Salt therapy: Where's the evidence?

Today there was a Groupon offer for salt therapy from the "Salt Chalet Arizona."  Sufferers of respiratory illnesses are offered the chance to sit in a room containing salt for claimed relief of symptoms.  I posted the following at the Salt Chalet Arizona's blog, which is awaiting moderation:

“Although there have been few clinical studies” — are there any that provide any empirical support for the claims made on this site? It seems to me that solid empirical support for safety and efficacy are absolutely essential requirements for any medical claim. What is the mechanism of relief, is that relief more than would be expected from a placebo effect, does it last, and are there any harmful short or long term consequences?

To its credit, the blog's repost of a newspaper article about a similar service offered via a Pakistani salt mine includes the following skeptical passage:

But Shahid Abbas, a doctor who runs the private Allergy and Asthma Centre in Islamabad, said that although an asthma or allergy sufferer may get temporary relief, there is no quick-fix cure.

“There is no scientific proof that a person can permanently get rid of asthma by breathing in a salt mine or in a particular environment,” he said.

Discredited doctor comes to Phoenix

British former surgeon Andrew Wakefield, whose discredited and abusive research was responsible for the resurgence of measles outbreaks in the UK and the U.S., is not just coming to Phoenix this Saturday, he is being celebrated by the Autism Society of Greater Phoenix at the Ritz Carlton Hotel.  Wakefield's 1998 paper in The Lancet reported symptoms of inflammatory bowel disease in twelve children with autism, and speculated that the cause was the MMR (measles, mumps, rubella) vaccine.  What it didn't report was that Wakefield had a financial interest in his own alternative vaccine, that he had been paid by attorneys who were trying to prove that MMR vaccines were harmful, that his test subjects were recruited by those attorneys from among their plaintiffs, or that Wakefield engaged in unnecessary colonoscopies, colon biopsies, and spinal taps on children in his study.  Ten of Wakefield's 12 co-authors published a retraction of his interpretation of the paper, and the original paper was withdrawn by the journal this year.  Wakefield's name has been struck from the register of British medical doctors as a result of his unethical behavior.

The publication of his paper was responsible for a significant drop in UK vaccination rates due to fear of a link to autism, which was accompanied by a rise in measles outbreaks (but no drop in autism diagnosis rates).

It is a pity that the Autism Society of Greater Phoenix is promoting an unethical, discredited quack.

Personalized medicine research forum

Yesterday afternoon I attended a Personalized Medicine research forum at ASU's Biodesign Institute, sponsored by ASU's Office of the Vice President for Research and Economic Affairs (OVPREA) and hosted by Dr. Joshua LaBaer of ASU's Virginia G. Piper Center for Personalized Diagnostics.

The forum's speakers covered both the promise and problems and issues raised by the developing field of personalized medicine, which involves the use of molecular and genetic information in medical diagnosis and treatment. A few highlights:

Introduction (Dr. LaBaer)
Dr. LaBaer pointed out that these new diagnostics cost a great deal of money to develop, but they have the potential for cost savings, for instance, if they can be used to identify forms of disease that will not benefit from very expensive treatments. He gave the example of Genomic Health, which has developed a test for early stage breast cancer to determine if women will or won't benefit from adjuvant therapy (chemotherapy to prevent recurrence). A test that costs even a few thousand dollars to perform is something insurers will be willing to pay for if it has the potential of saving tens of thousands of dollars of expense on chemotherapy that will not provide any benefits. On the other hand, the mere promise of early detection of susceptibility for disease has the potential for overtreatment and an increase in healthcare expenses. This problem was discussed by a number of speakers, with particular bad potential consequences in the legal realm.

Personalized Diagnostics (Dr. LaBaer)
Dr. LaBaer talked briefly about his own lab's work in biomarker discovery and cell-based studies. In biomarker discovery, his lab is working in functional proteomics, using cloned copies of genes to produce proteins and building tests that allow examination of thousands of proteins at a time. His lab, formerly at Harvard and now at ASU, has 10,000 copies of human genes and 50,000 copies of genes from other animals, which are made available to other researchers. (There's more information at the DNASU website.)

The goal of biomarker discovery is to greatly improve the ability to find markers of human health using the human immune system, by identifying antigens that are markers for disease. The immune system generates antibodies not just in response to infectious disease, but against other proteins when we have cancer. Tumor antigens get into the bloodstream, though they may only appear in 10-15% of those who have the disease. Rather than testing one protein at a time, as is done with ELISA assays, LaBaer's lab is building protein microarrays with thousands of proteins, tested at once with blood serum. Unlike old array technology that purifies proteins and puts them into spots on arrays, where the proteins may degrade and lose function, their method involves printing the DNA that encodes the gene on the arrays, then capturing proteins in situ on the array at the time the experimental test is performed.

LaBaer's lab's cell-based work involves tryng to identify how proteins behave in cells when they are altered, in order to find out which pathways contribute to consequences such as drug resistance in women with breast cancer, as occurs with Tamoxifen. If you can find the genes that make cancer cells resistant, you can then knock them out and cause those cells to die. They tested 500 human kinases (5/7 of the total) and found 30 enzymes that consistently make the cancer cells resistant. Women with a high level of those enzymes who take Tamoxifen have quicker relapses of cancer.

Complex Adaptive Systems Initiative (George Poste)
George Poste, former director of ASU's Biodesign Institute and former Chief Scientist and Technology Officer at SmithKline Beecham, talked about the need to replace thinking about costs in the healthcare debate with thinking about value. The value proposition of personalized medicine is early detection, rational therapeutics where treatment is made based on the right subtype of disease being treated, and integrative care management where there's better monitoring of the efficacy of treatments. He said that the first benefits will come from targeted therapy and this will then overlap with individualized therapy, as we learn how our genome affects such things as drug interactions. He was critical of companies like 23andme, which he called "celebrity spit" companies, which do little more than give people a needless sense of anxiety about predispositions to disease that they currently can do nothing about except eat right and exercise.

