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Some Flu Vaccine Updates

Posted on October 17, 2010 by Danzig

It is always flu season somewhere in the world. As Australia’s flu season comes to a close, we are getting ready for ours in the Northern Hemisphere. This is a good time to start thinking about getting the flu vaccine, and as always there is a lot of flu vaccine news to sort through.

Mark Crislip has already reviewed the evidence for the efficacy of the seasonal flu vaccine. Like most questions in medicine, the evidence is deceptively complex, and Mark does an excellent job of sorting through it, so I won’t repeat it here.

This year the H1N1 pandemic flu virus will be incorporated into the seasonal flu vaccine, so there will not be two separate vaccines as there was last year. H1N1 remains the dominant strain of seasonal flu, and as predicted the pandemic has simply been incorporated into the seasonal flu pattern.

Here are some updates on flu vaccine news – first the good news:

Flu Vaccine Efficacy

Two recent studies demonstrate the efficacy of the flu vaccine in improving outcomes. Mark Crislip discussed two weeks ago a recent study that shows that the flu vaccine (but not the pneumococcal vaccine) is associated with a decreased risk of heart attack. This makes sense as getting the flu can be a significant physiological strain and can plausibly provoke a heart attacks in those who are susceptible. This study emphasizes the importance of getting the seasonal flu vaccine early in the flu season.

Another recent study looked at the effect of maternal flu vaccination while pregnant and the subsequent risk of flu for their infant children. Angelia Eick et al studied 1169 mother-infant pairs among Navajo and White Mountain Apache Indian reservations and found that getting the seasonal flu vaccine while pregnant was associated with increase anti-flu antibodies up to 2-3 months old and a 41% reduction in the risk of flu in the first 6 months. This is important because young infants are generally not given the flu vaccine – they depend upon passive antibodies from the mother.

These two studies add to the body of evidence that clearly demonstrates that the flu vaccine is effective in preventing the flu and reducing morbidity. The media, however, also like to report about every flu vaccine side effect scare, whether legitimate or not.

H1N1 Vaccine and Narcolepsy

Over the summer it was reported that there were a cluster of cases of narcolepsy in Finland and Sweden. Narcolepsy is a sleep disorder characterized by excessive sleepiness. It is caused by a combination of genetics and environment, and can be triggered by infections with high fever. The appearance of narcolepsy in about a dozen children and adults was thought to perhaps be associated with the Pandemrix flu vaccine, and Finland promptly suspended use of this brand of flu vaccine. The possible association was widely reported – but the follow up investigation was not.

Sweden’s Medical Products Agency (MPA) investigated a possible association between narcolepsy and the flu vaccine, specifically Pandemrix, and found no association.

The agency’s report said six narcolepsy cases in Stockholm were in children, two of whom had not received the Pandemrix vaccine, according to the YLE report. Of 10 narcolepsy cases reported in adults, half had received the vaccine.

The CDC did their own review of the vaccine adverse events reporting system (VAERS) and found no pattern of reports that would be concerning for a link between vaccines and narcolepsy.

It is perfectly reasonable, as part of the precautionary principle, to take apparent clusters of diseases and investigate them to see if they are real or are just statistical clusterings (as Carl Sagan said – “randomness is clumpy”). It is also reasonable, and this happens often, to suspend use of a drug or medical product until a potential risk can be investigated. So there really was nothing unusual about the narcolepsy episode. Most apparent clusters like this turn out not to be real, and so it is no surprise that this was the case with narcolepsy.

The more difficult problem is the media response to these episodes. I would not say that such cases should not be reported, but rather that special care should be taken to put such reports into a reasonable context and to not prematurely and unnecessarily fear-monger. Further, when later investigations find that there was no risk, that should be given equal reporting – perhaps even more, as it is more difficult to quell fears than to stoke them. In addition, there is a subculture that is anti-science-based medicine, and also anti-vaccine. Such episode are exploited for propaganda purposes. It is likely that narcolepsy will now be added to the list of fears used against vaccines by such groups.

Flu Vaccine and Convulsions in Australia

Recently in Australia there has been a real cluster of fever and seizures in children who had received a particular brand of flu vaccine, the Fluvax. New Scientist reports:

Last week the Australian Department of Health and Ageing reported that flu vaccination was “causally related” to fever and convulsions in 99 Australian children this year. Of those, 74 had no other possible cause, and Fluvax had been given to all 66 of those where the vaccine’s name was known, CSL says it is trying to identify the problem.

Unlike the narcolepsy episode, this appears to be a real cluster, and the association with a particular brand of flu vaccine statistically solid. Fever with flu vaccine is a known risk, and in young children a high fever can sometimes trigger what is called a febrile seizure. Febrile seizures, while scary for the parents, are most often benign and to not result in any permanent damage or long term seizure risk. Rarely, however, there are neurological complications.

The baseline risk of febrile seizures from the flu vaccine is about 1.4 per 10,000 doses. This is much less than what would be expected from the flu itself, and so getting the vaccine actually decreases the risk of developing febrile seizures. The Fluvax, however, was associated with a 50 fold increase in risk of febrile seizures from that normally associated with the flu vaccine. Even with this increased risk there was still more statistical benefit than risk from this vaccine, especially since the H1N1 flu (which is included in this year’s seasonal vaccine) had such a high mortality rate (1% of those children admitted to the hospital with confirmed H1N1 flu in Australia died.

But of course this is an unacceptable side effect from the Fluvax, and since it is dramatically greater than other brands there must be something wrong with this particular batch. It is not yet known what that is. This is precisely the reason for careful post-marketing surveillance of drugs and vaccines – if unexpected side effects emerge then steps can be taken to quickly remove the offending agent from the market until the risks can be sorted out.

The same company that makes Fluvax, CSL, also makes a product for the Northern Hemisphere called Afluria. The CDC is recommending that this brand not be given to children under 5 years old, as other brands are also available. It is not known if Afluria carries the same increased risk as Fluvax, but again this is a reasonable application of the precautionary principle.

Conclusion

This latest evidence supports what is already known about the seasonal flu vaccine – it works, but it is not without risk. All medical interventions have risk and it is important to always consider risk vs benefit. When considered in this context, the evidence clearly shows that the benefit of receiving the flu vaccine far outweighs the small risk. The flu is a serious illness and preventing it carries significant benefit.

Skepticamp: Invading the Great White North on October 23

Posted on October 17, 2010 by Danzig

skepticamp

Are you frustrated by the prevalence of pseudoscience in medicine? Are you interested in critical thinking and science? Is SBM your rational refuge? Want to meet like-minded science advocates? On October 23, 2010 four Skepticamps will take place across Canada. If you enjoy reading this blog, you’ll probably enjoy Skepticamp.

Happily, Skepticamp involves no actual camping. It’s a flexibly organized, collaborative conference on science and critical thinking. Skepticamp is not your typical medical conference with high fees, bad PowerPoint, long talks and little interaction with speakers. Skepticamps are open, collaborative, interactive, and FREE.

Here are the four events, and a few of the SBM-related highlights.

Vancouver: ear candling; dopamine as an explanatory model for superstition; and SBM copy editor Paul Ingraham speaking about his first year as an alternative medicine apostate.
Winnipeg: fad diets and detoxes; homeopathy; and the continued relevance of vaccinations
Ottawa: self-help cults; genes and inherited diseases; science denial; and forensic science
Toronto: I’ll be speaking about natural health product regulation. Other talks include a guide to the medical literature; the cognitive underpinnings of sympathetic magic; and naturopathy.

If there’s one near you, consider attending Skepticamp on October 23. Given it’s free, Skepticamp offers tremendous value-for-money. We invite our American colleagues to grab their passports, make a break for the border, and keep driving until there are Tim Hortons everywhere. And if you’re attending the Toronto Skepticamp, be sure to say hello.

Mayo Clinic on Home Remedies

Posted on October 17, 2010 by Danzig

I write a lot of critical articles. It’s nice to be able to write a positive one for a change. I received a prepublication proof of The Mayo Clinic Book of Home Remedies: What to Do for the Most Common Health Problems. It is due to be released on October 26 and can be pre-ordered from Amazon.com. Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic. I was expecting some questionable recommendations for complementary & alternative medicine (CAM) treatments, but I found nothing in the book that I could seriously object to.

It is organized alphabetically, starting with acne and airplane ear and progressing through bedbugs, boils and bronchitis, dandruff, depression and diabetes to warts, wrinkles and wrist pain. Each entry consists of (1) a description of the problem and its symptoms, (2) treatments you can try at home, and (3) when to seek professional medical help. It concludes with a short section on emergency medicine that covers anaphylaxis, bleeding, burns, CPR, choking, fracture, heart attack, poisoning, seizure, shock and stroke.

Nowhere does it mention acupuncture, chiropractic, energy medicine, or homeopathy. It gives good, clear guidance about when a health problem should not be treated with home remedies. Its recommendations about diet and exercise are solid. It doesn’t recommend anything that can’t be supported by published studies and common sense. When it recommends herbal remedies and diet supplements, it is cautious about what it claims. For instance, glucosamine and chondroitin are listed for osteoarthritis, but they point out that further study is required and they say “because the supplements may help and appear to be safe, it may not hurt to give them a try.” Not exactly a strong recommendation!

For elevated cholesterol, it recommends weight loss, diet, exercise, limiting alcohol, avoiding tobacco; and then it says “Experiment with natural products. Although few natural products have been proven to reduce cholesterol, some may be helpful. You could consider…” artichoke, barley, psyllium, flaxseed, garlic, oat bran, and plant sterols. I can’t really argue with that, especially if the patient is monitored by a doctor (which of course would be required to get blood tests that would tell if the natural products have had any effect).

For gout, they recommend against megadoses of vitamin C and their mention of cherries is fair and balanced:

Studies show an association between cherries and lower levels of uric acid in your blood, but it isn’t clear if the cherries have any effect on the signs and symptoms. Eating cherries and other dark-colored fruits, such as blackberries, blueberries, purple grapes and raspberries, may be a safe way to supplement gout treatment, but discuss this strategy with your doctor first.

It includes appropriate warnings. For instance, in the article on bladder infections, it says that for prevention you can try cranberry juice (“though still not proven in rigorous study”), but don’t try it if you’re taking Coumadin, since it may lead to bleeding. In the cholesterol section, it warns against red yeast rice because it contains lovastatin and there is no way to determine the quantity or quality of the drug.

The book recommends a few things that a rigorous scientist might hesitate to recommend because of insufficient evidence. But unlike many less trustworthy sources of medical advice, this book will not tell a patient to try anything that might be dangerous, anything that has been tested and found not to work, anything that is based on belief rather than on evidence, or anything that might delay or interfere with needed medical treatment. It is safe, sensible, and woo-free.

It isn’t perfect, but it’s pretty good. I would feel comfortable recommending it to a layman who wanted to know “what home remedies can I try?” or who wanted a home reference book about what can be done instead of calling the doctor and when calling the doctor is the more prudent course.

I’m not worthy! I’m not worthy! (For the Lorne Trottier Public Science Symposium)

Posted on October 17, 2010 by Danzig

In two weeks, yours truly will be participating in the 2010 Lorne Trottier Public Science Symposium at McGill University in Montreal. This year, the theme is Confronting Pseudoscience: A Call to Action. I’ll be speaking with Ben Goldacre and Michael Shermer on Monday, October 18 from 5 to 7 PM on the Threat of Pseudoscience. On Tuesday, October 19, the ever-amazing Randi will speak on investigating paranormal claims. Unfortunately, the organizers couldn’t get Randi on the same stage with us because he couldn’t make it to Montreal from TAM London in time for Monday night; so this is the next best thing. Randi deserves the stage to himself anyway.

Obviously, I can’t wait, although I must admit that I’m rather nervous. To share the stage with Michael Shermer and Ben Goldacre and to get to hang out with them plus Randi, well, that’s more than I could have hoped for or imagined. It leaves me feeling like Wayne in this clip, with Shermer, Goldacre, and Randi as Alice Cooper (very appropriate, given Randi’s history of having done the effects for Alice Cooper’s stage show back in the 1970s):

So, if you happen to be in the Montreal area or can get there on October 18 and/or 19, come on over to McGill. It’ll be a rousing good skeptical time. I don’t yet know what Ben Goldacre and Michael Shermer will be discussing, but I’ll be speaking about cancer quackery (although I probably won’t be able to resist a brief commentary on quackademic medicine). I’ll also be on Dr. Joe’s radio show on CJAD 1010.

The Guatemala syphilis experiment and medical ethics in science-based medicine

Posted on October 17, 2010 by Danzig

Several of the bloggers here at SBM have repeatedly criticized various clinical trials for so-called “complementary and alternative medicine” interventions for various conditions and diseases (or should I say dis-eases?) for being completely unethical. Examples include the misbegotten clinical trial for the Gonzalez protocol for pancreatic cancer, which — surprise, surprise! — ended up showing that patients undergoing Dr. Gonzalez’s combination of 150 supplements a day, dietary manipulations, and coffee enemas, actually did much worse than those undergoing standard of care, despite how depressingly poor the results of standard of care are; clinical trials of homeopathy in Honduras and other Third World countries, which both Wally Sampson and I lambasted; and ongoing clinical trial of chelation therapy for cardiovascular disease. I’ve also criticized the “autism biomed” movement, that amalgamation of parents who believe that vaccines cause autism and yet are willing to subject their children to all sorts of quackery to “cure” the “vaccine injury” of uncontrolled and unethical experimentation on autistic children. As valid as all these criticisms are, it is important to recognize that science-based medicine is not free of its own abuse of ethics.

A couple of weeks ago, I wrote about the concept of clinical equipoise. Clinical equipoise is a critical concept in any clinical trial. Basically, a state of clinical equipoise exists when there is genuine scientific uncertainty over which of the options being tested in/on living, breathing human beings is better, and any clinical trial in which a state of clinical equipoise does not exist is at the very least ethically dodgy and probably downright unethical. For example, when the occasional anti-vaccine activist argues for a randomized controlled clinical trial comparing vaccinated children and unvaccinated children, it’s easy to shoot that idea down as unethical because there is no clinical equipoise. The children receiving placebo vaccines would be put at a much higher risk of suffering harm compared to the vaccinated children because they would be left unprotected against life-threatening diseases. In the realm of conventional medicine, the reason that few cancer clinical trials involve a placebo control group anymore but instead test a new therapy either against the standard of care or with the standard of care is because in many, if not nearly all, cases placebo use in a cancer patient is unethical when there exists effective therapy, even if the therapy is not all that effective. What all this boils down to is that science is only part of the basis of science-based medicine. Medical ethics must take precedence. After all, arguably the most efficacious way to test a new antibiotic would be to infect people with the bacteria the antibiotic treats and then divide these people up into a placebo control group and a group receiving the antibiotics to see how each group does. After all, this is the sort of thing that the Nazis and Japanese did during World War II, and the same sort of dehumanization and abuse of research subjects that every ethical precept regarding human subjects research that has been developed since then, such as the Helsinki Declaration of 1964, has been designed to prevent.

