dissonant thoughts conflict, and how much the conflict can be rationalized away, and cognitive dissonance theory thus posits that, when faced with evidence or occurrences that challenge their beliefs, people will tend to minimize the dissonance any way they can without giving up those beliefs.

To the list of examples provided by the authors, I also added the example of someone well-known to this blog, namely Andrew Wakefield, the (in)famous British gastroenterologist who in 1998 published a study in The Lancet that claimed to find a link between the MMR vaccine and “autistic enterocolitis.” When revelations of Wakefield’s financial fraud came to light, however, his fans in the anti-vaccine movement were motivated to cling all the more tightly to him, circling the wagons and attacking anyone who had the temerity to point out his fraud, bad science, bad medicine, and massive conflicts of interest. For example, just last month, in response to criticism of Andrew Wakefield, J.B. Handley, the founder of the anti-vaccine group Generation Rescue, pointed out that people like him view Andrew Wakefield as “Nelson Mandela and Jesus Christ rolled up into one.” Never mind that, scientifically speaking, Wakefield is just as discredited in his science as Dorothy Martin was in her predictions of global destruction. In the same article, anti-vaccine activist Michelle Guppy warned the reporter direly, “Be nice to him, or we will hurt you.” As you can see, despite the drip, drip, drip of allegations and evidence showing Andrew Wakefield to be a horrible scientist and even a research fraud have not had much of an effect on committed activists. I would argue, however, that they did have a significant effect on the media and the fence-sitters.

For the most part, most scientifically literate people know what cognitive dissonance is, but what is “motivated reasoning”? According to Mooney, to understand motivated reasoning, you first have to understand that what we humans call “reasoning” is not a cold, emotionless, Mr. Spock-like process. The way we human beings reason is actually suffused with emotion, or affect:

Not only are the two inseparable, but our positive or negative feelings about people, things, and ideas arise much more rapidly than our conscious thoughts, in a matter of milliseconds—fast enough to detect with an EEG device, but long before we’re aware of it. That shouldn’t be surprising: Evolution required us to react very quickly to stimuli in our environment. It’s a “basic human survival skill,” explains political scientist Arthur Lupia of the University of Michigan. We push threatening information away; we pull friendly information close. We apply fight-or-flight reflexes not only to predators, but to data itself.

We’re not driven only by emotions, of course—we also reason, deliberate. But reasoning comes later, works slower—and even then, it doesn’t take place in an emotional vacuum. Rather, our quick-fire emotions can set us on a course of thinking that’s highly biased, especially on topics we care a great deal about.

As a result, if this hypothesis is accurate, it can be expected that people will almost always respond to scientific or technical evidence in a way that justifies their preexisting beliefs. Examples of evidence that support this hypothesis are listed, including the study I discussed two years ago using the example of the persistent belief that Saddam Hussein had a hand in engineering 9/11. Also discussed was a classic study from 1979 in which pro- and anti-death penalty advocates were exposed to two fake studies, one supporting and one refuting the hypothesis that the death penalty deters violent crime. In addition, they were also shown detailed scientific critiques of each study that indicated that neither study was methodologically stronger than the other. In each case, advocates were more likely to find the study that supported their bias more convincing and to be more critical of the one that did not.

To anyone who understands human nature, this is not particularly surprising. After all, as Simon & Garfunkel sang in their 1970 song The Boxer (one of my all time favorite songs), “a man hears what he wants to hear and disregards the rest.” That’s not quite motivated reasoning, but close. Motivated reasoning would be more along the lines of saying, “a man pays attention to information that supports his beliefs and values and finds ways to disregard or discount the rest.” This principle, more than anything else, probably explains why believers in alt-med and anti-vaccine activists are immune to disconfirming evidence. Not just immune, either, they actively seek out confirming evidence and avoid disconfirming evidence, a task made much easier by the Internet and multiple different news outlets catering to different ideologies:

Okay, so people gravitate toward information that confirms what they believe, and they select sources that deliver it. Same as it ever was, right? Maybe, but the problem is arguably growing more acute, given the way we now consume information—through the Facebook links of friends, or tweets that lack nuance or context, or “narrowcast” and often highly ideological media that have relatively small, like-minded audiences. Those basic human survival skills of ours, says Michigan’s Arthur Lupia, are “not well-adapted to our information age.”