Poste also had criticisms for physicians, pointing out that it takes 15-20 years for new innovations to become routinely adopted, and many physicians don't use treatment algorithms at all. Oncologists, he said, make money from distributing treatments empirically (that is, figuring out whether it's effective by using the treatment on the entire population with the disease) rather than screening first, even where tests exist to determine who the treatment is likely to work on. He said that $604 million/year in health care costs could be saved by the use of a single colon cancer screening test, and not proceeding with treatment where it isn't going to work. Today, where 12-40% of people are aided by treatments that cost tens of thousands of dollars, 60-88% of that spending is being wasted. With the aging population, he said that Humana will in the next several years see all profits disappear, spent on expensive treatments of people who don't respond to them.

Pharmaceutical companies are beginning to do diagnostic test development alongside drug development now, and insurers will push for these tests to be done. Poste suggested that we will see the emergence of "no cure, no pay" systems, and noted that Johnson & Johnson has a drug that has been introduced for use in the UK under the condition that the company will reimburse the national health care system for every case in which it is used but doesn't work. Merck's Januvia drug for type II diabetes similarly offers some kind of discount based on performance.

Poste pointed out another area for potential cost savings, related to drug safety. With some 3.1 billion prescriptions made per year, there are 1.5-3 million people hospitalized from drug interactions, 100,000 deaths, and $30 billion in healthcare costs, though he noted this latter figure includes caregiver error and patient noncompliance.

He bemoaned the "delusion of zero risk propagated by lawyers, legislatures, and the media," and pointed out that the FDA is in a no-win situation. (This is a topic that's been recently covered in two of my classes, my core program seminar and my law, science, and technology class with Prof. Gary Marchant. If the FDA allows unsafe drugs to be sold, then it comes under fire for not requiring sufficient evidence of safety. If, on the other hand, it delays the sale of effective drugs, it comes under fire for causing preventable deaths. The latter occurred during the 1980s with AIDS activists protesting against being denied treatments, described in books such as Randy Shilts' And the Band Played On and Steven Epstein's Impure Science. This led to PDUFA, the Prescription Drug User Fee Act of 1992, under which drug companies started funding FDA drug reviewer positions through application fees to help speed approval. That has been blamed for cases of the former, with the weight-loss drugs Pondimin and Redux being approved despite evidence that they caused heart problems. That story is told in the PBS Frontline episode "Dangerous Prescription" from November 2003.)

Poste pointed out that there have been 450,000 papers published which have claimed to find disease biomarkers, of which the FDA has approved only five. But he didn't blame the FDA for delay in this case, because this consists of a mass of bad studies which he characterized as "wasteful small studies" with insufficient statistical power. In the Q&A session, he argued that NIH needs to start dictating clear and strong standards for disease research, and that it has abrogated its role in doing good science. He said that "not a single national cancer study with sufficient statistical power" has been done in the last 20 years; instead research is fragmented across academic silos. He called for "go[ing] beyond R01 grant mentality" and building the large, expensive studies with 2,500 cases and 2,500 controls that need to be done.

He also raised challenges about the "very complex statistical analysis required" in order to do "multiplex tests" of the sort Dr. LaBaer is trying to develop. And he pointed out the challenge that personalized medicine presents for clinicians, in that "only about six medical schools have embraced molecular medicine and engineering-based medicine." Those that don't use these new techniques as they become available, he said, "will open themselves up to malpractice suits."

Science and Policy (David Guston)
David Guston, co-director of ASU's Consortium for Science, Policy, and Outcomes (CSPO) and director of ASU's Center for Nanotechnology in Society (CNS) spoke about "cognate challenges in social science" and how CNS has been trying to develop a notion of "anticipatory governance of emerging technology" and devising ways to build such a capacity into university research labs as well as broader society, to allow making policy decisions in advance of the emergence of the technology in society at large. He described three capacities of anticipatory governance--foresight, public engagement, and integration, and described how these have been used at ASU.

Foresight: Rather than looking at future consequences as a linear extrapolation, CNS has used scenario development and a process of structured discussions based on those scenarios with scientists, potential users, and other potential stakeholders, about social and technical events that may be subsequent consequences of the scenarios. This method has been tested with Stephen Johnston's "Doc-in-a-Box" project at ASU's Center for Innovations in Medicine, which Guston said led to some changes in the conceptualization of the technology.

Public Engagement: The "scope and inclusion of public values is important for success," Guston said, and gave as an example the "national citizens technology forum" that CNS conducted in six locations to look at speculative scenarios about nanotechnology used for human enhancement. These were essentially very large focus groups whose participants engaged in "informed deliberation" over the course of a weekend, after having read a 61-page background document and spending the prior month engaging in Internet-based interaction.

Integration: Guston described the "embedding of social scientists in science and engineering labs," to develop productive relationships that help lab scientists identify broader implications of their work while it's still in the lab rather than after it's introduced to the general public.

Guston suggested that there might be other ways of implementing "anticipatory governance" in the form of legislative requirements or standards and priorities set by program officers at funding organizations, but that the lab setting is "the best point of leverage at a university" and can set an example for others to follow.

Clinical Perspective (Larry Miller)
Larry Miller, Research Director at the Mayo Clinic in Scottsdale, spoke about the healthcare provider's approach to personalized medicine. He said that Mayo is committed to individualized care, and that now that we are beginning to understand the power of human variation, these new developments have "to be transformational for providers or they won't survive." He suggested that the future of medicine will move from reactive and probabilistic to more deterministic selection of treatments based on diagnoses. He emphasized the need for education for doctors, and pointed out that "standards of care will become outmoded," which is "disruptive to law and [insurance] coverage." He said that Mayo sees a big challenge of complexity, where what was one disease (breast cancer) is now at least ten different subdiseases. Doctors need to make their treatment decisions on the detail, to predict how the disease will behave, and choose the best drugs possible based on safety, effectiveness, and cost-effectiveness.

Miller pointed out that this requires interdisciplinary work, and said that Mayo in Arizona has a huge advantage with its relationship with ASU, where so much of this work is going on. While Mayo has scientific expertise in a number of areas, these new technologies draw on expertise from beyond medicine, in particular informatics and computational resources needed to build an effective decision support system that will become essential for doctors to use in a clinical setting.

He talked about Mayo's program for individualized medicine, which involves not just incorporating new developments in diagnostics and therapeutics, but in regenerative medicine for repair, renewal, and regeneration of deficits.