Unfortunately, medical scientists in the U.S. have not always lived up to these precepts. The most famous example is arguably the Tuskegee syphilis experiment, in which poor black men with syphilis were studied and the control group denied effective therapy for syphilis even after it was known that penicillin was an effective treatment for syphilis. This study spanned 40 years, from 1932 to 1972, and is justifiably held up as one of the worst examples of research misconduct in American history, if not the history of the world. The shock the revelation of this study to the American public in 1972, when it learned of men dying of syphilis, women contracting syphilis, and babies being born with congenital syphilis, all unnecessarily, led to Belmont Report and the establishment of the Office for Human Research Protections (OHRP).

It turns out that there was an even worse atrocity against medical science perpetrated by U.S. investigators in Guatemala over 60 years ago that only now has come to light in stories in the New York Times, MSNBC, and elsewhere. So bad was the offense that Secretary of State Hillary Clinton and Secretary of Health and Human Services Kathleen Sebelius have issued a formal apology to the Guatemalan government for the experiments in which Guatemalan prisoners were intentionally infected with syphilis and then treated with antibiotics, an apology that President Obama reiterated in a personal telephone call to Guatemalan President Alvaro Colom on Friday.

Experimenting on Guatemalans

The Guatemala syphilis experiment might have remained lost in the depths of history, unknown, records of its having taken place buried in archives at the University of Pittsburgh, were it not for the efforts of Wellesley College Professor of Women’s Studies Susan Reverby and medical historian, who unearthed the notes of John C. Cutler, who, ironically enough, later spent some time as an important member of the team carrying out the Tuskegee experiment and continued to defend the study 20 years after it was closed. What she found was horrifying, and she has recently published a manuscript describing her findings. Because I always like to go to the primary source wherever possible, I will refer you to the manuscript, available on Dr. Reverby’s faculty web page and entitled “Normal Exposure” and Inoculation Syphilis: A PHS “Tuskegee” Doctor in Guatemala, 1946-48 (synopsis here). The HHS response can be found here, including the statement issued on Friday by Clinton and Sebelius in both English and Spanish.

The background behind Professor Reverby’s revelations is important. As she states in the advanced synopsis:

Perhaps the most infamous of American research studies is the “Tuskegee” Syphilis Study in which the U.S. Public Health Service (PHS) watched, but did not treat, hundreds of African American men with late stage syphilis for forty years (1932-1972).1 Much of the folklore surrounding this study assumes that the doctors actually infected African American men in Macon County, Alabama with syphilis by inoculating them with the disease. Historians of the Study, the author included, have spent years now explaining why this was not true and why this myth persists. Part of the explanation is that the spirochete-shaped bacteria that cause syphilis cannot be cultured and grown in a laboratory, easily put into a syringe, or transferred from the blood of one infected person to another.
The inoculation story that is part of the Tuskegee myths did, however, go on elsewhere. In 1946-48, Dr. John C. Cutler, a PHS physician who would later be part of the Syphilis Study in Alabama in the 1960s and continue to defend it two decades after it ended in the 1990s, was running a syphilis inoculation project in Guatemala, co-sponsored by the PHS, the National Institutes of Health, the Pan American Health Sanitary Bureau (now the Pan American Health Organization), and the Guatemalan government.
It was the early days of penicillin and the PHS was deeply interested in whether penicillin could be used to prevent, not just cure, early syphilis infection, whether better blood tests for the disease could be established, what dosages of penicillin actually cured infection, and to understand the process of re-infection after cures. Many scientific questions remained to be answered.

Now you see why the Guatemala syphilis experiment is arguably worse than the Tuskegee experiment, although the Guatemalan experiment only lasted two years and every man infected with syphilis was given penicillin. On the other hand, as the full manuscript describes, although researchers did obtain permission for their studies from the prisons and other institutions with which they worked, they did not receive permission from the inmates or their families. Indeed, deception was part and parcel of the entire process. In return for cooperation, researchers offered supplies to the institution, such as anti-seizure medications like Dilantin, refrigerators to store medications, and a “motion picture projector that supplied the sole recreation for the inmates, metal cups, plates and forks to supplement the completely inadequate supply available.” Individual subjects were plied with cigarettes, “an entire packet for inoculation, blood draws or spinal taps and a single cigarette for ‘clinical observation.’”

Researchers also went to ludicrous extremes to infect the men with syphilis. First, they took advantage of legalized prostitution in Guatemala and the fact that Guatemala allowed prostitutes to pay regular visits to men in penal institutions by locating prostitutes with syphilis:

With the cooperation of officials at the Ministry of Justice and the warden of Guatemala City’s Central Penitentiary, which housed nearly 1500 inmates, prostitutes who tested positive for either syphilis or gonorrhea were allowed to offer their services to prison inmates, paid for by U.S. taxpayers through the funds of the PHS. In yet another set of experiments, uninfected prostitutes had inoculum of the diseases placed on their cervixes before the sexual visits began. Serological tests were done on the inmates before the prostitutes were invited to the prison and then afterwards to see if infection had occurred. The men were divided into groups and various chemical and biological prophylaxis techniques were tested after presumed infection. If positive, the men were then provided with enough penicillin to produce a cure.

Your tax dollars at work in 1946. This method soon ran into problems:

Not enough of the sexually well-serviced men (the researchers actually timed how long they spent with the prostitutes and thought they acted “like rabbits”), even when plied with alcohol, seemed to getting syphilis. The prostitutes were not easily controlled either, and one researcher lamented, “unfortunately our female donor is leaving her profession for marriage and is no longer available.”

Due to the unreliability of the serological tests used to diagnose syphilis in the 1940s, the researchers soon went beyond these methods. It turned out that there were too many positive blood tests even before the men were exposed to syphilis, which posed a huge problem given that the research protocol required men who had never had syphilis or who’d had it and been cured. This led to a trial examining the serum of children in an orphanage, where they found that indeed the false positive rate of the serological test for syphilis was quite high. This problem also meant that the researchers couldn’t yet answer whether penicillin could prevent syphilis.

So Cutler and his team went beyond using prostitutes and isolated syphilis to directly inoculate inmates with. Their sources were the gumma (syphilitic growths) on the testicles of infected rabbits or scraping the penile chancres of infected men, from which they had to isolate the spirochete that causes syphilis. This was difficult, because the spirochete could not survive more than 45 to 90 minutes outside the body, during which time it had to be isolated, centrifuged with fresh home-made beef heart broth, and then delivered to the subjects:

With the men, the inoculation was often much more direct after what soldiers for generations had called the “short arm” inspection. They chose men with “at least moderately long foreskins [to keep the mucus membranes moist]” and who could “sit or stand calmly in one spot for several hours.” In the experiments, a doctor held the subject’s penis, pulled back the foreskin, abraded the penis slightly just short of drawing blood by scraping the skin with a hypodermic needle, introduced a cotton pledget (or small dressing) and dripped drops of the syphilitic emulsion onto the pad and through it to the roughed skin on the man’s penis for at least an hour, sometimes two.

This was also compared with other methods of introducing the spirochete, including scraping of the forearm, ingestion of syphilitic tissue mixed with distilled water, introduction into the spinal fluid, and direct injection into the bloodstream.

It turns out that even back in 1946 many of the officials who knew of or participated in the experiment knew it was unethical. Even Cutler was reported to have said, “As you can imagine, we are holding our breath, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at times.” Even more disturbing is the general attitude among several researchers seemed to view law breaking as sometimes necessary for the advancement of medical science, as Thomas Rivers, who led the Rockefeller Institute for Medical Research Hospital in New York, made clear in his memoir in 1967:

Well, all I can say is, it’s against the law to do many things, but the law winks when a reputable man wants to do a scientific experiment. For example, the criminal code of the City of New York holds that is a felony to inject a person with infectious material. Well, I tested out live yellow fever vaccine right on my ward in the Rockefeller Hospital. It was no secret, and I assure you that the people in the New York City Department of Health knew it was being done….Unless the law winks occasionally, you have no progress in medicine.

It is against this attitude that ethical standards and laws have evolved. It is also as a result of these abuses that many minorities and underprivileged groups of people are mistrustful of physicians and science. Supporters of SBM can’t deny that there have been serious ethical violations committed by overzealous scientists who came to value the study of their scientific question more than they did for the rights and dignity of their human subjects, because the evidence of such violations of human rights are incontrovertible. The questions remain: What to do about them and how to prevent them?

The Belmont Report, The Common Rule, and CAM

After the horrors of Nazi medical experimentation and the abuses during the Tuskegee syphilis study (remember, the Guatemala syphilis experiment was not widely known until now), it was clear that rules were needed to protect human research subjects from such abuses. First came the Nuremberg Code in 1947. This code, drafted in the wake of the infamous Doctors’ Trial at Nuremberg set forth ten principles to govern human subjects experimentation, many of which regular readers of SBM will be familiar with. Examples include the requirement for informed consent; that unnecessary pain and suffering be avoided; that the experiment should be designed based on the results of animal experimentation and knowledge of the natural history of the disease that justifies the performance of the experiment (prior plausibility, anyone?); the requirement that subjects can refuse to continue at any time; and that no experiment should be conducted where injury, disability, or death can reasonably be expected (clinical equipoise). The Declaration of Helsinki, introduced in 1964 by the World Medical Assembly, is based on the same principles as the Nuremberg Code but takes them even further, for example, stating that “the interest of science and society should never take precedence over considerations related to the well-being of the subject.” The Helsinki Declaration was last updated in 2008. It is ironic that at the time the Nuremberg Code was being written and approved that the U.S. government was engaging in the same sort of abuse of human research subjects that the Nuremberg Code was designed to combat.

In the U.S., the Nuremberg Code and the Helsinki Declaration notwithstanding, the Tuskegee debacle was the impetus that led to the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research finalized on April 18, 1979. This report identifies three essential and fundamental ethical principles for human subject research (respect for persons, beneficence, and justice) that form the basis of all Department of Health and Human Services human subject protection regulations to this day. It is essential reading for anyone doing human subject research in this country. In 1991, these regulations were — finally! — codified into what is now known as The Common Rule. All institutions doing federally funded research are required to adhere to The Common Rule.

A key aspect of The Common Rule is the Institutional Review Board (IRB). The IRB is in essence a committee that oversees all human subject research for an institution and makes sure that the studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that (1) the risks are minimized and that the risk:benefit ratio is very favorable; (2) to minimize any pain or suffering that might come about because of the experimental therapy; and (3) to make sure that researchers obtain truly informed consent. I’ve written extensively about The Common Rule before in the context of how certain CAM trials violate the Common Rule and how, for example, Mark and David Geier created a sham IRB packed with their cronies (as so ably documented by Kathleen Seidel) to rubber-stamp their unethical studies of using Lupron to treat the “vaccine injury” they believe to be the cause of autism. What is important (and embarrassing for proponents of SBM) to note is that The Common Rule only first went into effect in 1981 and reached its current form in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. What that means is that, in the United States at least, the current government regulations mandating a baseline standard of ethics have only been in effect less than 30 years and only in their current form for less than 20 years.

Ethics: The difference between CAM and SBM

Not surprisingly, CAM proponents have jumped all over these revelations. For example, even quackery promoter Mike Adams has a grain of a valid point when he writes hysterical headlines like Guatemalan STD medical experiments were just one crime in a long history of medical-government collusion to use humans as guinea pigs. Unfortunately for him, he can’t resist taking a valid criticism and running right off the rails with it. Most of the examples he mentions date back at least 50 years and are now commonly known. Few of them are more recent than the 1970s. Most of these are either problems that couldn’t reasonably been foreseen (for instance, the observation that 30% of the participants of a trial for a vaccine against hepatitis B were found to be HIV-positive in 1983) or that are questionable pseudoscience at best, such as ranting against the clinical trials of Gardasil or labeling vaccine mandates as being the equivalent to the Tuskegee or Guatemala syphilis experiments. This is a point that Anne Dachel, Media Editor for the anti-vaccine propaganda blog Age of Autism, predictably parroted yesterday in a post entitled Valid Concern for 60 Year Old Medical Travesty: What About Today’s?, in which she attacks bioethicist Art Caplan for alleged hypocrisy in his refutations of anti-vaccine misinformation in “contrast” to his justifiable outrage over the revelation of the Guatemala syphilis experiment, even going so far as to write:

Increasing exposure to mercury is having a dramatic impact on our lives. “Nonetheless, officials knew it was wrong” also means that there’s a great incentive to cover up the damage at all costs. There is a real lesson from the Guatemala and Tuskegee experiments. Let’s hope it doesn’t take 60 years before officials admit what mercury exposure in vaccine has done to our children.

Never mind that the concept that mercury in vaccines causes autism is a long-discredited hypothesis, a failed hypothesis even more discredited (if that were possible) than the hypothesis that vaccines cause autism. The difference is important; in the case of vaccines science is on the side of those defending the clinical trials studying vaccines and their efficacy, not on the side of anti-vaccine activists like Anne Dachel. Odd, too, that she failed to mention Mark and David Geier’s and Andrew Wakefield’s completely unethical experiments.

Not really, actually.

Yes, charges of hypocrisy go both ways, which is why one of the reasons I wanted to write about the Guatemala syphilis experiment is that it is a stark reminder to proponents of SBM (like myself) that SBM does have a history of not always being as ethically pure as we should be. Indeed, the U.S. Government was right, albeit late, to apologize to the Guatemalan government:

The sexually transmitted disease inoculation study conducted from 1946-1948 in Guatemala was clearly unethical. Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health. We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices. The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala. The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago.
Today, the regulations that govern U.S.-funded human medical research prohibit these kinds of appalling violations. The United States is unwavering in our commitment to ensure that all human medical studies conducted today meet exacting U.S. and international legal and ethical standards. In the spirit of this commitment to ethical research, we are launching a thorough investigation into the specifics of this case from 1946. In addition, through the Presidential Commission for the Study of Bioethical Issues, we are also convening a body of international experts to review and report on the most effective methods to ensure that all human medical research conducted around the globe today meets rigorous ethical standards.

Reparations to survivors and families would be entirely appropriate in a case like this, as is the investigation ordered by the U.S. government into what happened. It is also entirely appropriate to point out, as Robert Herriman does, that at the time Dr. Cutler’s experiments were being carried out, the U.S. government was passing judgment on the Nazi doctors who carried out the same sorts of experiments, such as purposely infecting prisoners with tetanus and other agents to test the effectiveness of the antibiotic, sulfonamide? What was done in Guatemala in the name of public health was, at its core, different only in that the U.S. didn’t actually round up prisoners and throw them in concentration camps to do its experiments. In other words, little different.