We see this in the CAM movement. An entire network of websites and blogs has sprouted up over the last decade or so. CAM believers, if they wish, can peruse sites like NaturalNews.com, Mercola.com, and Whale.to, watch television shows like The Dr. Oz Show, and never see a single piece of information or study that challenges their world view that because it’s natural it must be better, that conventional, scientific medicine is hopelessly in the thrall of big pharma, and that modalities that are nothing more than magical thinking can cure disease. Similarly, anti-vaccine activists have their own set of websites, including Generation Rescue, Age of Autism, the NVIC, the Orwellian-named International Medical Council on Vaccination (formerly “Medical Voices,” and discussed by Mark Crislip and myself), SafeMinds, and many others. These CAM and anti-vaccine sites also have their own scientific-seeming meetings, such as Autism One (which, by the way, is fast approaching again) and the AANP.

Wrapped safely in such a cocoon, believers seldom encounter arguments against their cherished beliefs, much less strong arguments against them. No wonder they’re often so poor at defending their favorite woo when they dare to stray out of the safe confines of their little world. However, one interpretation of motivated reasoning that I’ve come up with states that you don’t actually have to be good at producing arguments that convince other people; you just have to be good enough to cherry pick arguments that convince yourself.

Politics, CAM, and the anti-vaccine movement

While Mooney’s summary for the evidence for motivated reasoning is compelling, he stumbles a bit in trying to ascribe different forms of motivated reasoning to the right and the left. While it is clear that certain forms of anti-science do tend to cluster either on the right or the left (for example, anthropogenic global warming denialism is definitely far more common on the right), if motivated reasoning is a valid hypothesis that describes well how human beings react to information that challenges their belief systems and values matter more (at least initially) than facts and science, then it would only be expected that certain forms of science would be viewed more hostilely by the right than the left while other scientific findings would be viewed more hostilely by the left. Unfortunately, one of the examples Mooney picks is fairly dubious:

So is there a case study of science denial that largely occupies the political left? Yes: the claim that childhood vaccines are causing an epidemic of autism. Its most famous proponents are an environmentalist (Robert F. Kennedy Jr.) and numerous Hollywood celebrities (most notably Jenny McCarthy and Jim Carrey). The Huffington Post gives a very large megaphone to denialists. And Seth Mnookin, author of the new book The Panic Virus, notes that if you want to find vaccine deniers, all you need to do is go hang out at Whole Foods.

It’s hard not to note right here that the founder of Whole Foods, John Mackey, is an anti-union Libertarian and admirer of Ayn Rand. In any case, I really hate it when people like Mooney try to pin anti-vaccine views as being mainly “on the left.” True, left-leaning crunchy types are the primary face of anti-vaccine views, but there is an entire underground on the right that is virulently anti-vaccine. These include General Bert Stubblebine III‘s Natural Solutions Foundation, far right libertarians, and others who want to protect their “purity of essence.” In addition, FOX News isn’t above pushing anti-vaccine nonsense. For example, of late the FOX and Friends crew has been doing sympathetic pieces on Andrew Wakefield, interviews with Dr. Bob Sears, SafeMinds’ anti-vaccine PSA campaign, Louise Kuo Habakus (who is virulently anti-vaccine herself and politically active in New Jersey pushing for transparent “philosophical exemption” laws. Politically, some of the most rabid anti-vaccine activists in government are conservative, for instance Representative Dan Burton. Moreover, conservative fundamentalist religion is not uncommonly a motivation for anti-vaccine views. Not surprisingly, Mooney’s example ignited a rather intense debate in the blogosophere, which included Mike the Mad Biologist, Razib Khan, Joshua Rosenau, Andrew Sullivan, David Frum, and Kevin Drum, among others.

This debate didn’t go very far in either direction because there aren’t actually a lot of good data examining whether there is a correlation between political affiliation and anti-vaccine views. Ultimately, Mooney followed up with a post on his blog in which he did the best he could do with polling data on the politics of vaccine resistance. Reanalyzing a poll from 2009 asking about Jenny McCarthy’s anti-vaccine views, specifically how many people were aware of them and how many were more or less likely to agree with them, Brendan Nyhan and Chris Mooney found:

So here are the results: Liberals (41% not aware, 38 % aware but not more likely, 21 % aware and more likely); Moderates (48% not aware, 28% aware but not more likely, 24% aware and more likely); Conservatives (49% not aware, 28 % aware but not more likely, 23% aware and more likely).

These results basically suggest that there’s little or no political divide in terms of who falls for Jenny McCarthy’s misinformation. Notably, liberals were somewhat more aware of her claims and yet, nevertheless, were least likely to listen to them. But not by a huge margin or anything.

Mooney also noted another poll done by Pew regarding whether vaccines should be mandatory:

What’s interesting here is that Pew also provided a political breakdown of the results, and there was simply no difference between Democrats and Republicans. 71% of members of both parties said childhood vaccinations should be required, while 26% of Republicans and 27% of Democrats said parents should decide. (Independents were slightly worse: 67% said vaccinations should be required, while 30% favored parental choice.)