Mayo has had electronic medical records for the last 15 years, on 6 million people, but these are kept in multiple incompatible systems and were not built with research in mind. They hope to improve their systems so that it can be used in an iterative process to learn more about the efficacy of therapies, and so therapies can be combined with "companion diagnostics for monitoring progression, recurrences, and response to therapy."

Like Poste, he raised objections to the companies that market gene sequencing directly to individuals, which just "scare people inappropriately," but identified learning about disease predispositions as an important part of these developing technologies. We need to develop methods of risk analysis that can help people correctly understand what these predispositions mean.

He sees the future as having three waves--the first wave will be the new diagnostics, the second wave improvements in clinical practice and therapy, and the third wave embedding the new technology into the healthcare system, with significant changes to policy and education.

Health Informatics (Diana Petitti)
Diana Petitti, former CDC epidemiologist and former director of research for Kaiser Permanente, where she built a 20-year longitudinal data repository for its 35 million members, spoke about the importance of health informatics. (She is now a professor in ASU's Department of Biomedical Informatics.) Dr. Petitti raised concerns about how in the United States we are "loathe to deny anyone anything" in terms of medical treatments, but in fact "we do deny lots of people lots of things." She worried that personalized medicine has the potential to lead to greater maldistributions of healthcare, with the "haves" getting more and better treatment and the "have nots" getting less and worse treatment, unless we plan carefully. She advocated evidence-based medicine and assessing value of treatments to be deployed to the general population.

Dr. Petitti brought up as an example the fact that oral contraceptives result in a 2x-10x increase in the likelihood of a venous thrombotic event, and that the Factor V Leiden gene is predictive of susceptibility to that consequence, but no screening is done for it. Why not? Because the test only predicts 5% of those who will have the event, it's a very expensive test, and we don't have good alternatives for oral contraceptives. These kinds of issues, she suggested, will recur with multiplex diagnostics.

She explicitly worried that "we have dramatically oversold preventive medicine" and doesn't think it's likely that savings from prevention will allow coverage for more extensive treatment. She advocated that everyone in the field see the film "Gattaca," and stated that ASU provides "unique opportunities to train people to think about these issues" using "quantitative reasoning and probabilistic thought." She concluded by saying that we need to "work towards rational delivery of healthcare that optimizes public health."

Law (Gary Marchant)
Prof. Gary Marchant of the Sandra Day O'Connor School of Law at ASU, who has a Ph.D. in genetics and is the executive director of ASU's Center for the Study of Law, Science, and Innovation (formerly Center for the Study of Law, Science, and Technology), spoke about legal issues. First he listed the many programs available at ASU in the area, beginning with the genetics and law program that has been here for 10 years and was the reason he first came to ASU. Others include a new personalized medicine and law program at the Center for Law, Science, and Innovation, a planned center on ethical and policy issues regarding personalized medicine in conjunction with the Biodesign Institute, CSPO, TGEN, Mayo, etc., and research clusters at the law school on breast cancer, warfarin, and personalized medicine. He also gave a plug for an upcoming conference March 8-9, 2010 at the Arizona Biltmore sponsored by AAAS and Mayo, which also has a great deal of corporate support.

Prof. Marchant indicated that liability is the biggest issue regarding personalized medicine, and he sees doctors as "sitting ducks," facing huge risks. If a doctor prescribes a treatment without doing a corresponding new diagnostic test, and that has complications, he can be sued. If he does the diagnostic test, it shows a very low likelihood of a disease recurrence, and advises against the treatment, and then the patient ends up being one of the rare people who has the recurrence, the doctor can be sued. The doctor is really in a damned-if-you-do, damned-if-you-don't situation. The insurers and pharmaceutical companies are at less risk, since they have already developed enormous resources for dealing with the lawsuits that are a regular part of their existence. In a short discussion after the forum, I asked Prof. Marchant if doctors would be liable if they performed a diagnostic test, found that it showed a low likelihood of recurrence or benefit for a treatment, and then recommended the treatment anyway, knowing the insurance company would refuse to pay for it--would that shift the liability to the insurance company? He thought it might, though it would be unethical for a doctor to recommend treatment that he didn't actually think was necessary, and there's still the potential for liability if the insurance company pays for the treatment and the treatment itself produces complications. It seems that this problem really needs a legislative or regulatory fix of some sort, so that doctors have some limitation of liability in cases where they have made a recommendation that everyone would agree was the right course of action but a low-probability negative consequence occurs anyway.

Prof. Marchant observed that the liability issues are particularly problematic in states like Arizona, where each side in the suit is limited to a single expert witness. He said there is "no clear guidance or defense for doctors," and the use of clinical guidelines in a defense has not been effective in court, in part because doctors don't use them.

Q&A
A few additional points of interest from the Q&A sessions (some of which has already been combined into the above summaries):

Dr. LaBaer pointed out that most markers for diseases don't seem to have any role in the cause of the disease, such as CA25 and ovarian cancer. So his lab is looking not just for biomarkers, but for those that will affect clinical decisions. 4 out of 5 positive results in a mammography for breast cancer are actually cases where there is nothing wrong and the woman will not end up getting breast cancer, but some procedure ends up being undergone, with no value. So he wants to find a companion test that can tell which are the 4 that don't need further treatment.

George Poste pointed out that baby boomers are going to bankrupt the system as they reach the end of their lives, and about 70% of the $2.3 trillion in healthcare spending is spent in the last 2-3 years of life, with many treatments costing $60K-$100K per treatment cycle on drugs that add 2-3 weeks of life. The UK's National Institute of Clinical Excellence has been making what are, in effect, rationing decisions by turning down all of the new cancer drugs that have come along because they have such great cost and such minimal benefit. He asked, "how much money could you save with a 90% accurate test of who's going to die no matter what you do?"

Prof. Marchant said more about legal issues involving specimen repositories, including a case at ASU. The developer of the prostate-specific antigen (PSA) test, William Catalona, had a specimen repository with 30,000 tissue samples at Washington University, that he wished to take with him to Northwestern University when he took a new position there. He began asking patients for permission to move the samples, and 6,000 gave permission. But Washington University sued him, claiming that the samples were property of the university. Patients pointed out that their consent agreement gave them the right to withdraw their samples from future research and they had only consented to research on prostate cancer, but federal judge Stephen Limbaugh ruled in favor of the university and that patients had no property rights in their tissue. This ruling has reduced incentives for patients to consent to give specimens for research.