The difference, however, is that proponents of SBM must be (and, for the most part, are) advocates for ethics in all medical experimentation, be it animal or human research. SBM depends upon science and rigorous clinical trials, but never at the expense of violating clinical equipoise, subjecting subjects to risks without true informed consent, or violating patient autonomy. All too many CAM advocates and anti-vaccine advocates use ethical misadventures and abuses as nothing more than a tu quoque argument; they delight in pointing out the gross ethical violations that are committed from time to time by science-based investigators while ignoring those committed by “their side,” such as Nicholas Gonzalez and the investigators performing the Gonzalez trial, Mark and David Geier, Andrew Wakefield, and the investigators performing the TACT trial. (Ironically, except for the Geiers’ trial, all of these trials were funded by our tax dollars — every bit as much as the Guatemalan or Tuskegee syphilis trials.)

I have long argued that there should be no such thing as “alternative” medicine. Rather, there should be one scientific standard for medicine regardless of where it comes from, and that includes all of what is commonly referred to as “CAM.” Similarly, there should be one ethical standard for all research involving human subjects. Unlike Adams and Dachel, when I condemn ethical atrocities in CAM trials that does not mean I will turn a blind eye when such lapses occur in trials of ostensibly science-based medicine and nor should anyone else. The Guatemalan syphilis experiment was indeed a gross failure on the part of SBM to live up to ethical precepts and police its own, but, as shocking as this incident is, it does not validate Mike Adam’s quackery and conspiracy theories or Anne Dachel’s anti-vaccine pseudoscience any more than it invalidates science-based medicine. What it should do is to strengthen the resolve of anyone involved in SBM never to let something like this happen again, regardless of the kind of medical study.

Some Sunday afternoon reading…

Posted on October 17, 2010 by Danzig

…can be found here, at the Cancer Research Blog Carnival.

Chiropractic Vertebral Subluxations: Science vs. Pseudoscience

Posted on October 17, 2010 by Danzig

A 1997 publication by the Foundation for Chiropractic Education and Research, supporting the vertebral subluxation theory, noted that “…we [chiropractors] have successfully distanced the concept of a chiropractic subluxation from that of an orthopedic subluxation.”¹ When discussing “subluxations” or misaligned vertebrae, however, chiropractors often fail to point out the difference between an orthopedic subluxation and a chiropractic subluxation. Reference to subluxations in medical literature is often presented as support for the practice of chiropractic as a method of adjusting vertebral subluxations to “restore and maintain health.”

In the eyes of the public, the chiropractic vertebral subluxation theory has confused the definition of the word “subluxation,” a common medical term. Unlike the mysterious, undetectable and asymptomatic chiropractic “vertebral subluxation complex” alleged to be a cause of disease, a real vertebral subluxation, that is, an orthopedic subluxation, can be a cause of mechanical and neuromusculoskeletal symptoms but has never been associated with organic disease.

Subluxations: Real and Imaginary

An orthopedic subluxation, recognized and named as such since the days of Hippocrates, is a painful partial dislocation. Simple misalignment of a vertebra, also referred to as a “subluxation,” is commonly caused by disc degeneration, curvatures, spondylolysis, and structural abnormalities. Such a subluxation may or may not be mechanically symptomatic and can be seen on a plain x-ray image. In the absence of pathology such as disc herniation or osteophyte formation, these common vertebral subluxations or misalignments rarely affect spinal nerves and have never been associated with organic disease. Spinal nerves supply musculoskeletal structures. The body’s organs are supplied primarily by autonomic nerve ganglia and plexuses located outside the spinal column and by cranial and sacral nerves that pass through solid bony openings, providing overlapping nerve supply independent of any one spinal nerve that passes between two vertebrae.

An orthopedic subluxation, a true vertebral misalignment, or a mechanical joint dysfunction that affects mobility in the spine is not the same as a “chiropractic subluxation” that is alleged to cause disease by interfering with nerve supply to organs. Such a subluxation has never been proven to exist. There is no plausible theory and no credible evidence to support the contention that “nerve interference” originating in a single spinal segment can cause an organic disease.

Unable to provide evidence that commonly occurring vertebral misalignment can cause organic disease, advocates of the subluxation theory have reasoned that there must be some other type of joint dysfunction that can affect general health. They have chosen, by consensus, to call this undetectable lesion a “vertebral subluxation complex,” which “embraces the holistic nature of the human body, including health, well-being, and the doctor/patient relationship as well as the changes in nerve, muscle, connective, and vascular tissues which are understood to accompany the kinesiologic aberrations of spinal articulations.”¹

Some chiropractors claim to be able to locate these elusive subluxations by using surface electromyography, thermography, vibratory instruments, leg length checks, or by palpating the spine.

A largely ignored landmark review of the literature by a Ph.D. and a chiropractor (Nansel and Szlazak), published in 1995, concluded that there is not a single appropriately controlled study to indicate that any dysfunction in structures of the spinal column is a cause of organic disease.² The review noted that pain and other symptoms referred from a spinal segment can “create overt signs and symptoms that can mimic, or simulate (rather than cause), internal organ disease,” lending no support to the vertebral subluxation theory. Spinal nerves are commonly irritated or compressed, causing pain and other symptoms in the musculoskeletal structures supplied by the affected nerve. But even the most severe compression of a spinal nerve does not cause organic disease.

A review of the current evidence on the epidemiology of the subluxation construct (Mirtz, et al, 2009) also failed to find any credible evidence supporting the chiropractic vertebral subluxation theory. This paper, authored by three chiropractors and a Ph.D., concluded that “No supportive evidence is found for the chiropractic subluxation being associated with any disease process or of creating suboptimal health conditions requiring intervention. Regardless of popular appeal this leaves the subluxation construct in the realm of unsupported speculation. This lack of supportive evidence suggests the subluxation construct has no valid clinical applicability.”³

While there is justification for use of the word “subluxation” when referring to a mechanical-type spinal problem, there appears to be no justification whatsoever for suggesting that a “chiropractic subluxation” can affect general health.

A Chiropractic Subluxation by Any Other Name…

If the chiropractic profession dumped the subluxation theory and took the steps needed to become a physical-treatment specialty in the care of mechanical-type neck and back problems, it could remain open to future research that might reveal evidence that spinal manipulation benefits general health?a finding that would be a bonus for use of manual therapy. Until then, the theory that adjusting a “vertebral subluxation complex” will restore and maintain health is too implausible to warrant support by the scientific community.

Unfortunately, the chiropractic profession in the United States continues to be defined by subluxation theory. Too few chiropractors are willing to “step out of line” and announce that the theory (more accurately defined as a belief) is scientifically indefensible and should be dumped. Failure of chiropractic associations to publicly disagree with subluxationists who identify chiropractic as a method of adjusting the vertebral subluxation complex keeps chiropractic marginalized and subject to ridicule by the scientific community. Without some identifying label or degree that distinguishes science-based chiropractors from subluxation-based chiropractors, medical physicians will continue to be reluctant to refer a patient to a chiropractor, lest they deliver a patient into the hands of a pseudoscientific practitioner whose philosophy embraces an anti-medical approach and endangers the patient. Science-based chiropractors who are properly specialized should openly announce their limitations if they are to earn the recognition and trust of medical professionals who can provide the referrals needed to sustain a specialized practice.

In May of 2010, the British General Chiropractic Council (GCC) advised members of the British Chiropractic Association (BCA) that “The chiropractic Vertebral Subluxation Complex…is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns.”⁴ Chiropractors were advised to provide evidence-based care that “incorporates the best available evidence from research, the preferences of the patient and the expertise of practitioners including the individual chiropractor her/himself.”⁴ In response, the British Chiropractic Association advised its members to “refrain from making any reference to Vertebral Subluxation Complex in media to which their patients or the general public may have access,” adding that “this advice has no bearing on scope of practice.”⁴

While the action of the GCC and the BCA in avoiding reference to the Vertebral Subluxation Complex is an important and unprecedented move in the right direction, it appears that the door was left open for British chiropractors to continue treating a broad scope of health problems. Such leniency would not restrict use of a variety of unproven treatment methods (originally based on the vertebral subluxation theory) promoted by individual chiropractors and preferred by indoctrinated patients.

Although many chiropractors are now backing away from the chiropractic vertebral subluxation theory, many continue to use the theory to justify treating a broad scope of health problems by “adjusting” the spine. They simply point to legal and dictionary definitions of chiropractic to support their claims. Some who do not use the word “subluxation” simply substitute another word or words, such as “joint dysfunction,” in support of their belief that some kind of segmental spinal “lesion” can affect overall health.

Spinal Manipulation Stigmatized by Subluxation Theory

The basic definition of chiropractic provides opportunity for pseudoscientific spinal manipulators who treat a broad scope of health problems with a myriad of implausible and unproven treatment methods, alienating an informed public along with the scientific community.

According to a study published in 2005, the percentage of the US population seeing chiropractors annually for various reasons decreased from 9.9% in 1997 to 7.4% in 2002.⁵ Using data from a 2002 National Health Interview Survey, a study published in a 2010 issue of The Journal of the American Board of Family Medicine reported that about 6% of the US population used complementary alternative medicine (CAM) to treat their back pain. About 74% of this 6% (about 4.4% of the population) went to chiropractors; 22% went to massage therapists.⁶ Since conventional medical practitioners traditionally refer back-pain patients to physical therapists, physiatrists, or orthopedic surgeons, physician referral to CAM practitioners remains low.

The chiropractic profession would be well advised to make the changes needed for recognition as specialists in the care of mechanical-type back pain, “the second leading reason for ambulatory office visits” and the most common reason for use of CAM in the United States.⁶

Science-based chiropractors who do not subscribe to the chiropractic vertebral subluxation theory, who specialize in the use of manipulation and other physical treatment methods in the care of mechanical-type neck and back problems, will use manipulation more appropriately. Unfortunately, there is no recognized label, degree, or association that distinguishes such chiropractors from subluxation-based chiropractors. Without a clear choice in selecting a good chiropractor, few physicians will risk referring their patients to a chiropractor, making survival difficult for properly specialized chiropractors.

As Sir James Frazer wrote in 1922, “The ablest man is dragged down by the weakest and dullest, who necessarily sets the standard, since he cannot rise, while the other can fall.”⁷

Belief System Perpetuates Status Quo

Since my graduation from a chiropractic college in 1956, arguments and opinions about chiropractic have changed very little. No one seems to know what chiropractic is or what it does. No two chiropractors can agree on how to treat a specific ailment or which vertebrae to adjust. There are at least 97 named antithetical adjustive techniques,⁸ all based on a nonsensical, nonfalsifiable chiropractic vertebral subluxation theory. The chiropractic profession as a whole has yet to be properly defined and specialized so that diagnosis and treatment methods are uniformly consistent and interchangeable among chiropractors. Subluxation-based chiropractic continues to be at odds with mainstream health care.

Although the public generally thinks of a chiropractor as a “back doctor,” societal suspicion keeps utilization of chiropractic low. In a cycle perpetuated by the definition of chiropractic, science takes a back seat to standards that allow some chiropractors to follow a 19^th century philosophy formulated by a magnetic healer 115 years ago. So far, the chiropractic profession has failed to take a stand and draw a line that separates sense from nonsense in chiropractic care, keeping the profession on the fringe of health care and in the realm of alternative medicine. The Chiropractic Paradigm formulated by the Association of Chiropractic Colleges (ACC), representing North American Chiropractic Colleges, proposes that “Chiropractic is concerned with the preservation and restoration of health and focuses particular attention on the subluxation.”^9,10 The purpose of chiropractic is to “optimize health.” This vague and untestable ACC paradigm has been endorsed by the American Chiropractic Association, the International Chiropractic Association, and the World Federation of Chiropractic. The ACC notes that “Because of the emphasis on holistic health care, chiropractic is associated with the field of complementary and alternative medicine.”¹¹

Until chiropractic schools and associations draw a line (with the fanfare of a clarion call) and take a stand on the side of science as a properly limited specialty, uniformly defining and limiting chiropractic in state laws, the credibility and the status of chiropractors will remain low. Physicians will continue to refer their patients to physical therapists, physiatrists, and orthopedic surgeons rather than risk a bad outcome with inappropriate treatment provided by a chiropractor. With an increasing number of physical therapists and orthopedic manual therapists now including spinal manipulation in their treatment armamentarium, it may eventually become unnecessary to search for the manipulative services of individual science-based chiropractors who are “not like the other chiropractors.”

It seems likely that subluxation-based chiropractic, like homeopathy and other belief systems, will be perpetuated to some degree by true believers. It remains to be seen whether chiropractic will eventually split into two camps?one for science-based chiropractors and one for subluxation-based chiropractors. Hopefully, the science-based camp will eventually prevail as a majority in defining chiropractic in state laws, forcing subluxation-based chiropractors to practice surreptitiously. This may never happen. But in the archives of science, the “chiropractic subluxation” will be filed away under the label of dogma.

Nonfalsifiable Subluxation Theory Still Alive

Despite the general consensus of scientific and academic groups that the chiropractic vertebral subluxation theory is not a viable construct, the National Board of Chiropractic Examiners continues to define chiropractic as subluxation-based: “The specific focus of chiropractic practice is known as the chiropractic subluxation or joint dysfunction. A subluxation is a health concern that manifests in the skeletal joints, and, through complex anatomical and physiological relationships, affects the nervous system and may lead to reduced function, disability, or illness.”⁹

Such a definition continues to allow routine manipulation of vertebrae anywhere in the spine to “restore and maintain health” by correcting “subluxations” or “joint dysfunction.” This approach allows frequent manipulation of the cervical spine, a treatment that has been associated with stroke caused by dissection of vertebrobasilar arteries. It’s important to remember that the chances of injury are multiplied when chiropractic neck manipulation is routinely used many times on every patient in a misguided attempt to improve health, as opposed to occasional use of neck manipulation by physical therapists and other manual therapists who are concerned only about restoring mobility in a stiff spine.

In June of 2010, the Connecticut Chiropractic Board, denying that neck manipulation can be a cause of stroke, issued this statement: “After a careful and thorough review of all the testimony and documentary evidence admitted at the hearing [January 2010], the Board concludes that there is sufficient evidence to establish that a stroke or a cervical arterial dissection is not a risk or side effect of joint mobilization, manipulation or adjustment of the cervical spine.”¹² It seems unlikely that any group or organization outside of chiropractic will agree with this observation.