Bottom line: There’s no evidence here to suggest that vaccine denial (and specifically, believing that childhood vaccines cause autism) is a distinctly left wing or liberal phenomenon. However, I will reiterate that we don’t really have good surveys at this point that are clearly designed to get at this question.

Even though the evidence is admittedly weak and more studies and surveys would definitely be in order, Mooney’s conclusion is nonetheless in line with my experience. I’ve said before many times that anti-vaccine views are the woo that knows no political boundaries. Although I don’t have hard scientific data to support this my contention and therefore can’t definitively discount the possibility that my observations represent confirmation bias, I’ve noticed that right wing anti-vaccine activists tent to be suspicious of the government and appeal to “health freedom” as a reason for their resistance to vaccination, and tend to eschew any societal obligation to contribute to herd immunity. Left wing anti-vaccine activists tend to be suspicious of big pharma and believe that vaccines are somehow “unnatural.” I realize my interpretation might be biased, but until better data are available it’s all I have to work with. Similarly, alternative medicine use tends not to fall into an easy left-right dichotomy either. My favorite example to illustrate this point is that, even though alternative medicine is viewed as a crunchy, “New Age” phenomenon more prevalent on the left, the Nazi regime actively promoted naturopathy and various other “volkish” alternative medicine modalities. I trust that now someone will invoke Godwin’s law, but forgive me; I was intentionally using an extreme example to illustrate my point that all parts of the political spectrum can be prone to quackery.

Finally, Mooney makes another point that I quibble with:

Well, according to Charles Taber and Milton Lodge of Stony Brook, one insidious aspect of motivated reasoning is that political sophisticates are prone to be more biased than those who know less about the issues. “People who have a dislike of some policy—for example, abortion—if they’re unsophisticated they can just reject it out of hand,” says Lodge. “But if they’re sophisticated, they can go one step further and start coming up with counterarguments.” These individuals are just as emotionally driven and biased as the rest of us, but they’re able to generate more and better reasons to explain why they’re right—and so their minds become harder to change.

I would quibble somewhat with whether, in the case of science and medicine at least, that apparent “sophisticated” understanding of the issues possessed by ideologues is actually as sophisticated as it appears on the surface. In some cases it might be, but far more often it’s a superficial understanding that has little depth, mainly because few lay people have the detailed scientific and medical background to apply the information. It’s often a matter of knowing facts, but not having the scientific experience, understanding of mechanisms, or sophistication to put them in context or to apply them to the situation properly. Thus, the arguments of, for instance, anti-vaccine advocates often have the veneer of scientific sophistication, but to those knowledgeable about vaccines are easily identified as utter poppycock. Examples abound, and include this “review” article by a man named David Thrower is, and every “scientific review” published by, for example, Age of Autism.

I can’t remember how many times that, while “debating” in misc.health.alternative, I would have a study quoted to me as supporting an antivaccination or other alternative medicine viewpoint and find that, when I actually took the trouble to look up the study and download the PDF of the actual article rather than just reading the abstract (which is all most lay people have access to and therefore all they read), I would find a far more nuanced and reasonable point or even that the article didn’t support what the altie was saying. One other aspect that often comes into play is an extreme distrust of conventional medicine and/or the government such that few individual studies that question the safety of vaccines are given far more weight in their minds than the many more studies that show vaccines to be extraordinarily safe or large metanalyses. Certainly this is one reason why the infamous Wakefield study, despite being shoddily designed and now thoroughly discredited, keeps rearing its ugly head again and again and continues to be cited by antivaccination activists as strong evidence that the MMR vaccine causes autism. Basically, what is happening here is that highly intelligent and motivated people can construct arguments that seem better to the uninformed.

One thing that must be remembered about motivated reasoning is that we as skeptics and supporters of science-based medicine must remember that, as human beings, we are by no means immune to this effect. Indeed, as Mooney points out, citing recent research, it’s quite possible that reasoning is a better tool for winning arguments than it is for finding the truth, and when motivated reasoning combine with the echo chamber effect of modern social groups bound together by the Internet and like-minded media, the result can be disastrous for science:

But individuals–or, groups that are very like minded–may go off the rails when using reasoning. The confirmation bias, which makes us so good at seeing evidence to support our views, also leads us to ignore contrary evidence. Motivated reasoning, which lets us quickly pull together the arguments and views that support what we already believe, makes us impervious to changing our minds. And groups where everyone agrees are known to become more extreme in their views after “deliberating”–this is the problem with much of the blogosphere.