A current lawsuit against ASU by the Havasupai Indian tribe involves blood samples that were given for a study of diabetes by researchers who are no longer at ASU. They wanted to take the samples with them, and samples had also been given to other researchers for use in studies of schizophrenia and the historical origins of the tribe, even though informed consent was apparently only given for the diabetes research. Although this case was originally dismissed, it was recently reinstated.

Other cases involve patent protection of genetic information. About 25% of the human genome is patented, including Myriad Genetics' patent on the BRCA1 and BRCA2 genes which are predictive of breast cancer and can only legally be tested for by Myriad. This case is likely to go to the U.S. Supreme Court regarding the issue of whether human genes can be patented. The courts so far have ruled that a gene in isolation outside of the human body is patentable, even though (in my opinion) this seems at odds with the requirement that patents be limited to inventions, not discoveries. There has already been a legislative limitation of patent protection for surgical procedures for the clinical context, so that doctors can't be sued for patent infringement for performing a surgery that saves someone's life; it's possible that a similar limitation will be applied on gene patents in a clinical context, if they don't get overturned completely by the courts.

These gene patents create a further problem for the multiplex tests, since they inevitably include many patented genes. Prof. Marchant observed that someone from Affymetrix spoke at an ASU seminar and stood up and said they were building their GeneChip DNA microarrays for testing for the presence of thousands of genes, and were ignoring gene patents. They were subsequently sued. Dr. LaBaer stated that his lab is doing the same thing with cloned genes--they're cloning everything and giving them away, without regard to patents.

The session was videotaped and will be made available to the public online. I will add a link to this posting when it becomes available.

If you've read this far, you may also be interested in my summary of Dr. Fintan Steele's talk at this year's The Amazing Meeting 7, titled "Personalized Medicine or Personalized Mysticism?", in my summary of the Science-Based Medicine conference that took place just prior to TAM7, and in my short summary of Dr. Martin Pera's talk on regenerative medicine and embryonic stem cells at the Atheist Alliance International convention that took place earlier this month.

The Amazing Meeting 7: Swiss/Randi, Ouellette, anti-anti-vax panel, Nickell

This is part three of my summary of TAM7, still on Friday, July 10. Part 1 is here, part 2 is here, and my coverage of the Science-based Medicine conference begins here.

Jamy Ian Swiss and James Randi
After lunch on Friday was a conversation between Jamy Ian Swiss and James Randi about Randi's early career, beginning with an old BBC live broadcast of Randi making a radio disappear, and an escape he did in Quebec as the "Amazing Randall." They discussed Randi's early appearances on Johnny Carson's "Tonight Show," and how Carson, himself a magician, would visit Randi in his dressing room when he appeared on the show, leading show staff to wonder who this guy was, since Carson never visited other guests. Other old footage included an underwater survival stunt on "You Asked for It," in which Randi stayed underwater for an hour and 50 minutes, breaking Houdini's record. Randi was embedded horizontally in a block of ice on Boston Common for the Dick Cavett show, somewhat reminiscent of the more recent stunt by David Blaine. Footage was also shown of Randi's water can escape when he was a closing act after David Copperfield and Shibata, which Randi commented was made more difficult for him by the fact that Copperfield and Shibata were standing on the catwalk above him cracking jokes while he was supposedly drowning in the milk can (but was actually already on top of it trying to look out-of-breath and using a sponge to make his head wet again before the big reveal).

Then was shown a lot of amusing footage from Alice Cooper's "Billion Dollar Babies" tour, for whch Randi played a mad dentist and created various illusions for the stage, culminating with Alice Cooper's head being chopped off by a realistic-looking guillotine. Randi told various stories of the tour and how he came to be involved with it, saying that it paid very well and he knew he was going to get alone well when he visited the offices of Cooper's Alive Enterprise and found it was full of potted plants, all of which were dead. A DVD of the film made during that tour was recently released on DVD, which includes the original version of the film rejected by the studies, which included a bunch of comedy sketches, a few of which feature Randi.

When the tour came to Phoenix, Cooper asked Randi to sit in the audience with his mother, who wasn't aware of the nature of his show. Randi kept reassuring her--the wife of a Mormon minister--that Alice Cooper is just a character being played by her son (Vincent Furnier). Randi said that he saw Mrs. Furnier again a couple of years ago at Alice Cooper's 60th birthday party, and she remembered him and thanked him for the reassurance he provided during that show.

Footage was then shown of two version of Randi's upside-down strait jacket escape, one in Niagara Falls in January. He said it was so cold that he beard became completely frozen and he was unable to speak when he had freed himself and was brought down, until hot water was poured over his beard. He said it took two years to get permission to do that stunt, and they had the whole area blocked off so that only the film crew was present. But while he was hanging upside-down, he saw a Chinese family standing there watching him--they had gone sneaking through the woods to get there and watch the performance up close.

The second version of the escape was for the Japanese show "Supermen" and was performed while hanging upside-down from a helicopter flying around Tokyo. Randi, who does not like heights, said he kept telling himself, "I'm doing it for the money."

Jennifer Ouellette on the Science and Entertainment Exchange
Jennifer Ouellette, executive director of the National Academy of Science's new Science and Entertainment Exchange project and author of the book The Physics of the Buffyverse, spoke about the project. She began with a short film clip from the TV show "Numb3rs" that illustrated a scientific point about geographic profiling by reference to the physics of water drops from a sprinkler head, which she used as an example of the productivity of having scientists and entertainment producers working cooperatively.

She observed that science and Hollywood have had a love/hate relationship. Hollywood sees scientists as nitpickers who don't understand entertainment, which she depicted with a reference to an episode of "The Big Bang Theory" which pointed out that the ending of the film "Superman" was unbelievable not because of the time travel but because if Superman caught Lois Lane while she was falling at 32 feet/second/second she would be cut into three pieces by the arms of the Man of Steel. (This reminded me of Larry Niven's classic analysis of why Superman can't have sex with a human woman, let alone produce a hybrid offspring, "Man of Steel, Woman of Kleenex.") Scientists, on the other hand, see Hollywood as promulgators of misinformation, a point she illustrated with reference to an anti-vaccination episode of "Eli Stone" and the fact that DNA results on "CSI" and "Bones" are always returned within hours (also illustrating the nitpicking point).