Because of apparent concerns that chiropractic neck manipulation based on subluxation theory involves more risk than benefit, the Kaiser Permanente Mid Atlantic States and Mid-Atlantic Permanente Medical Group recently revised their Chiropractic Manipulation Medical Coverage Policy to exclude cervical Chiropractic Manipulative Treatment (CMT). The revised policy states: “Given the paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine and the real potential for catastrophic adverse effects, it was decided to exclude chiropractic manipulation of the cervical spine from coverage.”¹³ In response, the American Chiropractic Association “…sent a letter to Kaiser outlining the extensive data that supports cervical spine manipulation as both beneficial and safe.”¹⁴

Until the schools and associations of the chiropractic profession totally abandon the vertebral subluxation theory, and state and federal laws defining chiropractic are changed, it is not difficult to understand why there might be some justification for blanket condemnation of chiropractic, despite evidence that spinal manipulation can be useful in the treatment of uncomplicated mechanical-type back problems. It does not appear, however, that the chiropractic profession might be willing to voluntarily reduce its scope of practice by renouncing the vertebral subluxation theory. At the present time, “…the 50 state chiropractic practice acts essentially define chiropractic as the detection and correction of subluxations and assume their significance to human health, allowing a broad scope of practice. Because the chiropractic profession seems unwilling to abandon these discredited concepts, reform of the state chiropractic practice acts to eliminate subluxation-based chiropractic practice may be the only viable solution to the perpetration of unscientific and unproved healthcare practices.”¹⁵

The subluxation is the yoke of the chiropractic profession. The “chiropractic subluxation,” under one name or another, continues to find shelter under the umbrella of chiropractic. Good science-based chiropractors who do not subscribe to the vertebral subluxation theory and who use manipulation appropriately can offer a service of value. Unfortunately, such chiropractors are not easy to find.

References

Rosner A. The Role of Subluxation in Chiropractic. Des Moines, IA: Foundation for Chiropractic Education and Research; 1997.
Nansel D, Szlazak M. Somatic dysfunction and the phenomenon of visceral disease simulation: a probable explanation for the apparent effectiveness of somatic therapy in patients presumed to be suffering from true visceral disease. J Manipulative Physiol Ther. 1995;18:379-397.
Mirtz TA, Morgan L, Wyatt LH, Greene L. An epidemiological examination of the subluxation construct using Hill’s criteria of causation. Chiropractic & Osteopathy. 2009;17:13. http://www.chiroandosteo.com/content/17/1/13 (Accessed August 24, 2010).
Brown R. President, British Chiropractic Association. BCA Statement on Vertebral Subluxation Complex. May 24, 2010. General Chiropractic Council Guidance on Claims Made for the Chiropractic Vertebral Subluxation Complex. http://www.gcc-uk.org/files/page_file/guidance_on_claims_for_VSC_May_2010.pdf (Accessed August 24, 2010.)
Tindle HA, Davis RB, Phillips RS, Eisenberg DM. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med. 2005;11:42-49.
Kanodia AK, Legedza AT, Davis RB, Eisenberg DM, Phillips RS. Perceived benefit of complementary and alternative medicine (CAM) for back pain: a national survey. The Journal of the American Board of Family Medicine. 2010;23(3):354-362.
Frazer J. The Golden Bough. New York, NY: The Macmillan Company; 1956.
Peterson D, Wiese G. Chiropractic: An Illustrated History. St. Louis, MO: Mosby; 1995:260-261.
Christensen M, et al. Practice Analysis of Chiropractic. Greeley, CO: National Board of Chiropractic Examiners; 2010.
Chiropractic Paradigm. Association of Chiropractic Colleges, 2010. http://www.chirocolleges.org/paradigm_scope_practice.html (Accessed August 24, 2010.)
What Is Chiropractic? Association of Chiropractic Colleges. 2010 http://www.chirocolleges.org/whatis.html (Accessed August 24, 2010.)
Connecticut Chiropractors’ Informed Consent Standard Upheld. American Chiropractic Association. June 11, 2010. http://www.acatoday.org/content_css.cfm?CID=3978. (Accessed August 28, 2010.)
No Evidence of Benefits, Health Insurer Excludes Neck Manipulations. PR Web. August 28, 2010. http://www.prweb.com/pdfdownload/4432714.pdf (Accessed Aug 28, 2010.)
American Chiropractic Association responds to new Kaiser policy excluding cervical manipulation. Chiropractic Economics. August 20, 2010. http://www.chiroeco.com/news/print-this.php?id=10075. (Accessed August 28, 2010.)
Bellamy JJ. Legislative alchemy: the US state chiropractic practice acts. FACT. 2010;15(3):214-222.

Chelation: Compounding Pharmacy’s Problems

Posted on October 17, 2010 by Danzig

Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy, facilitates this pseudoscience by manufacturing and selling chelation products.

Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:

Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.

Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.

Not that many decades ago, almost all prescriptions were custom manufactured, or compounded. The pharmacist combined raw chemicals into dosage forms like capsules, tablets, liquids and creams. Compounding allows complete customization of a prescription — from a new strength of a capsule, to a liquid form of a tablet, to creams with combinations of ingredients that can be completely individualized. With the proper equipment, even sterile injectables can be made.

These days, commercial manufacturers supply most drug products, and the need for in-pharmacy compounding has dwindled. At the same time, regulatory oversight, by agencies like Health Canada and the FDA, ensure product uniformity, purity, potency, efficacy, and safety standards for consumers. However, any pharmacy is still capable of providing compounded prescriptions, and some specialize, calling themselves “compounding pharmacies” and aggressively promoting the service. In compounding pharmacies, the same level of regulatory oversight and scrutiny does not exist. Professional Compounding Centers of America, provides training, formulations (recipes), and raw ingredients to compounding pharmacies. To pharmacies and pharmacists, compounding is a business opportunity, and an ideal way for independent pharmacies to compete against large chain stores, which typically do not offer these services.

The relationship between compounding pharmacies that prepare chelation treatments, and the practitioners that prescribe these products, is a symbiotic one — each group needs the other to offer these treatments. Consider this article in a pharmacy publication, entitled, Chelation for Antiaging: The Pharmacist’s Role, which touts the benefits of chelation:

Removing toxic metals from the body is one of the most important antiaging therapies available. The results from many scientific studies indicate that an increased accumulation (body burden) of toxic metals—such as mercury, lead, cadmium, and arsenic—increases the risk for common diseases, including cancer, cardiovascular disease, diabetes, Alzheimer’s disease, and attention-deficit/ hyperactivity disorder.

And:

Serious toxic-metal problems must be managed by an experienced physician. It is becoming increasingly recognized, however, that virtually everyone has a chronic accumulation of toxic metals in the body, which contributes to health problems and accelerates the aging process. Pharmacists who take the time to become knowledgeable about the correct use of OTC detoxification products can provide a much-needed service. At the same time, guiding customers on detoxification protocols also can become a new source of income for pharmacists who charge for their consultation time.

It’s a huge, burgeoning, evidence-free marketplace that pharmacies have stepped in to fill. College Pharmacy in Colorado has a “Hot List” of chelation protocols including the DAN! protocol — all of which can be ordered. Dallas-based ApothéCure offers a huge list of intravenous chelation options. Quantum Pharmacy in San Francisco touts a long list of benefits from EDTA infusions. Smith’s Pharmacy in Toronto offers chelation among a number of biomedical treatments for autism.

If there’s no evidence to support its use, why the persistent interest in chelation? Despite anecdotal evidence of success, my sense is chelation is simply another manifestation of sympathetic magic: specifically, contagious magic. Patients remove these non-existent “toxins” and become “cleansed” through a sciencey-looking purification ritual that is repeated dozens of times. With no objective measurement of efficacy, protocols and treatment measurements vary widely, but typically lack a defined endpoint. According to the Medical Letter, regimens of 20-50 infusions are common, at costs of $100-$300 per treatment.

Regulators have had difficulty finding a balance between allowing the legitimate practice of individualized compounding of products to meet unique patient needs, and the desire to limit pharmacy compounding as a workaround to prepare products that are pointedly not approved for use, or are used as a means of commercially selling products that require FDA evaluation and approval for sale. The FDA has taken action against a number of pharmacies who have been alleged to contravene federal food and drug regulations. There’s been little action from pharmacy regulators themselves against these practices.

Unfortunately for patients, a network of pharmacies continues to facilitate the provision of compounded chelation therapies, in the absence of any persuasive evidence to support their use. That state and provincial pharmacy regulators ignore these activities is an embarrassment to the profession of pharmacy, and consumers quite literally are paying the price.

When (Anti-Vax) Politics Intrudes

Posted on October 17, 2010 by Danzig

Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.

Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.

Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.

Another issue that frequently is caught between politics and science is vaccinations – and just such a conflict is heating up in Florida. Penn Bullock and Brandon K. Thorp report in the Miami News Times that a wealthy chiropractor, Gary Kompothecras, is using his political connections, earned by generous campaign contributions, to promote his apparent anti-vaccine agenda. Kompothecras has two children with autism and he blames thimerosal in vaccines for their condition. Readers of SBM know that thimerosal (which contains ethyl mercury) has not been connected to autism. The scientific evidence overwhelmingly shows that vaccines are not to blame. Most notably with regard to thimerosal specifically, this preservative was removed from most childhood vaccines over 8 years ago in the US, and autism rates have not plummeted as proponents of the thimerosal hypothesis predicted. Yet some, like Kompothecras, still cling to this discredited notion.

A year ago Kompothecras (who calls himself the “rainmaker” – a reference to his political connections) was pushing for a law that would have weakened Florida’s vaccine requirement for public school. Such measures are always sold as parent choice or health freedom, but they are really just anti-vaccine. The bill, which is still languishing, would outlaw certain vaccines with thimerosal and would allow parents to space out and delay vaccines.

This is a good example of the disconnect between science and politics – there is no evidence that delaying or spacing out vaccines has any health benefit, but it does leave children vulnerable to preventable diseases for longer. So delaying vaccines has risk but no benefit.

This is therefore an example of one man who is using political connections to push for legislation that is not based upon science and runs contrary to the consensus of expert opinion.
Kompothecras is now at it again, using political pressure to “bully” the Florida department of health into releasing confidential vaccine records. Kompothecras is a friend and contributor to governor Charlie Crist, and was appointed to the governor’s task force on autism (a scary thought in itself). He wants the DOH to give this confidential information to the infamous father and son team of Mark and David Geier.

We have written extensively about them as well – most significantly their recent trial of lupron (a chemical castrating agent) and chelation therapy (a risky procedure) for autism. The Geiers have been publishing research alleging to show a connection between vaccines and autism, but their results are at odds with other researchers and seem highly flawed and dubious on review. Bullock and Thorpe summarize their career thusly:

Since Mark Geier embraced the autism theory, his appearances in federal courts have led judges to label his testimonies “intellectually dishonest” and “not reliable.” The Institute of Medicine has called his work “uninterpretable.” The American Academy of Pediatrics said one of his studies exhibited “numerous conceptual and scientific flaws, omissions of fact, inaccuracies, and misstatements.”

Now, I am always in favor of transparency of information. As we learned with climate gate, keeping data from those who you perceive to have an anti-scientific agenda can backfire. But confidential medical records are not temperature data. There is an issue of confidentiality that needs to be dealt with. Medical information can be released for legitimate research that is in the public interest – but there’s the rub.

The Geiers have a dubious scientific history of misinterpreting data, apparently to serve an anti-vaccine agenda and to support their lucrative practice of treating alleged mercury poisoning. No one has a right to perform medical research, or a right to privileged medical information. You have to earn the privilege of access by being an ethical and legitimate researcher. In my opinion, the Geiers do not meet these criteria.

Apparently the Florida DOH agrees, but the normal process of assessing the legitimacy of requests for information is being subverted by political pressure from a wealthy and connected chiropractor with an apparent anti-vaccine agenda.

This is a bit of a no-win scenario for the DOH – whether or not they release the data it can be used for anti-vaccine propaganda purposes. Perhaps one compromise would be to release the data to an independent panel of researchers with no conflicts of interest to do an independent and transparent analysis.

Conclusion

Unfortunately, this example of using political pressure to subvert science is not isolated. In many states there are laws to subvert the vaccine program, or to protect dubious practitioners from being held to the standard of care.

The bigger issue is that “alternative medicine” is an industry that has learned to use the political process to advance their interests over that of the consumer and the public health.

Eric Pearl “Reconnects” with Hands-Off Healing

Posted on October 17, 2010 by Danzig

I first became aware of chiropractor Eric Pearl through the reprehensible movie The Living Matrix. Several months ago I reviewed that movie and described its segment featuring Pearl as follows:

A 5 year old with cerebral palsy was allegedly healed by “reconnective healing” by a chiropractor who is shown waving his hands a few inches away from the child’s body. Problem: There was no medical evaluation before and after to determine whether anything had objectively changed, and video of the child after treatment shows that his gait is not normal.

I have since learned that Pearl is far more than an eccentric oddball. He is a whole industry. He is teaching his “reconnective healing” methods to others worldwide through seminars in several languages, he engages in aggressive marketing, he offers practice-building advice to his many disciples, and he even foists his beliefs on groups of impressionable young children. I use the word disciples intentionally because there are strong religious overtones to this healing method.

What is Reconnective Healing?

“The Reconnection” is similar to therapeutic touch, but goes much farther. He does not need to physically touch patients because they can feel his touch without any contact. They close their eyes and he moves his hands around their bodies but several inches away. They feel a presence, see colors unknown on Earth, and often see angels (one particular angel is George, a multicolored parrot). Afterwards, they report miraculous healings of “cancers, AIDS-related diseases, epilepsy, chronic fatigue syndrome, multiple sclerosis, rheumatoid and osteoarthritis, birth disfigurements, cerebral palsy and other serious afflictions.”

How Did He Learn to Do This?

He discovered this new ability after a “Jewish gypsy” (!?) read his cards at Venice Beach and “Almost as an afterthought she said to me, ? [sic]There’s a very special work that I do through the use of axiatonal lines. It reconnects your body’s meridian lines to the grid lines on the planet that connect us to the stars and other planets.” She told him he could read about it in the Book of Enoch. (I couldn’t stand to read that book, but I skimmed it and didn’t notice anything that seemed pertinent to healing; if readers can find the pertinent sections, I’d appreciate it if they would point them out to me.) He returned for a couple of healing sessions; her fee was $333. Later, at home, a light by his bedside turned on by itself and he thought there were people in his home, that he was not alone and was being watched. He began to have other unusual experiences such as strange sensations and vibrations in his skull and legs, and he started hearing music and sounds. (In psychiatric parlance, the word for this is “hallucinations.”) Then his chiropractic patients started reporting similar unusual experiences, seeing angels and experiencing miraculous healings.

He learned that “God is the healer.”

Not only did the energy know where to go and what to do without the slightest instruction from me; the more I got my attention out of the picture the more powerful the response. Some of the greatest healings occurred when I was thinking about my grocery list.

Then he discovered he could transmit these abilities to others.

He teaches you how to activate and utilize this new, all-inclusive spectrum of healing frequencies that allow us to completely transcend “energy healing” and its myriad “techniques” to access a level of healing beyond anything anyone has been able to access prior to now!

So what is it? Something he does, or something that a mysterious energy spontaneously does when his attention is elsewhere? A spectrum of healing frequencies, or God, or angels, or axiatonal lines connecting us to the stars, or what? It doesn’t appear that he has even tried to think this through or form any coherent hypothesis.

What About Evidence?