Actually, I’m constantly asking myself when I’m writing one of these logorrheic gems of analytic brilliance if I really am being analytically brilliant or am I being selectively analytically brilliant in order to bolster my pre-existing beliefs and values? In other words, am I doing from the other viewpoint the same things that anti-vaccine zealots, for example, do when they cherry pick and misrepresent studies in order to support their beliefs that vaccines cause autism? Of course, that’s where our readers come in, as does the fact that I (and, I have no doubt, every other SBM blogger) frequently ask myself that very question. As Richard Feynman famously said, “The first principle is that you must not fool yourself – and you are the easiest person to fool.” Science is simply a method for minimizing the chance that you will fool yourself. To say “I saw it with my own eyes” is not enough, but that is what our brains are hard-wired to believe.

That’s one reason why I’m far less concerned about winning over committed ideologues. Although such a task is possible and people do change their minds, sometimes even about things very important to them, for the most part expecting to win over someone like J.B. Handley, Jenny McCarthy, or Barbara Loe Fisher is a fool’s errand. The people who need to be educated are the ones who are either on the fence or otherwise susceptible to pseudoskeptical, sophisticated-sounding arguments from denialists because they do not understand science or the issues. Although it will by no means be easy, such a goal is at least achievable.

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Cabling a SoftLayer Server Rack

A few weeks ago, SamF posted “Before They Were SoftLayer Data Centers,” a virtual scrapbook from the San Jose data center construction process, and based on the surge of traffic we saw to the post, our customers loved it. It’s incredible to see an open warehouse-looking space transformed into an enterprise data center environment, and there’s more amazingness where that came from.

In addition to the pre-”Truck Day” pictures we posted on the blog and in the San Jose DC Construction album on Flickr, we trained a video camera on a row in the data center to capture the cabling process.

What’s so interesting about plugging in cables?

Consider the fact that each of the network switches we use in a rack has at least 48 ports. Now consider that each rack has two public network switches, two private network switches and one out-of-band management network switch that need to be connected to every SoftLayer server in the rack. That’s 240 pre-measured network cables that need to be labeled and routed to specific heights in each rack … without getting tangled and knotted up (see: behind your TV or under your computer desk).

The cabling process is so precise that if a single cable is out of place, the zip-tie on an entire bundle will be cut, and the process is started from scratch. The process is time-consuming, but the results speak for themselves:

SoftLayer Server Rack

Without further ado, here’s the SJ data center team in action. The video is playing at 20x normal speed, and given the amount of time it takes to complete the cabling process for each rack, we enlisted the help of Spongebob SquarePants in our use of the “Two Hours Later” cut:

Impressed? Amazed?

Just wait until you see the time-lapse from Truck Day.

-Kevin

Giving Customers More Than They Expect

Giving a customer the ability to do something that they didn’t know they could (or even know was possible) can make for an exceptional customer experience.

I’ve had a season mini-pack of Dallas Mavericks tickets for a handful of years now and have always gotten the exact experience that I expected: The same seats every time, consistent food and drink, great entertainment, and a quality team on the court that wins considerably more often than not.

However, this year it’s been a little different. This year, they have thrown in several perks that cost them nothing or next to nothing but have made a huge difference in the overall experience.

One game in particular sticks out in my mind. A couple of weeks before a game against the Wizards, I got an email about a no cost chance for me and one other person to stand in a high five line to give fives to the players as they came out for warmups. I had no idea fans actually got to do this, so I gladly signed up and took my 5 year-old son to the game. I had also received an invite from the sales rep to choose a date to spend the first half of a game in one of the suites, so I made it the same night.

That night, we joined a small group of people down by the tunnel before the game, and we got to give all the players, Mark Cuban, the Mavs Maniacs and even a few security guards high fives. My son was over-the-moon to “meet” his favorite players – Dirk, Kidd, and Jet – could hardly contain himself.

This game also happened to be the week before the Super Bowl. I only mention it because on the way to our suite, I was blinded by the biggest ring I had ever seen. It turned out to be a Super Bowl ring and the guy wearing it was James Harrison (the linebacker for Steelers that lost a bunch of money to fines for helmet to helmet hits last season), so I got to meet him and wish him luck for the big game.

Oh, and and I can’t forget to mention the free hats, shirts, and Roddy B. bobblehead.

Long story short, I probably couldn’t tell you who won the other ten games I went to this year, but I don’t think I’ll forget anything about this particular game.

The thing I took away from this experience is when you give a customer something above and beyond what is expected, however seemingly insignificant, you can monumentally improve their customer experience.