The Science and Entertainment Exchange provides producers of film, television, comic books, video games, novels, etc. with a free way to obtain accurate scientific information early on in a project, and has already worked with major productions including "Bones," "Tron II" (now "Tron Legacy"), and several that she was contractually forbidden to mention.

She told the story of how she met the showrunner for "Bones," and when she told him she was a scientist, "he instantly cringed, flinched, and apologized." She subsequently worked with him on the "Death by Physics" episode of the show.

She pointed out that this is a great time for science and skepticism, with the popularity of current programs like Numb3rs, Bones, Lie to Me, The Mentalist, House, The Big Bang Theory, and, "a fringe case," Fringe (one of the writers of the show is Glen Whitman of the Agoraphilia blog; and for those interested in the glyph code on that show, here's the solution).

Ouellette argued for the importance of this project by pointing out that a factoid about breast cancer which appeared in a soap opera was found to triple the knowledge of that factoid in its viewing audience (based on testing viewers before and after watching the episode), and that these new shows do a good job of humanizing scientists. When debunking messages come from sympathetic characters, that softens them and makes them more persuasive. She suggested that The Mentalist saying that there are no real psychics, or Lie to Me debunking the polygraph, has huge potential impact.

She closed by saying that the success of these popular programs suggests that critical thinking and science placed in an entertaining context do sell, and asking those with a science background who want to be consultants for her project to contact her--and CSI needs new ideas on how to kill people.

In the Q&A, the first questioner said that they don't like when scientists are depicted not acting like scientists--misusing words like "proof" and "theory," and misrepresenting the process of science. Another asked whether she could say anything about science on "Lost"; she said that scientists consulted and commented on the DVD extras about the temporal anomalies and "chronology projection conjecture," and that it's the best-selling TV show on DVD. One questioner asked whether there is any way to do something like this for the news media, as well as for entertainment; she answered that people in the news media need to be paid better (I presume she was referring to print reporters rather than talking heads on television), and those outlets are in their death throes. Another questioner asked why skeptics have to be depicted as dumb in shows with supernatural or paranormal phenomena, rather than showing them change their minds when presented with overwhelming evidence of these things.

Anti-anti-vaccination Panel
Steven Novella, David Gorski, Joe Albietz, Harriet Hall, Michael Goudeau, and Derek Bartholomaus made up the panel to criticize the anti-vaccination movement. Novella began by recounting the Andrew Wakefield case, a study published in Lancet allegedly connecting measles/mumps/rubella (MMR) vaccination with harmful effects in children, which subsequently turned out to be a thoroughly bogus study ("if I can use that word," he said, referring to the Simon Singh lawsuit). But that study caused a decline in MMR vaccination in the UK, and a corresponding leap in news cases of measles, mumps, and rubella. When Novella blogged about this, journalist David Kirby contacted him and argued that thimerosol (sodium ethylmercurithiosalicylate), was the issue. Novella read Kirby's book arguing that thimerosol causes autism, Evidence of Harm, and did 3-4 months of research. (Novella's Skeptical Inquirer article on the subject is here; a reply to Kirby on Novella's blog is here.) He said Kirby's book was a terrible piece of journalism but a good collection of data sources to start with. By 2005 there was strong evidence of no link between thimerosol and autism. Novella's panel intro is now on YouTube here; Dr. Joe Albietz's talk is on YouTube here.

Back in 2002, thimerosol had already been removed from routine vaccine schedules, and Kirby said that autism rates would subsequently plummet to pre-1990 levels. Novella said no, If I'm right it will continue to increase until it hits some ceiling--and the autism rates have continued to rise for the last four years. Kirby moved the goalposts for his prediction out to 2007 and then to 2008, but there is no more room to move them now, said Novella--thimerosol is demonstrably not the cause of autism.

Novella said that the antivax movement has grown as evidence has accumulated against them, spearheaded by promotion by Jenny McCarthy and Generation Rescue.

David Gorski talked about how "I'm not antivaccine" is the biggest lie of the antivaxers. They will say things like (quoting Jenny McCarthy), "I'm not anti-vaccine, I'm pro-safe vaccine. I'm anti-toxin." Examples of people making such statements include Jenny McCarthy, Dr. Jay Gordon, a frequent visitor to Gorski's blog, and J.B. Handley, the founder of Generation Rescue.

He quoted a statement from Jenny McCarthy saying that mercury, the "second worst neurotoxin in history" is injected into children, but noted that she's not so anti-toxin as to avoid injecting the worst neurotoxin, botox, into her face. He also noted that despite claiming not to be anti-vaccine, she has also said, "If I had another child, I wouldn't vaccinate at all. Never, not ever."

Claimed toxins in vaccines include aluminum, ether, and mercury. Generation Rescue claimed in 2005 that autism is a misdiagnosis of mercury poisoning, then they've shifted to being caused by heavy metals, to being caused by toxins, to being caused by too many vaccines, too soon--but it's always about the vaccines.

Gorski suggested the following questions for those who say they are not anti-vaccine, yet are still challenging vaccines in this way:

1. You say you want safer vaccines. By what measure?
2. What toxins would you remove? What's the evidence for toxicity?
3. What evidence would it take to persuade you that vaccinations are safe with respect to the risk of the disease (i.e., using the vaccines saves significantly more lives than not using the vaccines)?

Dr. Joe Albietz then spoke on how every major medical breakthrough and development to save lives pales in comparison to vaccination. This was a powerful talk that I'd like to see turned into a viral vaccination video for YouTube.

Smallpox vaccine has saved over 300 million lives. In 1967, a global eradication campaign was begun, at an estimated cost of $10M-$15M/year over 31 countries. After ten years--in 1979--the disease was officially eradicated at an expense of about $23M/year.

Dr. Albietz presented a list of vaccine-preventable diseases, and noted the number of incidents per year before and after the vaccines. For just the top ten diseases, over 1.1 million lives per year have been saved from disease by vaccination.