His website is full of miraculous testimonials. These amount to what the courts call hearsay. For all we know, he or his patients could have made these stories up. He offers no medical documentation. The only attempt at any objective evidence is a ridiculous, meaningless pair of Kirlian photos of his hands during and prior to healing mode. He has never even tried to do a properly blinded, controlled test to see if patients really can sense his hands without contact. He’s not about evidence, he’s about belief.

Conclusion

According to the philosopher David Hume’s guidelines for determining whether reported miracles have really occurred, it seems more probable that Pearl’s testimony is misguided than that the phenomena he reports are real. It is far more likely that his claims are explainable through a number of well-documented human foibles: delusion, illusion, hallucination, imagination, fantasy, suggestion, misperception, misinterpretation, and inaccurate reporting. If he wants us to believe there is anything more substantial going on, the burden is on him to test his abilities and offer meaningful evidence. He’s not likely to do that: he has no motivation to test the reality of something he believes in, and he’s garnering far more fame and fortune than he ever could have as a chiropractor. It’s ironic that the etymology of chiropractic implies “hands-on” and that he is now practicing “hands-off.” I’m guessing he’s not a deliberate fraud, but merely self-deluded and lacking in critical thinking skills. His intellectual level is revealed by his own statement that

Books and I never got along. By this point in my life I had maybe read two books, and one of them I was still coloring.

He offers his patients false hope: he is probably harming at least some of them by keeping them from getting real help with their medical problems. Buyer beware!

The mammography wars heat up again

Posted on October 17, 2010 by Danzig

PRELUDE: THE PROBLEM WITH SCREENING

If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can appear to be inconsistency, and that seeming inconsistency is all too often an opening for quackery. Even when there isn’t an opening for quackery, it can cause a lot of confusion; some physicians are often resistant to changing their practice. It’s not for nothing that there’s an old joke in medical circles that no outdated medical practice completely dies until a new generation of physicians comes up through the ranks and the older physicians who believe in the practice either retire or die. There’s some truth in that. As I’ve said before, SBM is messy. In particular, the process of applying new science as the data become available to a problem that’s already as complicated as screening asymptomatic people for a disease in order to intervene earlier and, hopefully, save lives can be fraught with confusion and difficulties.

Certainly one of the most contentious issues in medicine over the last few years has been the issue of screening for various cancers. The main cancers that we most commonly subject populations to routine mass screening for include prostate, colon, cervical, and breast cancer. Because I’m a breast cancer surgeon, I most frequently have to deal with breast cancer screening, which means, in essence, screening with mammography. The reason is that mammography is inexpensive, well-tested, and, in general, very effective.

Or so we thought. Last week, yet another piece of evidence to muddle the picture was published in the New England Journal of Medicine (NEJM) and hit the news media in outlets such as the New York Times (Mammograms’ Value in Cancer Fight at Issue).

Before I discuss the study, let’s look at the background. As I’ve written about over the last couple of years, evidence has been accumulating that is muddying the picture regarding the benefits of screening mammography, So let’s be clear on what we are discussing here: screening mammography is different from diagnostic mammography in that it is performed at regular intervals in asymptomatic women in order to detect cancer at an earlier stage and thereby allow earlier intervention, resulting in the saving of more lives than if we waited until breast cancer produces symptoms (such as a lump) that lead to diagnosis. If a woman feels a lump or some change in her breast and undergoes mammography, that is not screening. In that case, mammography is being done for diagnostic purposes. We are not discussing diagnostic mammography. We are discussing screening mammography. I can’t emphasize that distinction enough.

What we’re discovering is not that screening mammography is ineffective, but rather that it is probably not as effective as advertised in preventing death from breast cancer, which, let’s face it, is the primary reason we subject women over age 40 to mammographic screening. The reason is that phenomena such as overdiagnosis and overtreatment, coupled with lead time and length time bias, conspire to confound what conceptually is very simple but in practice is very complex indeed, catching breast cancer at an earlier stage and thereby saving lives. Overdiagnosis, for instance, is the diagnosis of cancer that, for whatever biological reason, would never threaten the life of the patient because it either progresses so slowly that the patient dies of natural causes before it ever reaches the point of endangering the patient’s life, never progresses at all, or possibly even spontaneously regresses. Because we do not yet have reliable methods to distinguish indolent tumors from those that will grow and metastasize, we as cancer doctors have the moral obligation to treat all tumors discovered by screening as though they could potentially kill the patient. These treatments are often not benign, and can include surgery, radiation, and even chemotherapy. Overdiagnosis leads to overtreatment, and overtreatment is not a benign thing either. Unfortunately, until recently we haven’t always taken into account the potential harm from overtreatment into account or the biology of the various cancers and the very nature of screening itself, which preferentially detects more indolent disease.

As a result of the accumulation of evidence suggesting less benefit from mass screening programs than we had hoped and more potential harm than we had feared, the oncology world has been rethinking screening for cancer, in particular for prostate and breast cancer. Clearly, the most problematic cancer to screen for has been prostate cancer, because the common blood test used to detect it, prostate-specific antigen (PSA) is fraught with false positives, leading to morbid surgery (prostatectomy) or somewhat less morbid radiation therapy to treat early lesions that probably would never develop into life-threatening cancer. After all, autopsy series have shown that approximately 75% of men over the age of 80 have small foci of cancer in their prostate glands, but nowhere near 75% of men die of prostate cancer. In other words, more men die with prostate cancer than from it, and most are asymptomatic. That is why the American Cancer Society no longer recommends routine PSA screening.

Screening for breast cancer is less problematic, because mammography has a lower incidence of false positives, but, as we have been discovering, it’s still problematic. As many as one in three breast cancers may be overdiagnosed by mammography; as many as one in five mammographically-detected breast cancers in asymptomatic women might spontaneously regress. As a result of accumulating evidence, last fall the United States Preventative Services Task Force (UPSTF) revised its recommendations for screening mammography to recommend that it begin at age 50 rather than age 40. The resulting kerfuffle led to emergency meetings at various cancer centers regarding how to reassure women. From my perspective, it was depressing how much we seemed to concentrate on “damage” control and protecting the current recommendations, rather than explaining the new recommendations.

Enter this new Norwegian study, hot off the presses.

DECREASED BREAST CANCER MORTALITY: DUE TO SCREENING OR BETTER TREATMENT?

I first became aware of the new study from a Google News Alert that led me to a NYT story by Gina Kolata entitled Mammograms’ Value in Cancer Fight at Issue:

A new study suggests that increased awareness and improved treatments rather than mammograms are the main force in reducing the breast cancer death rate.
Starting in their 40s or 50s, most women in this country faithfully get a mammogram every year, as recommended by health officials. But the study suggests that the decision about whether to have the screening test may now be a close call.
The study, medical experts say, is the first to assess the benefit of mammography in the context of the modern era of breast cancer treatment. While it is unlikely to settle the debate over mammograms — and experts continue to disagree about the value of the test — it indicates that improved treatments with hormonal therapy and other targeted drugs may have, in a way, washed out most of mammography’s benefits by making it less important to find cancers when they are too small to feel.
Previous studies of mammograms, done decades ago, found they reduced the breast cancer death rate by 15 to 25 percent, a meaningful amount. But that was when treatment was much less effective.

It should come as no surprise to regular readers that the commonly accepted estimate of how much mammographic screening of a population reduces the death rate from breast cancer is around 20-25%. These numbers are based on randomized clinical trials, most of which were carried out more than 20 years ago. Based on these trials, many countries instituted mass screening programs using mammography. Because it would violate clinical equipoise, given that it is generally accepted that screening mammography decreases deaths from breast cancer, there will likely never be another randomized, controlled clinical trial of mammography, even though technology has progressed and we have better treatments that may affect the outcome. That leaves observational studies, a less rigorous form of evidence, to investigate the issue. However, it is still quite possible to obtain useful data from such studies, and that is what this Norwegian group did when they examined the effect on breast cancer mortality of introducing mammographic screening programs. The results, published in the September 23 issue of the NEJM, provide an unexpected, even startling, answer.

This study, Kalager et al, was performed in a very clever manner. To understand how it was carried out, it’s necessary to know a bit about Norway first. Norway is a nation of 4.8 million people that, because it has a centralized public health care system, has records far more complete and centralized than anything we have in the United States. In brief, this is a study that could never have been done in the US:

Norway, with a total population of 4.8 million, has a public health care system. Patients generally receive treatment in their county of residence, and there is no private primary care for breast cancer.⁸ The nationwide Cancer Registry of Norway is close to 100% complete.^9,10 Patients are identified in the registry by their individually unique national registration number, which includes the date of birth. The registry runs the Breast Cancer Screening Program, which began as a pilot project in 4 of the 19 Norwegian counties in 1996. Two years later, the government decided to expand the program, and over a period of 9 years, the remaining 15 counties were enrolled in a staggered fashion¹¹ The rollout of the program followed no specific geographic pattern. Since 2005, all women in the country between the ages of 50 and 69 years have been invited to participate in screening mammography every 2 years.
Before enrollment in the program, each county was required to establish multidisciplinary breast-cancer management teams and breast units.¹² As a result, breast-cancer management became centralized for all residents within each county, and dedicated teams of radiologists, radiologic technologists, pathologists, surgeons, oncologists, and nurses managed the care of all patients, regardless of age.

The study followed, in essence, a staggered cohort design. The authors compared rates of breast cancer deaths based on incidence in four groups: one group of women who during the years of the rollout of the mammography screening program (1996 to 2005) were living in counties with screening (the screening group); one group of women who were living in counties without screening during that time (the nonscreening group); and two groups of historical controls who from 1986 to 1995 mirrored the screening and nonscreening group. They then analyzed data from 40,057 women with breast cancer during that period of time. In order to try to isolate the effect of the breast cancer screening program, they calculated mortality in the screening group including only deaths from breast cancer in women who had received the diagnosis after the screening program was implemented. This avoids inclusion of breast cancer deaths that occurred after the implementation of the screening program that were actually diagnoses that were made before the screening program.

In addition, the authors divided up Norway’s 19 counties into six regions, chosen for having entered the screening program at approximately the same time. Death rates were then compared separately for each region, allowing similar followup times for each region. In addition, this strategy allowed for the comparison of trends in mortality from breast cancer over time. They then performed these analyses:

First, we compared women in the nonscreening group with their historical counterparts to determine the temporal change in mortality that was not attributable to the introduction of the screening program and that was likely to reflect improved treatment and earlier clinical diagnosis. Then, we compared women in the screening group with their historical counterparts to determine the change in mortality after implementation of the screening program. In this second comparison, the difference in the rate of death between the two groups can be attributed both to the screening program and to temporal trends in mortality that were unrelated to the screening program. Thus, the reduction in mortality that was related to the screening program was the difference between the rate ratio for death among women in the screening group as compared with their historical counterparts and the rate ratio for death among women in the nonscreening group as compared with their historical counterparts.

To boil it down, using this method, the authors could come up with two numbers for improvement in breast cancer mortality over time, an improvement not attributable to screening, which is therefore attributable to better treatments, and a number that is attributable both to screening and better treatments. The result is a graph (click to enlarge):

As can be seen, the estimate for how much of the improvement in mortality due to breast cancer between the two time periods in Norway is due to mammography is attributable to screening mammography is approximately one third of the overall improvement (10% out of an overall improvement of 28%). Moreover, statistically, there is enough uncertainty in this estimate that it could be as little as 2% of the decrease in breast cancer mortality that is due to mammographic screening. Most of this improvement in survival was observed in women with stage II tumors:

Among women between the ages of 50 and 69 years in the screening group, those with stage I tumors had a relative reduction in mortality of 16%, as compared with their historical counterparts (rate ratio, 0.84; 95% CI, 0.63 to 1.11); among women in the nonscreening group, the corresponding reduction was 13% (rate ratio, 0.87; 95% CI, 0.62 to 1.23). Among women with stage II tumors, those in the screening group had a marked 29% reduction in mortality, as compared with their historical counterparts (rate ratio, 0.71; 95% CI, 0.58 to 0.86); among women in the nonscreening group, the reduction was 7% (rate ratio, 0.93; 95% CI, 0.76 to 1.12).

Among women with more advanced tumors (stage III and stage IV), there was no effect attributable to screening. Although there was still a 30% reduction in mortality in this group, none of it could be attributed to screening. Intuitively, this makes sense; stage III and stage IV tumors are generally detected clinically because of symptoms, not in a screening program. It also intuitively makes sense that the death rate from stage I tumors would be less affected than that from stage II tumors because (1) stage I tumors would be much more likely to be overdiagnosed by screening and (2) the followup time in this study is relatively short (8.9 years for the group with the longest followup), which may not be sufficient time for the full benefit of screening to show for earlier stage tumors; and (3) stage II tumors can still be detected mammographically in asymptomatic women but, because they are more advanced, have already shown themselves to be potentially deadly. It should also be conceded that, because of improvements in imaging and in detection of lymph node metastases (such as sentinel lymph node biopsy), this result might also be partially due to selective stage migration among those who undergo screening. If that were the case, part of the improvement in survival among those with stage II disease could be apparent rather than real.

Being retrospective, this study is, of course, not bullet-proof. As the authors themselves concede, the maximum followup time of only 8.9 years may be too short for a full benefit to have been seen. In addition, because the screening program was rolled out gradually in the counties, diagnoses were made more recently in the screening group, which may actually overestimate the benefit associated with the screening program. Finally, it’s possible that, because the multidisciplinary breast cancer teams were established before the screening program was rolled out, it’s possible that some of the women in the nonscreening group might have undergone mammography associated with this, thus “contaminating” the nonscreened group and lowering the apparent benefit of screening. The authors offer several reasons why they think this latter problem is unlikely to have been significant, including how limited access to mammography was before screening programs were implemented, the fact that there was no financial incentive to providers to order mammography, and because, as expected, the implementation of the screening program in the various counties resulted in a substantial increase in the number of diagnoses of breast cancer, with no similar trend in counties that had not yet joined the screening program.

Overall, because most of the more recent observational studies of mammographic screening use historical controls without an attempt to control for the confounding variable of temporal downward trends in breast cancer mortality, the authors conclude that the benefit of screening in terms of decreasing a woman’s odds of dying from breast cancer is smaller than previously estimated. In aggregate, they estimate that, in Norway at least, approximately one-third of the decrease in breast cancer mortality is due to screening, and two thirds to other factors, which (we hope) includes better treatment.

MAMMOGRAPHY: A LONG RUN FOR A SHORT SLIDE?

Not surprisingly, there was an accompanying editorial. I was, however, rather surprised at who was chosen to write the editorial, namely Dr. Gilbert Welch, a long-time critic of screening mammography, who entitled his article Screening Mammography — A Long Run for a Short Slide? Personally, I was expecting that any accompanying editorial would be written by an advocate of mammographic screening. The crux of his argument is in this paragraph:

The juxtaposition of such a charged medical debate in the face of such an exhaustive scientific investigation is in itself instructive. For context, one trial involving fewer than 150 men who were followed for less than 2 years was sufficient to convince physicians of the value of treating severe hypertension.¹ That physicians are still debating the relative merits of screening mammography despite the wealth of data suggests that the test is surely a close call, a delicate balance between modest benefit and modest harm.