To bring it back around to SoftLayer, we give customers a great API – a REST API at that. We give them VPN, a private network, IPv6, and a fully provisioned server in a couple of hours. Each of these differentiators enables us to provide products and services that our competitors can only hope to imitate.

The first time the customer uses the API to automatically create a new Cloud Instance from their own program, it’ll be a Maverick-game experience. When they transfer data from Washington, D.C., to San Jose, CA, on our private network with zero bandwidth charge, they’ll feel like they’re high-fiving Dirk Nowitski. When they access their server over the free KVM over IP, they’re walking up to the suite and meeting a Super Bowl champion. And all of that is on top of a stable, speedy server environment!

What can we do to improve your customer experience?

-Brad

3 Bars | 3 Questions: Community Development

I’ve been on the hook for a 3 Bars | 3 Questions interview for a few weeks now, and I finally found a few minutes to chat with Kevin about what’s going on in the world of SoftLayer Community Development. In the past two months, we’ve cranked everything up to 11 with the unveiling of our Technology Incubator Program and the Technology Partners Marketplace. Needless to say, we had a lot to talk about:

Over the past few weeks, we’ve posted video interviews and guest blogs from a few of our featured Technology Partner Marketplace participants, and you can expect to see more where that came from as we sign on new partners with killer applications and services that we can share with our customers. If you want to be one of those new partners, fill out our quick application, and we’ll get the ball rolling!

I’m looking forward to the next installment of “3 Bars | 3 Questions” because “The Mitch” – the man, the myth, the legend – will be in the hot seat.

The Mitch

-@teknowlogist

SoftLayer’s Android Client Gets an Extreme Makeover

One of the things you expect when you merge two organizations in the same vertical space is for your talent pool to get deeper. SoftLayer had a seriously talented bunch of developers before the merger – I should know, I consider myself one of them – and as I was promised would be the case, after the merger, we were joined by an equally talented group of engineers from The Planet. Where we had two low-level developers, now we have four. Where we had a dozen guys with .NET experience, now we have twenty. It’s better for us employees, and better for our customers too.

What I didn’t expect as part of the merger was that our talent pool would get wider. No, I don’t mean we now employ an army of body builders and Siamese twins. I mean as result of the merger, we ended up with an entirely new group of folks here unlike any SL previously had on the payroll. This new and exotic breed of folks – new and exotic at least from my perspective – are collectively known as “user experience” engineers.

I admit (and I suspect most software engineers will concur) when I develop something, it becomes my baby. Each software engineer has his or her own method for inciting that spark of genius … I start out with some ideas on a yellow pad, refine them until I can whip up an actual spec, code some unit tests and wait to see if my baby takes its first step or falls flat on its digital face. Either way, over time with gentle nudging and TLC, eventually an application grows. And like any loving parent I’m certain that my application can do no wrong.

So when I was told a “usability study” would be done on one of my babies by the user experience, team you can imagine what went through my mind. After all, I was there when the first API call succeeded. I was the one who got up in the middle of the night when the application got cranky and decided to throw an unhandled exception. Who the heck are these user interface specialist and what do they know that I don’t?

In retrospect, I couldn’t have been more wrong. I am a professional coder with more than a decade of experience under my belt. But I’m often more interested in how I can squeeze a few more CPU cycles out of a sub-routine than how much easier it would be for the user if I rearranged the order of the GUI’s a little bit. The user interface review I received really got me thinking from a user’s perspective and excited about the application in a way I hadn’t been since the early days when I banged out those first few lines of code.

Two weeks ago, we released a new, radically different looking Android client. If you are a current user of the application, you’ve undoubtedly received an OTA update by now, and I hope you are as pleasantly surprised by the result as I am. For those of you with Android phones who have not installed the SoftLayer client, I encourage you to do so. You can get more info by visiting http://www.softlayer.com/resources/mobile-apps/.

Before I let you go, what kind of father would I be if I didn’t take out my wallet and bore you to tears with pictures of my children? Without further ado, I present to you the latest and greatest Android Mobile Client:

SL Android App

SL Android App

SL Android App

SL Android App

-William

BLESSED JOHN PAUL II. Used the arts and media for spiritual enlightenment. – Inquirer.net


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BLESSED JOHN PAUL II. Used the arts and media for spiritual enlightenment.
Inquirer.net
It inspired us to learn more about Pope John Paul II, and to spread the word about his key initiatives and missions, like the use of the arts and media for spiritual enlightenment, his deep love for Jesus and Mary, the importance of inflaming the youth ...
Catholic education: Just the beginningThe Journal News | LoHud.com

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