He noted that polio and measles are scheduled for eradication. In 2008, the number of cases was 1,652, which amounts to over 5 million cases of paralysis prevented. Measles used to be the second leading cause of infectious disease death, killing 1 million children per year. The goal is to reduce measles cases by 90% by 2010, which will probably be missed.

The anti-vax movement not only affects the lives of children who are not vaccinated, the reduction of the rate of vaccination reduces the herd immunity of the population, making it more likely that even those who are vaccinated will get the disease.

Dr. Harriett Hall spoke on "Two False Alarms," which gave much more detail about Andrew Wakefield and Neil Halsey. She began by talking about Andrew Wakefield's 1998 Lancet paper on MMR vaccines, which used no controls and had an honest conclusion ("we did not prove a link"), but Wakefield called a press conference saying that the MMR vaccine should be stopped and made into separate vaccines--without disclosing that he had just filed a patent for such single vaccines. This resulted in measles again becoming endemic in the UK, Wakefield's study was retracted after problems were found in it, and Wakefield was exposed as unethical. He had been hired by a lawyer to find a link between vaccination and some harm in order to sue drug companies, and was paid 500,000 pounds for the purpose. His study was performed on the children of plaintiffs in the legal case, there was no ethics committee approval, and he didn't disclose his conflicts of interest.

Neal Halsey raised warnings about thimerosol, which contains ethyl mercury. We knew that methyl mercury can cause problems, but not ethyl mrcury. Experiments on adults with amounts 20,000 times higher than in thimerosol in vaccines have caused no symptoms of mercury poisoning. Halsey didn't raise autism as a concern, just mercury poisoning, but two mothers of autistic children who learned of his claims decided, incorrectly, that the symptoms of mercury poisoning were the same as the symptoms of autism. Today 2/3 of the U.S. population incorrectly think that mercury causes autism.

Michael Goudeau, juggler in Lance Burton's Las Vegas show and writer for Penn & Teller's Bullshit!, briefly spoke about his experience as a parent of an autistic child, and pointed out in his closing statement that nobody can hold up a healthy kid and say "Look, my kid got vaccinated and didn't get autism." But maybe, he suggested, the parents of those whose children get measles, mumps, or rubella as a result of the spread of the disease from unvaccinated children can effectively raise that issue. He said that Andrew Wakefield and Jenny McCarthy are assholes, and you shouldn't base your opinions on the science of celebrities (or jugglers).

Derek Bartholomaus spoke about how he decided to try to find the "Jenny McCarthy body count"--the number of preventable deaths and illnesses caused by non-vaccination--as a result of hearing Steven Novella make references to such a body count on the Skeptics Guide to the Universe podcast. He announced his website, jennymccarthybodycount.com, on Twitter and Facebook three months ago, and it has received tremendous traffic as a result of links from the Pharyngula, Bad Astronomy, and Respectful Insolence blogs.

In the Q&A, Hal Bidlack said "my wife died of cancer, and I'm still angry at her surgical oncologist. I understand these people--does calling them stupid help?" Dr. Novella said that Jenny McCarthy needs to be called out on her misinformation, but the rank and file are victims and we have nothing but sympathy for them--our interpretation of the evidence is diametrically opposed. Dr. Gorski said that it's human nature to want to blame someone. A child born with a disability is painful, but they shouldn't be allowed to use that as a shield against criticism--but they do it because it's effective.

Another questioner asked whether Oprah can be made aware that there is a Jenny McCarthy body count to try to put a stop to McCarthy's TV show. Dr. Gorski suggested that giving McCarthy her own show might have been "a woo too far" provoking blowback in the form of criticism of Oprah such as appeared in Newsweek.

One questioner whose sister is a pediatrician in L.A. said she sees the most resistance to vaccination from high-income people in Beverly Hills. Dr. Albietz said you're 23 times more likely to get whooping cough if not vaccinated, and that he sees nonreligious vaccine refusal as the top reason for children not being vaccinated, but others are still not being vaccinated due to poverty and lack of access, which was the reason for TAM7's vaccination drive.

Another questioner asked if anyone had heard of an increase of cases of polio in India due to anti-vaccination superstition. Dr. Novella said that there were rumors of polio vaccine being tainted with AIDS in Nigeria, which resulted in an outbreak of polio due to lack of vaccination. Harriet Hall said that there were antivaxers back at the beginning of the smallpox eradication effort, but it was nothing like the current scale of opposition.

Someone asked whether we're just speaking in an echo chamber, or is someone working to craft a media message. Dr. Albietz pointed out the Rethinking Autism videos, and observed that we should bring the fight to every front that the anti-vaccination movement uses.

Anti-vaccination is being pushed by chiropractors and practitioners of alternative medicine, observed another questioner, and it won't stop until we stop them. How can we do that? Dr. Hall said that she reported a homeopath to the Department of Homeland Security, since he claimed to be making homeopathic smallpox vaccine, which requires access to smallpox. Dr. Gorski said that we're also combatting the view that natural is better, that getting a disease naturally is a better outcome than vaccinating and not getting the disease. Dr. Albietz pointed out that you cannot strengthen your immune system any better than by vaccinating, and that the keyelements of vaccines are natural ingredients. Dr. Hall observed that delaying the vaccine schedule is based on the misguided idea that it will lessen negative impact to immune systems, when in fact vaccinations promote immune response.

In closing, Dr. Gorski said that most antivax parents are probably persuadable, but he fears that the return of vaccine-preventable diseases will be what it takes to persuade them. Dr. Novella said that if anything is going to help mitigate the problem, it is probably going to come from the people in the room.

Joe Nickell on Bigfoot and Aliens
Joe Nickell gave a visual travelogue of photos of Bigfoot-related signs and places in the Pacific northwest, which included all sorts of Bigfoot-related oddities. The Bigfoot Highway, the Bigfoot Museum at Willow Creek, Bigfoot Rafting, Bigfoot Ave., Little Foot Ct., Bigfoot Breakfast, Bigfoot Motel, Bigfoot Crossing signs, Bigfoot Burger, Bigfoot Books (with big selection of books on bigfoot, as expected). He showed murals of Bigfoot, Bigfoot chainsaw sculptures, and Bigfoot statues. A lot of it was tongue-in-cheek, but some was serious and some included religious elements--he observed that some think that Bigfoot is supernatural.