Dr. Welch is referring to this study from 1967, which found a marked difference in morbidity and mortality over a relatively short followup period in men with diastolic blood pressures ranging from 115 through 129 mm Hg. The results were so clear-cut that after that study no one could argue against treating someone with a diastolic blood pressure that high. Personally, I viewed this comparison as a bit of a cheap shot by Dr. Welch in that the study he chose looked at men with a severe health condition known to predispose to stroke, myocardial infarction, and other complications. He compared this clinical situation to the screening of an asymptomatic population, where it’s known going in that it will be harder to show benefits, requiring a lot of patients and a lot of followup. That aside, though, Dr. Welch is correct that more recent evidence suggests that the benefits of mammography are more modest than we have traditionally been taught.

That brings us to the question of why this study found results different than the results cited by the USPSTF when making their recommendations. Dr. Welch offers two possibilities. First, this study could be wrong. That is, of course, always possible given that it is not a prospective randomized trial. However, situations change with time, and it is no longer possible to do a randomized trial to determine whether mammography saves lives. Clinical equipoise again. So all we are left with are studies like this Norwegian study, where investigators do the best they can to reduce confounders. Looking at the design of the study, I tend to agree with Dr. Welch that it is unlikely that these confounders would be enough to account for the difference between the much higher reductions in breast cancer mortality observed in early randomized studies (the ones cited by the USPSTF) and Kalager et al found. Most likely, Kalager et al is correct, or at least not too far off. That leaves several questions.

First and foremost, is a 10% reduction in mortality from breast cancer adequate to justify mass screening programs? Whenever I am asked a question like this (for example, about Avastin), my tendency is to respond that this is not a scientific question. It is a moral question that asks us to make a value judgment as a society. Think of it this way. It is estimated that approximately 40,000 women will die of breast cancer in 2010. If Kalager et al is correct and its results are applicable to the U.S., that means that, without screening, approximately 44,000 women would die of breast cancer. What are 4,000 lives worth? I can’t answer that question. Dr. Welch frames it a bit differently, to make the benefit seem even more modest:

If we assume that mammography screening is associated with a 10% reduction in the rate of death from breast cancer (making the optimistic assumption that all the benefit comes from screening mammograms), the 10-year risk of breast-cancer death for a 50-year-old woman in the United States is now about 4 per 1000 women.⁶ If we assume that this risk already incorporates the benefit of screening mammography, the risk estimate without mammography would be about 4.4 per 1000 women.

Benefits that look very modest when looked at as a risk per 1000, however, can produce fairly large absolute numbers when applied to millions of women. I tend to view Kalager et al’s results as the lower bound of estimates for the benefits of screening mammography. It wouldn’t surprise me if the true benefits are higher. Remember those 4,000 women, who are all someone’s mothers, wives, and/or daughters. However, so are the women potentially harmed:

Because we are all subject to framing effects, it is important to consider the reverse frame. The number of women who will not die from breast cancer rises from 995.6 to 996 per 1000 women with the addition of screening mammography. Although readers may each respond differently to these frames, both reflect the same absolute benefit: 0.4 per 1000 women. In other words, 2500 women would need to be screened over a 10-year period for 1 to avoid death from breast cancer.
What happens to the other 2499 women who had to undergo screening to achieve this benefit is also relevant. Estimates of harm vary considerably. In the United States, more than 1000 women would be expected to have at least one false positive result,⁷ a number that would be considerably lower in Europe.⁸ Less frequent but more worrisome is the problem of overdiagnosis. Somewhere between 5 and 15 women would be expected to be needlessly treated for a condition that was never going to bother them, with all the accompanying harms.^9,10

Another estimate that I discussed came from an article last year by Laura Esserman, who estimated that to avert one death from breast cancer with mammographic screening for women between the ages of 50-70, 838 women need to be screened over 6 years for a total of 5,866 screening visits, to detect 18 invasive cancers and 6 instances of DCIS. That’s roughly three times the benefit estimated by Kalager et al.

Whatever the true benefit of mammographic screening, how we balance the potential benefits of mammographic screening with the potential harms is more of a philosophical and moral question. Science-based medicine can inform us regarding the values of mammographic screening, but it can’t tell us what we value.

A MIDDLE GROUND?

Figuring out the benefits of screening for cancer, be it with mammography or by other means for other cancers, is by its very nature a difficult issue, full of scientific and ethical confounders. Unfortunately, this scientifically muddy issue, to be applied successfully to a mass population, is often sold uncritically and with far more confidence than the data support. Mammography is represented uncritically as pure good, and women are told that every woman should start having mammography religiously at age 40. That’s why, when the USPSTF recommendations were released last fall, which stated that screening should begin at age 50 and be offered every two years instead of every year (which, by the way, is what Norway does), the reaction against them was so vociferous, particularly given that the recommendations were released right in the midst of the debate about President Obama’s health insurance reform bill and its opponents were raising the specter of arbitrary government rationing of health care. It was science-based medicine reexamining an existing accepted belief about breast cancer and running right into the perfect storm of resistance from advocacy groups, politics, and physician practice patterns. It turns out that all too often both patients and physicians want certainty, not the ever-evolving recommendations based on new science.

Moreover, there are a lot of issues at play here, as Dr. J. Leonard Lichtenfeld of the American Cancer Society points out:

We have moved to a different age, but I have to admit that I have a bias that we run the risk of going back in part to that future. Today, with screening mammograms we find more cancers that are smaller than can be detected by physical examination and no amount of self-awareness or physician awareness is going to change that. Patients and physicians have not suddenly become more astute in their diagnostic skills. If anything, they have become less effective in that arena.
There is also downsides of our success:
We do find breast cancers today through mammography that years ago would never have been discovered and may never have caused a woman any difficulty.
We do treat more women than benefit from that treatment, but we don’t have tests that can tell us which breast cancers don’t require any treatment as compared to those which are lethal.
We have studies that show us formal, structured breast self examinations don’t appear to save lives.
We have ethnic groups in this country that have had significant reductions in breast cancer mortality and others that have not, in part because too many don’t have access to quality medical care.
In short, this is a complicated issue. I am not certain that all of the relevant facts and considerations applicable to the circumstances in the United States are necessarily reflected in this particular study. Yet I suspect the headlines will be that mammograms don’t work or that they make little difference.
We must find our way out of these dilemmas. Messaging to the public has become garbled and confusing. The sad fact is that if we make the wrong decisions about the value of screening mammography, it will be years before we find out if we were mistaken.

“Dr. Len” has a point. However, he, too, is a bit guilty of black and white thinking here. He seems to think that we either preach the benefits of mammography or not. There is, however, a third way, and this was described by Drs. Kerianne H. Quanstrum and Rodney A. Hayward, M.D. at the University of Michigan in an NEJM editorial published two weeks before Kalager et al entitled Lessons from the Mammography Wars.

After describing the violent reaction to the USPSTF guidelines, Quanstrum and Hayward pointed out two very simple things. First:

In reality, this independent panel, the Preventive Services Task Force, simply recommended that routine screening mammography begin at the age of 50 years, whereas women between the ages of 40 and 49 years should make individual decisions with their doctors as to whether their preferences and risk factors indicate screening at an earlier age. The panel also recommended that screening mammograms be performed every other year, which they suggested would reduce the harms of mammography by nearly half while maintaining most of the benefits provided by annual imaging.⁵ In short, the panel concluded that we had previously overestimated the value of mammography: that mammography is good, but not that good; that it is necessary for many women, but not all; and that it should be performed at some frequency, but perhaps not every year, for every woman.

And second:

Behind the panel’s conclusions regarding mammography lurks an unwelcome reality that our profession has often failed to acknowledge. Every medical intervention — no matter how beneficial for some patients — will provide continuously diminishing returns as the threshold for intervention is lowered. Mammography is just one case in point. For women between the ages of 40 and 49 years, the false positive rate is quite high, and the expected benefits are quite low: more than 1900 women would need to be invited for screening mammography in order to prevent just one death from breast cancer during 11 years of follow-up, at the direct cost of more than 20,000 visits for breast imaging and approximately 2000 false positive mammograms. Conversely, for women between the ages of 60 and 69 years, fewer than 400 women would need to be invited for screening in order to prevent one breast-cancer death during 13 years of follow-up, while accruing approximately 5000 visits and 400 false positive mammograms.6 In short, as the risk of breast cancer increases, the benefits of mammography increase, whereas the relative harms become progressively less significant.

Which strikes me as exactly correct. If there’s one rule of screening for any disease, it’s that the more you screen the more disease you will find, but much of it will be subclinical and much of it would likely never have killed the patient. Another rule is the law of diminishing returns. This leads to an observation, namely that for any screening test, there will be a population for whom the benefits clearly outweigh the risks, one for whom the risks clearly outweigh the benefits, and one for whom the answer is not so clear. What we have now is a model in which a threshold is set and there is in essence a binary system: Screen or don’t screen. What Quanstrum and Hayward argue is that there should be three options, which they represent thusly (click to enlarge):

And, it seems to me, that’s all that the USPSTF was suggesting: That for women without other risk factors for breast cancer between the ages of 50 and 70 the benefits of mammography clearly outweigh the risks. For women without other risk factors for breast cancer under age 40, the risks outweigh the benefits. For women between 40 and 50, the answer is unclear, and these women should discuss the issue with their doctors and come to a decision based on a frank discussion of the benefits and risks, acknowledging that screening may not be right for some women under 50, while for others it is. The problem is, binary decision-making is easier than more complicated models.

In the end, that’s probably what drives me the most batty about debates over screening for breast cancer. It’s not a black-and-white question, but advocates and physicians who become invested in the status quo sell it as such. Evidence and the science change, but policy recommendations become fossilized because certainty is perceived as being better than nuance. I will admit that three or four years ago I probably would have been one of the docs circling the wagons in the face of these new studies. No longer. I also detest the “other side,” who represent mammographic screening as useless because the benefits appear to be more modest than we originally believed. I believe that patients are far more capable than we give them credit for of understanding and acknowledging that there are gray areas in medicine. We should not be selling certainty when there is none.

Short Attention Span SBM

Posted on October 17, 2010 by Danzig

The bar on this blog is set high. The entries are often complete, with no turn left unstoned. Yet, not every topic needs the full monty with every post. The blog has extensive evaluations on many topics, and new medical literature doesn’t require another complete analysis. Many new articles add incrementally to the literature and their conclusions need to be inserted into the conversation of this blog, like a car sliding into heavy traffic. My eldest son just received his driver’s license, and car metaphors are on my mind. As are crash metaphors and insurance metaphors.

So in response to this need, a need only recognized by me, I give you Short Attention Span SCAM. Occasionally I will summarize a few recent studies and their key points as they relate to prior posts at SBM.

Influenza

…any man’s death diminishes me, because I am involved in mankind, and therefore never send to know for whom the bells tolls; it tolls for thee. — John Donne

Influenza season will be starting soon. There are multiple misstatements made about influenza and its treatment in the SCAMosphere. The first concerns death. Flu does not kill, or so it is asserted, or it only kills a thousand people a year. During last year’s H1N1 season I took care of a pair of patients who died of acute influenza, not its complications. Direct deaths from influenza are always a fraction of the deaths from indirect causes: worsening of heart failure or lung disease or a secondary infections. I try to never use the word ‘only’ when discussing direct flu deaths; perhaps I take it too personally. Not patient of mine was ever an ‘only’ and it annoys me no end when the deaths of others are diminished.

How influenza deaths are calculated was discussed in the past, but the CDC released new information on influenza deaths from 1976 to 2007. Calculating flu deaths is not easy. The number lies somewhere between direct deaths from flu, and the deaths from other acute, but related causes:

Deaths from pneumonia and influenza causes are highly correlated with the circulation of influenza and can be considered a lower bound for deaths associated with influenza. However, a diagnosis of influenza virus infection often is not confirmed with sensitive and specific laboratory diagnostics, particularly among older persons, and even when identified is rarely recorded on death certificates (5). Many deaths associated with influenza infections occur from secondary infections such as bacterial pneumonia or complications of chronic conditions such as congestive heart failure and chronic obstructive pulmonary disease. Therefore, estimates using underlying respiratory and circulatory mortality data (which include pneumonia and influenza causes) can provide an upper bound for influenza- associated deaths.

The striking result is that, on average, there is no average flu season. Deaths vary from year to year and depends on the circulating strain of influenza.

Over 31 consecutive flu seasons, on average there were about 23,600 deaths a year linked to the flu varying from a low of 3,349 deaths in 1986-1987 to a high of 48,614 in 2003-2004.

When H3N2 predominated, deaths were 2.7 times higher than compared to other strains. As a comparison, 8,330 to 17,160 are estimated to have died from H1N1.

The ‘classic‘ number given is about 36,000 deaths a year, but the number is an average and, like so much in medicine, it depends. As the CDC says,

A single estimate should not be used to summarize influenza-associated deaths; a range of estimates should be described in the context of circulating virus strains and underlying causes of death among age groups.

Death is often a bad outcome and it is better to not die of the flu or its complications. A recent case controlled study compared flu vaccinated vs unvaccinated and found that the receipt of the flu vaccine decreased the risk of heart attack.

We included 78 706 patients, of whom 16 012 were cases and 62 694 were matched controls. Influenza vaccination had been received in the previous year by 8472 cases (52.9%) and 32 081 controls (51.2%) and was associated with a 19% reduction in the rate of acute myocardial infarction (adjusted odds ratio [OR] 0.81, 95% confidence interval [CI] 0.77-0.85). Early seasonal influenza vaccination was associated with a lower rate of acute myocardial infarction (adjusted OR 0.79, 95% CI 0.75-0.83) than vaccination after mid-November (adjusted OR 0.88, 95% CI 0.79-0.97).

The authors do not speculate on the mechanism of the protection, but that will not stop me. Infections are pro-inflammatory and pro-thrombotic. Myocardial infarctions, strokes and pulmonary embolisms are increased during and after acute infections, perhaps in part due to increased stress on the heart, but also, perhaps due to the pro-thrombotic state. It is reasonable to suggest that flu leads to increased inflammation and thrombosis which leads to MI. No flu, no pro-thrombotic state, no MI. If one could “boost the immune system“, and you can’t, what you would get is a inflammatory/thrombotic state that should lead to more vascular events: strokes, MI and pulmonary embolism.

Vitamin D

Dont get the vaccine, many a site will say, all you need is vitamin D to prevent and treat flu. I am not going to deny the importance of having sufficient vitamin D to keep immune function optimal.

Having higher vitamin D serum levels does decrease the risk of a viral infection, although the effect is modest.

During 114 days of the fall and winter in a temperate zone a serum concentration of 25-hydroxyvitamin D of 38 ng/ml or higher was associated with a two-fold decrease (p<0.0001) in the risk of developing acute viral infections of the respiratory tract.

A modest decrease in risk, and enough to keep me drinking milk shakes all winter to keep my vitamin D levels elevated.

The question is, if you supplement vitamin D in patients, can you treat or prevent influenza? There is zero data for influenza. But there is data for viral upper respiratory tract infections. In Finland they they did a placebo-controlled double-blinded study in 164 young Finnish men (1828 years of age) who were randomly assigned to 400 IU (10 mg;) vitamin D3 daily or placebo.

The treatment and placebo group had the same initial levels of Vitamin D and a difference in levels at the end of the trial.

Intervention (78.7+- 14.9nmol/L) and placebo (74.4+- 20.8 nmol/L groups (P p .35)…after daily supplementation with 400 IU vitamin D or placebo for 6 months, the mean serum 25(OH)D concentrations were 71.6 +- 22.9 nmol/L in the intervention group and 51.3 +- 15.5 nmol/L in the placebo group.

Let’s see: moles to molecular weight to Avogadro’s number to … it’s late and I am tired and do not have there intellectual wherewithal to convert nmol/l to mg/ml. I must have a homeopaths understanding of concentrations. I will leave that as an exercise for the comments (yes, it is also fun to whitewash a fence) to see if they started at the 38 ng/ml that was effective to decreasing risk. Hey. I can’t be expected to do everything can I?

The results were, again, modest.

The main outcome variable, which was the number of days absent from duty due to respiratory tract infection, did not differ between groups. Mean number of days absent was 2.2 +-3.2 days in the intervention group and 3.0+-4.0 days in the placebo group . There was an effect during the first 6 weeks of the study, with a mean of 0.7+-2.1 days of absence in the intervention group and 1.4 +- 2.6 days absent in the placebo group. After the first 6 weeks, there tended to be no difference between groups. Nevertheless, the proportion of men remaining healthy throughout the 6-month study period was greater in the intervention group (41 [51.3%] of 80) than in the placebo group (30 [35.7%] of 80).

Not impressive, but something, and when it comes to avoiding illness, something is better than nothing. Better still, being replete in vitamin D will increase the response to the flu vaccine, so taking vitamin D, especially if you are deficient, may increase the antibody levels after the flu vaccine, still the best way to avoid the disease.

So would I suggest vitamin D? Yes, as part of a healthy breakfast and if you are deficient. It is one of a number of interventions you can use to prevent getting ill in the viral season. But is vitamin D the be-all and end-all of flu prevention and treatment. No. Not even close.

Acupuncture

Man is the only animal that blushes. Or needs to. — Mark Twain

Acupuncture is all placebo effect, what ever that is. This was re-confirmed in “A randomized controlled trial of acupuncture for osteoarthritis of the knee: Effects of patient-provider communication“.

In this trial, patients had real acupuncture or sham acupuncture (as if there is a difference) and they had neutral or enthusiastic acupuncturists. Those that had an enthusiastic acupuncturist had a better decrease in reported pain, whether the acupuncture was real or sham.

TCA was not superior to sham acupuncture. However, acupuncturists styles had significant effects on pain reduction and satisfaction, suggesting that the analgesic benefits of acupuncture can be partially mediated through placebo effects related to the acupuncturists behavior.

This result is of no surprise. Expectations will often color people’s perceptions. More expensive wine is rated higher than the same vintage labeled as cheaper. An expensive placebo is more effective than an cheap placebo.

But does perception of reality mean reality was altered?

I play golf with my kids almost every night in the summer and towards the end of the season I get right elbow tendinitis. As I make my downswing the pain fibers fire and can mess up my swing if I am not focused on hitting through the pain. If I take 400 milligrams of ibuprofen before I play, I have less pain and my swing is unchanged. Not enough to beat my son, but that is another matter.

Decreasing pain leads to improved function when pain limits function. If you have a musculoskeletal problem, you usually have a reproducible limit to your function due to the pain. If the pain is decreased, the function should improve.

As I have discussed at length, I do not think there is really a placebo effect. Certainly for objective endpoints, there is no placebo effect. Buried in the acupuncture paper were two objective end points: range of motion and the Timed Up and Go Test. For objective endpoints there were no changes in any of the groups. So it makes me wonder just what improvement these patients ‘really’ had. Subjectively better, objectively no change.

Is the placebo effect no more than a patient convincing themselves they are better when in fact nothing has changed? That is my interpretation. If function is not improved, if they are still limited by pain, is the pain really gone? Is this response a milder example of the same cognitive processes that can lead to hysterical blindness or not seeing tumors the size of a large mushroom? Man is the only animal with the ability to convince themselves that the tangible is unreal or that the unreal is tangible.

“Always keep your words soft & sweet in case you have to eat them!”

I have said numerous times that I was envious of SCAM practitioners as they live an essentially never-changing world. Once the ideas of homeopathy, reiki, acupuncture were codified, there is no change. Learn once … use forever.

Not so, it turns out, thanks to a report in Medscape (COI warning: I am a paid Medscape blogger).

New acupuncture points have been discovered! Acupuncture advances.

We generally modify acupoints to make them effective and more appropriate for cancer patients…For example, the acupoints which are predetermined places on the body where needles are inserted for therapeutic effect for hot flashes for normal menopause are “not necessarily the same ones for early menopause due to chemotherapy”.

Unfortunately, this breakthrough in acupuncture has yet to be published, although this pioneering work was done at Memorial Sloan-Kettering Cancer Center. Evidently, the only way you can learn this incredible clinical breakthrough is by paying $495 dollars and taking the online acupuncture class offered by Sloan-Kettering. I guess there are some medical cures they really dont want you to know about unless you pay first. It worked for Kevin Trudeau, it works for Sloan-Kettering.

When this phenomenal pioneering work is finally published, I suppose in the NEJM, I will have a second helping of words.

So ends the first SAS SBM.

Taking Customer Service to the Next Level [Video]

Posted on October 17, 2010 by Danzig

Chris Valderrama. The man. The myth. The legend. Some say he’s “Stig” on Top Gear. Some say he wrote his first fully functional operating system just after his first birthday. Some say the Seinfeld episode where George naps under his desk was inspired by the fully furnished studio apartment he built in a file cabinet in his office. Some say when he orders donuts, his minimum order is a baker’s dozen dozen (13 x12 = 156.) All I can say is that he’s the manager of The Planet’s technical support department, and he’s a crazy smart guy.

At the 2010 cPanel Automation Bootcamp, Chris was the headlining speaker in a session titled “From Happy Customers to Loyal Customers: Taking Customer Service to the Next Level.” He discussed some of the problems inherent in scaling support, what characteristics support managers should look for in new hires, setting support goals, choosing metrics and evaluating performance. If your business is support-centered, you’ll get a lot out of his presentation:

[See post to watch the Flash video]

If you want to see what else you missed at this year’s Automation Bootcamp, check out the Bootcamp Hoedown wrap up video cPanel posted. What to watch for in that video: Few familiar faces from The Planet, incredible shots of the Server Challenge, some line dancing and people getting thrown off a mechanical bull.

-Kevin

Heading South, Looking Up

Posted on October 17, 2010 by Danzig

For most of the past decade the last thing I would do before going to bed was to step out on to my back patio and stare up at the sky for a few minutes, checking for clouds. If the skies were clear I always slept better. In the morning, I would hop out of bed and do the same thing, to see if any unexpected weather front had passed or cirrus had snuck in while I had been sleeping. If all was well with the skies, I knew that my robotic telescope 95 miles southeast of me, likely had a successful night scanning the skies, and I was excited to get up and get to my office to see the results. I knew that any clear night we might (and eventually did!) discover something larger than anything else ever seen past Neptune. It was just a matter of time and of keeping those pesky clouds away.

Too many clouds

Whenever I found anything, I would quickly tell the two other guys working with me on the project, Chad Trujillo at the Gemini Observatory and David Rabinowitz at Yale University, and we would scheme what to do next to learn even more.

While clouds would come and go, there was something even more substantial blocking much of our view of the sky: the earth. From our spot at a latitude of 33 degrees north, there were many constellations in the southern hemisphere that we could never see. We would never know if something was flying past the constellation Tucana (the toucan), swimming through the constellation Volans (the flying fish), or disguised with the constellation Chameleon (the, um, chameleon).

Five years ago, right after we found Haumea, Eris, and Makemake in quick succession in the northern hemisphere, everyone asked: When are you headed south?

It was an obvious thing to do. The northern skies were quickly being exhausted, the southern skies were relatively untouched. Like any good whaler who has successfully depleted his prime hunting grounds, I knew it was time to wait for next breeze to push me over the equator and into the southern seas.

But I wasn’t going to go.

It’s true that finding more objects was so appealing: each of these largest discoveries beyond Neptune has painted us a unique picture of the early history of the solar system. Finding even a few more would substantially increase our understanding of this otherwise mysterious time period. But for this same reason, I couldn’t take the time to go look for more. Each of the objects that we found was indeed so interesting that I decided that it made more sense to spend the time studying them in detail rather than looking for more. We studied the tiny moons of Eris and Quaoar and Haumea. We developed theories for the unexpected slabs of frozen methane on Makemake and even predicted that we should see the same thing on Quaoar (and we DID!). We went down a rabbit hole with Haumea and found an unexpected world of icy rocks, dancing satellites, and the biggest Humpty Dumpty puzzle known in the solar system. And we spent years trying – and still not yet succeeding – to understand Sedna.

Making more discoveries in the southern hemisphere would be fun, but whenever anyone asked, I simply said: I’m not going to do it, but you should.

That’s not quite as crazy an idea as you might think. Given the right equipment and a sufficiently obsessive personality, mounting such a telescopic survey is not that hard to figure out how to do. After all, I had never done one until I did the one I did. And I muddled by somehow. I made a few mistakes along the way that I later thought through and fixed, but I always promised anyone who asked that I’d be more than happy to give them more advice than they could ever want.

But no one ever took me up on my offer.

Still, I had other things to keep me occupied. I was playing with data from the Cassini spacecraft on fog and lake-effect clouds on Titan and teaching a new generation of Caltech undergraduates how to understand such things. I was not going to go south.

But.

Then I got antsy.

It had been too long.

I didn’t mind if someone else was going to make the discoveries, but I was getting frustrated that no one was going to make the discoveries.

So I cracked.

The new Skymapper telesccope at Siding Spring

With a little discussion I got involved with a group from the Australian National University who were building a fancy new telescope to survey the whole southern skies in what they called the Skymapper project. It was going to be perfect, though the telescope and camera were still under construction, so it would take some time still. Michelle Bannister, a graduate student at ANU, took the project on as her Ph.D. thesis, and, with the beauty of Skype, I have yet to get on an airplane even once for this project.

As it turns out, I was not the only person getting antsy. A few months later I got word that another survey in the south was soon to be underway. The survey was going to take place using an old telescope that had been refurbished and an old camera that had been shipped south. The old camera? The same one we had used at Palomar! The survey was being run by my old collaborator David Rabinowitz, who, too, must have tired of no one doing anything. It seemed likely to me that refurbishing an old camera and telescope was going to be faster than building a new one. To get things going even faster, David even hired my recently graduated Ph.D. student Meg Schwamb -- who had been working on the northern survey -- to run the southern survey. It seemed to me that Michelle and I were now in second place, and that David and Meg were going to be the likely winners of the race to the southern hemisphere. We stepped up our efforts to at least make it a fair fight and try to have a chance.

Out of nowhere, though, a third group appeared. This group, predictably, now, includes my other old collaborator Chad Trujillo (the group is run by Scott Sheppard out of Carnegie Observatory, who, many years ago, was one of those people to whom I had said: you should do the southern hemisphere; shockingly, people occasionally take my advice!). Scott and Chad are using an existing camera and an existing telescope. Existing cameras and telescopes trump refurbished cameras and telescopes trump still-under-construction cameras and telescopes. I resigned myself to third place.

Having a friendly but serious race definitely makes things much more fun, but being the likely third place survey when attempting to discover new objects in the outer solar system is not particularly useful. Once a discovery has been made, everyone else is a has-been. Or perhaps never-was. There is actually no such thing as third place.

The Uppsalla 0.5 m telescope

Unbeknownst to anyone, though, Michelle and I have a secret weapon. While it is true that existing cameras and telescopes are great, they still lose to one thing: existing data. For the past 10 years the Siding Spring Survey has searched for near earth asteroids from the moderately small Upssalla telescope at Siding Spring Observatory in Australia (right next to the new Skymapper telescope being built, in fact). The pictures that the Uppsalla telescope takes night after night have been fabulous for detecting the motion of the occasional fast moving tiny rocks that might someday come slamming into us, but these pictures were never designed for finding the much more slowly moving distant objects that we wanted to see. To the Uppsalla telescope, the things we want to discover are so far away and moving so slowly that they might as well be the stars of the Milky Way. But over the past year Michelle and I have developed a huge software package to go back over 10 years worth of pictures and try to pull out the distant slowly moving objects.

The good news? We are potentially back in virtual first place. The bad news? We’re only in first place for a small number of the very brightest objects, and those might not exist. The Upsalla telescope would only be capable of detecting the very brightest of the know objects in the northern part of the outer solar system: Pluto, Eris, Makemake, Haumea, maybe Quaoar and Orcus. So if there is something that bright in the south, we should find it first. The chances, though, are only moderate. Remember, our northern survey could see a good bit of the way south, so the southern survey really only have about 1/3 of the sky to look at, and it is 1/3 of the sky that is somewhat far from the disk of the solar system. So my best guess is that there will be one or zero really bright objects down there. We’ll know the answer before anyone else, but unless the answer is one, rather than zero, no one will particularly care!

The one fun thing that I like to ponder as I think about the fresh skies of the southern hemisphere is just how fresh they really are. When we were looking at the northern skies we knew that 70 years ago Clyde Tombaugh had been there first. Sure, we could see things 100 times fainter than Clyde, but we knew that we were unlikely to stumble across anything as bright as, say, Pluto. The southern skies have never even had a Tombaugh. I’ve been spending free moments idly speculating on how bright the brightest slowly moving thing could be in the south that would have escaped detection. Is there any reason something as bright as Pluto would have been found if it existed in the southern skies? I don’t think so. You could probably even hide something a few times brighter and get away with it.

Does this mean something twice the size of Eris is lurking in the southern hemisphere, waiting to be pulled out of the old data? I don’t think so. But it might be.

These days I don’t look at the sky last thing before going to bed each night. And I don’t check for clouds first thing in the morning. I do the seemingly much more mundane tasking of picking up my phone from beside my bed, using it to log in to my server on the Caltech campus, checking that all of the processors are humming away sorting through 10 years worth of data, and waiting to see what gets spit out. Is there anything in the old pictures? I don’t yet know, but it’s just a matter of time and keep those pesky computers running smoothly.