He covered aliens and UFOs in a similar manner, starting with photos of Roswell, the Mac Brazel ranch house, and the famous photo of Jesse Marcel and the pieces of foil, sticks, tape, and rubber. He did an experiment with boxkite-like devices (corner reflectors) on a train attached to a weather balloon, that was shot down to see what the wreckage looked like. He also discussed Alien Autopsy "fakelore" and showed a timeline of alien evolution. Hypnagogic experiences that used to be reported as ghosts or demons are now commonly reported as aliens.

In both the cases of aliens and Bigfoot, he sees them as mythical creatures, and remarked that Bigfoot seems to be used as something like an "eco-messiah." Aliens have also been used in the employ of environmental causes.

In the Q&A, the first question was why there seems to be a rise in alien abduction claims, rather than UFO sightings, and whether this might be related to the rise of camera phones. (If I can reconstruct the reasoning, I think the issue is that there are more people out there with cameras at all times, yet fewer UFO sightings, while if there were really alien spacecraft, you'd expect more successful photographs. But if it's more of a psychological or mythical phenomenon, then perhaps it transforms to fit the evidence.) Nickell responded by observing that alien stories have evolved and continue to change. In my notes I commented that there seems to be a shift in the UFO community from "alien spacecraft" to "another reality" as an explanation of UFOs, and even some creationists have gotten in on the latter sort of view with the claim that UFOs are demonic influences. That view was expressed by Norman Geisler's testimony in the McLean v. Arkansas creationism case back in 1981, and has more recently been propounded by Gary Bates of the Australia-based Creation Ministries International.

That concluded the regular conference programming for Friday, July 10.

Saturday continued with a very special Skeptics Guide to the Universe recording session, Michael Shermer, and Adam Savage, summarized in part four.

The Amazing Meeting 7: Steele, Plait, Lancaster

This is part two of my summary of TAM7, still on Friday, July 10. Part 1 is here, and my coverage of the Science-based Medicine conference begins here.

Sorry for the delay in posting this--it was a combination of other distractions and hoping that Dr. Steele would reply to the email I sent him asking for some details on his slides, without any such luck. Unfortunately, I was manning the SkeptiCamp booth at the back of the room during his talk, which both impaired my ability to take notes and made it impossible for me to read much of anything on his slides. If any readers have better notes or memory, I would be happy to make revisions to correct mistakes or add further detail. (I had wanted to point out a semi-ironic comment that Dr. Steele made before he began, but I couldn't remember exactly what he said and failed to note it.) [UPDATE (March 21, 2010): Now that Randi has officially come out, and I've remembered approximately what was said, I'll note it here--Steele began by saying something about being preceded by "two straight men" (apparently meant in both senses), who were Phil Plait and James Randi.]

Dr. Fintan Steele
Dr. Fintan Steele, a gay (and legally married in Massachusetts) ex-Benedictine monk with a theology degree to accompany his Ph.D. in genetics, spoke on the subject "Personalized Medicine or Personalized Mysticism?", a talk which bore some resemblance to his paper in Future Medicine, "Personalized Medicine: Something Old, Something New" (PDF). He said that he's moved from the monastery and theology to science, and that he (we?) wants to keep them separate, suggesting something along the lines of Stephen Jay Gould's non-overlapping magisteria (NOMA) view, which argues that science and religion are separate domains which do not overlap. It's a view that hardly any advocates of either science or religion hold, and it's hard to see why they should. When religions make empirical claims, that's surely the domain of science, and it's also surely the case that philosophical arguments should be informed by relevant scientific data. The argument in the other direction is, I think, a bit more difficult to make, at least until religion develops methods that are reliable, reproducible, and objectively demonstrable--but at that point it would be science.

He began with a familiar quote from Hippocrates that also appeared in Dr. Val Jones' presentation at the Science-based Medicine conference, "Science begets knowledge, opinion begets ignorance." To which he commented, "but not always." He then gave a Webster's definition of personalized medicine, and said he will argue that this is a mystical rather than a scientific definition.

Dr. Steele proceeded to go through a brief history of medicine, arguing (like in his paper cited above) that personalization of medicine is nothing new, but has been with us since Hippocrates, who used thought that medical treatment was a matter of putting the four humours into proper balance, idiosynkrasia (idio = personal, synkrasia = mixing or blend, or, in the context of the humours, temperament). Galen went on to do "tests" of patients to determine proper treatments, and Paracelsus introduced environmental factors and the concept of proper dosage.

He then briefly talked about the science of DNA and what is being learned as the cost of sequencing becomes cheaper and the volume of data increases. He said that there is "tons of sequence variability" and we're learning about ways that DNA can be "turned on and off." At his current place of employment, the Broad Institute, he said that they have a very large amount of genetic information on servers. He talked about the genome and made reference to a Bligh study (?) and to genome-wide association (GWA) studies. These studies involve genotyping lots of individuals and looking at where they differ. For example, he noted that you might compare the genomes of 10,000 people with Type 2 diabetes to 10,000 people without it, and then look at the differences in order to find areas that are associated with the disease.

The catch of these studies is that the genome information collected is incomplete, relying upon samples of specific single nucleotide polymorphisms (SNPs) within a haplotype block, which Dr. Steele characterized with the analogy of using a single house in the block to stand as a representative sample for the block--the method of finding a difference can tell you that there's a fire in the block, but you still have to go house by house to find the blaze.

He noted that this technique has been successfully used to find genetic correlates to a variety of diseases and conditions, including Crohn's disease, breast cancer susceptibility, coronary disease, prostate cancer, macular degeneration, and schizophrenia. The research has started to fragment diseases into finer-grained categories. We've gone from blood diseases to leukemia vs. lymphoma, to 38 leukemia subtypes and 50+ lymphoma subtypes.

He seemed to be approving so far, but indicated that there is then a line that people cross and draw wrong conclusions. He identified a number of the genetic testing companies, such as Navigenics and 23andme, as culprits. These companies, he said, will tell you something like "Because you have a particular variant x, your risk of disease y goes up by z%. So go eat more vegetables." But, he said, "It's a lie. Reasoning and expectations have gone astray."