Blog Action Day 2010 | Water

Posted on October 17, 2010 by Danzig

Blog Action Day 2010 is trying to raise awareness around the globe on the issue of water resources. Right now, almost a billion people on the planet don’t have access to clean, safe drinking water. That’s one in eight of us.

Unsafe water and lack of basic sanitation cause 80% of diseases and kill more people every year than all forms of violence, including war. Children are especially vulnerable, as their bodies aren't strong enough to fight diarrhea, dysentery and other illnesses. The UN predicts that one tenth of the global disease burden can be prevented simply by improving water supply and sanitation.

But, water moves beyond just a human rights issue. It’s an environmental issue, an animal welfare issue, a sustainability issue. Water is a global issue, deserving a global conversation.

The following are just a few of many reasons why this is such an important issue:

A Human Right: Safe and clean drinking water and sanitation is a human right essential to the full enjoyment of life and all other human rights, the General Assembly of the UN declared July 28, 2010, voicing deep concern that almost 900 million people worldwide do not have access to clean water.

The United Nations expresses deep concern that an estimated 884 million people lack access to safe drinking water and a total of more than 2.6 billion people do not have access to basic sanitation. Studies also indicate about 1.5 million children under the age of five die each year and 443 million school days are lost because of water- and sanitation-related diseases.

Cell Phones vs Toilets: Today, 2.5 billion people lack access to toilets, but many more have access to a cell phone. This is a sad fact.

Today’s water crisis is not an issue of scarcity, but of access. More people in the world own cell phones than have access to a toilet. And as cities and slums grow at increasing rates, the situation worsens. Every day, lack of access to clean water and sanitation kills thousands, leaving others with reduced quality of life.

Food Footprint: It takes 24 liters of water to produce one hamburger. That means it would take over 19.9 billion liters of water to make just one hamburger for every person in Europe.

Relieving hunger in Africa and around the world has to begin with access to clean water. It may seem simple, but we forget that without access to a reliable source of water, food is hard to grow and even more difficult to preserve and prepare. It takes huge amounts of water to grow food.

Blog Action Day 2010: Water from Blog Action Day on Vimeo.

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The Vertical Farm Concept

Posted on October 17, 2010 by Danzig

The Problem

Vertical Farm Concept By the year 2050, nearly 80% of the earth's population will reside in urban centers. Applying the most conservative estimates to current demographic trends, the human population will increase by about 3 billion people during the interim. An estimated 109 hectares of new land (about 20% more land than is represented by the country of Brazil) will be needed to grow enough food to feed them, if traditional farming practices continue as they are practiced today. At present, throughout the world, over 80% of the land that is suitable for raising crops is in use (sources: FAO and NASA). Historically, some 15% of that has been laid waste by poor management practices. What can be done to avoid this impending disaster?

A Potential Solution: Farm Vertically

vertical farming The concept of indoor farming is not new, since hothouse production of tomatoes, a wide variety of herbs, and other produce has been in vogue for some time. What is new is the urgent need to scale up this technology to accommodate another 3 billion people. An entirely new approach to indoor farming must be invented, employing cutting edge technologies. The Vertical Farm must be efficient (cheap to construct and safe to operate). Vertical farms, many stories high, will be situated in the heart of the world's urban centers. If successfully implemented, they offer the promise of urban renewal, sustainable production of a safe and varied food supply (year-round crop production), and the eventual repair of ecosystems that have been sacrificed for horizontal farming.

Vertical Farm It took humans 10,000 years to learn how to grow most of the crops we now take for granted. Along the way, we despoiled most of the land we worked, often turning verdant, natural ecozones into semi-arid deserts. Within that same time frame, we evolved into an urban species, in which 60% of the human population now lives vertically in cities. This means that, for the majority, we humans are protected against the elements, yet we subject our food-bearing plants to the rigors of the great outdoors and can do no more than hope for a good weather year. However, more often than not now, due to a rapidly changing climate regime, that is not what follows. Massive floods, protracted droughts, class 4-5 hurricanes, and severe monsoons take their toll each year, destroying millions of tons of valuable crops. Don't our harvestable plants deserve the same level of comfort and protection that we now enjoy? The time is at hand for us to learn how to safely grow our food inside environmentally controlled multistory buildings within urban centers. If we do not, then in just another 50 years, the next 3 billion people will surely go hungry, and the world will become a much more unpleasant place in which to live.

Advantages of Vertical Farming

Year-round crop production; 1 indoor acre is equivalent to 4-6 outdoor acres or more, depending upon the crop (e.g., strawberries: 1 indoor acre = 30 outdoor acres)

No weather-related crop failures due to droughts, floods, pests

All VF food is grown organically: no herbicides, pesticides, or fertilizers

VF virtually eliminates agricultural runoff by recycling black water

VF returns farmland to nature, restoring ecosystem functions and services

VF greatly reduces the incidence of many infectious diseases that are acquired at the agricultural interface

VF converts black and gray water into potable water by collecting the water of evapotranspiration

VF adds energy back to the grid via methane generation from composting non-edible parts of plants and animals

VF dramatically reduces fossil fuel use (no tractors, plows, shipping.)

VF converts abandoned urban properties into food production centers

VF creates sustainable environments for urban centers

VF creates new employment opportunities

We cannot go to the moon, Mars, or beyond without first learning to farm indoors on earth

VF may prove to be useful for integrating into refugee camps

VF offers the promise of measurable economic improvement for tropical and subtropical LDCs. If this should prove to be the case, then VF may be a catalyst in helping to reduce or even reverse the population growth of LDCs as they adopt urban agriculture as a strategy for sustainable food production.

VF could reduce the incidence of armed conflict over natural resources, such as water and land for agriculture

Check Out This YouTube Video

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1000+ EV Charging Stations Slated for Oregon I-5 Corridor

Posted on October 17, 2010 by Danzig

Fast EV chargers will be placed in Portland, Eugene, Salem, and Corvallis as part of a plan to install 1,100 charging stations in Oregon by July! Car manufacturers and charging companies want to eliminate anxiety related to electric-vehicle's also known as "range anxiety".

Another company, Eaton Corp., will modify and integrate electric-vehicle quick chargers at a plant in Wilsonville, OR in the Portland Metro Region.

The announcements come as representatives of ECOtality Inc., a San Francisco company, sign up Oregon companies and retail chains as locations for publicly accessible chargers. Gov. Ted Kulongoski said in a statement Wednesday that electric vehicles mean economic opportunity.

"This is just the beginning of new, private investments because of our commitment to moving the entire Pacific Northwest away from fossil-fuel vehicles," Kulongoski said of Eaton's venture.

Charging-station companies are racing to install units as auto manufacturers prepare to launch electric vehicles. Electric-vehicle owners will install charging equipment in their homes or businesses. But they will also be able to charge batteries at commercial chargers on the road.

Fast chargers, capable of recharging batteries in 15 to 30 minutes, will be concentrated along the Interstate 5 corridor. But the great majority of the 1,100 units scheduled for installation will be "level two" chargers, which motorists might use for anywhere from 45 minutes to two-to-three hours, said David Mayfield, ECOtality area manager for stakeholder services in Oregon.

The slower chargers may be desirable for retail businesses that want customers to stick around and shop a while.

ECOtality is the project manager for a $230 million installation initiative, about half of which is funded by the U.S. Energy Department using stimulus money. The EV Project, the world's largest rollout of electric-vehicle infrastructure, includes 16 states and major metropolitan areas, installing more than 15,000 charging stations during three years.

Oregon cities, government agencies, utilities and other entities have helped ECOtality develop maps identifying high-priority areas for chargers. The maps take into account factors including transportation routes, employment centers and zoning.

Only about 310 charging stations in the 16 states will be fast chargers, said Caitlin Cieslik-Miskimen, an ECOtality spokeswoman. Oregon will get at least 23 of the fast chargers, Mayfield said.

Electric-vehicle drivers could plug into the slower level-two chargers "if they wanted to top off a battery," Cieslik-Miskimen said, "or just get a little bit of extra juice so they can get home."

"We'll make sure downtown Portland has a lot of chargers that are accessible," she said.

In Wilsonville, Eaton plans to work on a quick charger for the North American market capable of recharging an electric vehicle to 80 percent of battery capacity in 15 to 30 minutes. Eaton, a Cleveland-based power-management company, employs 85 at the 80,000-square-foot plant.

The work force will remain the same for the new project, said Kelly Hubbard, account executive with Largemouth Communications. She did not know how many chargers the plant will produce.

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No More Bullying the Bull Trout

Posted on October 17, 2010 by Danzig

New Habitat Designations Aim to Recover this Threatened Species

The U.S. Fish and Wildlife Service recently revised the 2005 critical habitat designation for bull trout (Salvelinus confluentus), a threatened species found throughout much of the Pacific Northwest and protected under the federal Endangered Species Act.

Approximately 18,975 miles of streams and 488,252 acres of lakes and reservoirs in Idaho, Oregon, Washington, Montana and Nevada are being designated as critical habitat for the wide-ranging fish. In Washington, 754 miles of marine shoreline are also being designated.

“This action is the result of an extensive review of the Service’s previous bull trout critical habitat proposals and designation, as well as comments and new information received during the 2010 public review process,” said Robyn Thorson, Regional Director of the Service’s Pacific Region. “Our biologists worked hard to ensure the best science was used to identify the features and areas essential to the conservation of bull trout rangewide.”

“Bull trout depend on cold, clear water and are excellent indicators of water quality,” Regional Director Thorson said. “Protecting and restoring their habitat contributes not only to the recovery of the species but to the water quality of rivers and lakes throughout their range.”

Once plentiful, bull trout were found in 60 percent of the Columbia River Basin but now occur in less than half their historical range, with populations remaining in portions of Oregon, Washington, Idaho, Montana and Nevada. In the Klamath River Basin, bull trout occur in 21 percent of their historical range. They were listed in1999 as a threatened species throughout their range in the lower 48 U.S. states.

Bull trout are primarily threatened by habitat degradation and fragmentation, blockage of migratory corridors, poor water quality, the effects of climate change and past fisheries management practices, including the introduction of non-native species such as brown, lake and brook trout.

The designation, developed by a team of federal scientists with input from peers outside the agency, is intended to provide sufficient habitat to allow for genetic and life history diversity, ensure bull trout are well distributed across representative habitats, ensure sufficient connectivity among populations and allow for the ability to address threats facing the species.

If we take steps now to protect the good habitat that’s left and restore what’s degraded, we’ll not only save and recover bull trout and other salmonids. We’ll be helping ourselves and leaving a legacy we can be proud of to future generations.

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Alternative Recycling Options

Posted on October 17, 2010 by Danzig

Ecycler.com creates a new way to recycle by connecting people discarding recyclables (cans, bottles, newspapers, etc.) with those wishing to collect them.

Ecycler provides an alternative to the many U.S. households, institutions or businesses that are not offered curb-side recycling. It's also an option for people who have to pay for curb-side recycling or who want to have their recyclables picked up when and where they desire.

For the individual (or group) collecting recyclables, ecycler provides an entrepreneurship opportunity. Ecycler is driven by these collectors who establish an ecycler recycling program in their community. Collectors can download personalized business cards and posters generated by ecycler.com and then post them in public places. Collector accounts also include a customizable ecycler URL, i.e., their profile page. Anyone who has access to the Internet can become an ecycler collector.

Discarders can do their part for the environment while at the same time helping collectors in need of additional income. The discarders’ recyclables are “collected” by these individuals or groups and redeemed for cash at a local recycling center. Ecycler supports this community building for groups such as the Boy Scouts, Girls Scouts, Church groups, social clubs, etc. by making available the same marketing materials used by individual collectors on ecycler.com.

Ecycler encourages people to discard their recyclables for free; however, discarders can request a portion of the proceeds from the collector. Discarders can track their carbon credits on the site. In addition to the automated calculation of materials recycled though ecycler.com, discarders have the option of listing how many recyclables they've given away on their own to be included in their total.

Ecycler.com provides an accountability tool by allowing collectors and discarders to rate their experiences with one another.

CONTACT:
Timothy Laurent
recycle@ecycler.com

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A World of Health: Connecting People, Place, and Planet

Posted on October 17, 2010 by Danzig

Northwest Earth Institute, a Portland – based sustainability education and action nonprofit is excited to announce our new course, A World of Health: Connecting People, Place, and Planet! We create and distribute a series of nine small-group discussion guides on a variety of current topics. Our newest discussion based program examines the connections between our personal health and the health of our natural and physical environments, and how we can sustain both. The curriculum consists of six sessions, including video, reading, an action plan, and group discussion questions. The overall goal of the curriculum is to increase awareness of the connections between health and the environment and inspire people to take actions that promote overall good health.

In the past two weeks more than 500 participants have pre-ordered the A World of Health curriculum, and an estimated 5,000 are expected to participate over the coming year. The curriculum is part of an on-going effort by NWEI to educate and inspire people to make small lifestyle changes that have a long-term, positive benefit for themselves and the planet. Since its launch in 1993, more than 125,000 people in all 50 states have participated in NWEI discussion courses.

“Our goal with this curriculum is to help people explore the link between personal and environmental health and provide individuals with inspiration and ideas to help them live healthier lives,” said Mike Mercer, executive director, Northwest Earth Institute. The expectation is that by making small changes in their daily lives, people will improve their personal health and also –their impact on the environment which sustains us.”

With the new A World of Health curriculum, NWEI aims to provide a wide range of actions participants can take to improve their personal health, and in turn, reduce their ecological footprint. While the course is not prescriptive in nature these are a few of the actions that come up for consideration:

Use a reusable bag to haul groceries—plastic bags aren’t biodegradable and, when discarded, become problematic for people and wildlife alike. And shop smart—the stuff in the bag has a larger impact than the bag itself.

Examine your food products for packaging that contains bisphenol A (BPA), a chemical with harmful health consequences.

Map the accessibility of your neighborhood via walking and biking to encourage to a healthier lifestyle while also reducing our dependence on fossil fuels.

Consider the broader health impacts brought about by a consumer-based culture.

Make your own household cleaners. They cost much less, are just as effective and are a safer alternative to relying on harsh, toxic commercial products. Effective cleaning products can be made with borax, washing soda, distilled white vinegar, baking soda, salt, club soda, cooking oil and lemons. On their own or combined together, you can make scouring powder, furniture polish, an all-purpose cleaner and more!

The Northwest Earth Institute is recognized as a national leader in the development of innovative programs that empower individuals and organizations to transform culture toward a sustainable and enriching future. Today, NWEI offers nine study guides for small groups. These self-guided discussion courses are offered in workplaces, universities, faith centers, neighborhoods, community centers, and individuals throughout North America. Through discussion with others, each program encourages participants to explore values and attitudes, and then take action on behalf of the planet. Check out our other course books and blog at http://www.nwei.org!

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