He then turned to theology to draw an analogy that I'm afraid completely escaped me. He asked us to conduct a reasoning experiment about constructing an ordered list of things you can find in Las Vegas by moral acceptability, from premarital sex to rape, including bestiality, incest, masturbation, and contraception. Constructing such a list relies upon some kind of underlying principle based on beliefs. He then offered the Roman Catholic Church's ordering, based on the out of print Handbook of Moral Theology (by Anton Koch, volume 2 is online), which gives an ordering of sexual sins based on gravity, and puts masturbation as the very worst, homosexuality less bad, incest less bad still, etc. Why? Because "Sex is primarily for procreation. That's a scientific statement," he said.

I have a couple of problems with his argument so far. First of all, I think his "scientific statement" plays on an equivocation on purpose vs. function. The reason sex exists--its function--is for procreation, but that doesn't make it our primary purpose in having sex. Second, even given that fact, the proposed RCC ordering doesn't follow. Homosexual behavior is no more likely to produce offspring than masturbation, and thus should be equally bad--if that's the only relevant factor, then each act should be ranked based on the probability that offspring will be produced. By the same token, premarital heterosexual sex should be on the good side of the spectrum. Third, probability of procreation is clearly not the only relevant factor in making such an ordering, even if we limit ourselves only to other "scientific statements" such as "people tend to seek pleasure and avoid pain" and "consensual relations are less likely to produce physical or psychological harm than involuntary relations."

He then asked the question where do we get the principles based on beliefs that we use to construct such orderings? He answered that we get them from two places, 1. rational observable scientific thought, and 2. metaphysics. He then said something about science resting on metaphysical claims where I missed the details. I'm not sure if he was asserting that all science rests on certain metaphysical claims (which I think is quite plausible--we tend to assume that there is an objective external world which can be measured, that we're not brains in a vat or solipsistic dreamers), or that the science of the companies he's complaining about are making unwarranted metaphysical claims. I think the latter was more likely his point.

Dr. Steele then asked, "What explains the popularity of these genomics startups? [The view that] DNA is the fundamental part of your being. That's a load of shit." Here again, I think he's made a somewhat ambiguous statement, depending on how one caches out "fundamental"--clearly, our DNA is a very important determining factor in who we are.

He objected that these companies are engaged in hype and overselling, and so is the NIH, in order to allow for continued funding. But, he said, it's based on "a mystical interpretation of genes. Biology is hugely complex and we're just beginning to understand it."

He then offered a diagram with two triangles listing some bullet points or statements, and drew a dividing line between science and mysticism. I was unable to see his diagram or where he drew the line, and I cannot tell from my notes or memory of hearing his talk what he used as his criterion for drawing the line.

Dr. Steele then went on to say that he's not trying to dismiss the genomics studies, but what's more important than the genotypes is what we are learning about pathways of interaction. For example, in the case of diseases that affect vision, what becomes important are things like the photo-tranduction pathway, which is implicated not only in vitreoretinopathy, but a certain type of colon cancer and other diseases. He suggested that medicine will become more about pathways than about individual organs. But this won't be personalized at the level of an individual, but rather on the categories of pathways.

The genomics/personalized medicine language is popular, he suggested, because it's narcissistic. And it costs a lot, so people infer that it must be worth something.

He also said that "it doesn't take a wacko to shovel nonsense"--the press regularly gets it wrong. For example, he said that "there is no gene for kidney disease." He suggested that journalists challenge the scientists promoting personalized medicine to explain how they think it will produce the results they claim.

In the Q&A session, he gave a specific example of an acquaintance, a D.C. lobbyist, who purchased his Navigenics portfolio, which told him he had a low risk of heart disease and glaucoma--but he already had glaucoma. In answer to a question about gene patents, he said that the Broad Institute, which is an offshoot of the Whitehead Institute, doesn't do patents, and that he thinks the problem that gene patents are causing for chip-based assaying of genes is ultimately going to cause them to be thrown out. In response to a question about the ability to tailor drugs specifically based on genetic information, he agreed that yes, this can occur "for certain very rare things," but that "DNA is just a recipe, environmental changes have huge impact. Few diseases are related to just a small number of genes. ... Genes that encode [such things as] drug transport molecules ... will be useful for ... drug dosages."

(Orac commented a bit on Dr. Steele's presentation in his post-TAM summary. A video excerpt of Steele's talk may be found here.)

Phil Plait
Phil Plait spoke briefly about the vaccination drive, gave more thanks to the JREF staff, and had Paul Anagnostopoulos talk about the JREF scholarships. Paul noted that 41 people were attending TAM7 as a result of scholarships, donations for which were at an all-time high despite the economy. He also noted that JREF is offering $10,000 in academic scholarships this year, and encouraged students to apply. (The deadline is rapidly approaching--they must be received by August 1.) Those scholarships are due to a grant from a generous family in Florida.

He then gave up the rest of his time to Robert Lancaster of the Stop Sylvia Browne website.

Robert Lancaster
Robert Lancaster came up to the front of the stage in a wheelchair after being introduced by his friend J.C. He explained that he suffered a stroke last August, and has spent the last 11 months in the hospital and in rehabilitation, and so many of his planned newer sites (Stop John Edward, Stop Benny Hinn, and Stop Peter Popoff) are still in development. He noted that last year he had jokingly referred to Stop Phil Plait at TAM6, and someone registered the domain while he was still speaking.

He said that he planned to talk about strokes and skepticism, and wanted to talk to other skeptics who have had strokes, of whom he talked to only one, Derek Colanduno of the Skepticality podcast, who has made a full recovery. He warned that he suffers from emotional lability, a condition of excessive emotional reactions and mood changes, and that this would explain if he suddenly became a blubbering idiot.

After telling a few stories of his rehabilitation, he gave thanks for the generosity of members of the JREF Forums who have helped him out. He told the story of his first discovering James Randi by seeing him on Johnny Carson's Tonight Show in the 1970s, and "opening a can of skeptical whoopass" on Peter Popoff in 1983. Randi, Lancaster said, had showed him that skepticism can be a form of public service, and that's what he's tried to emulate with his websites.

He first contacted Randi, via email, in 2001 after seeing John Edward on television. He figured Randi was the right guy to deal with Edward, and came across the randi.org website and sent an email, figuring some staff member might read it and give it to Randi. To his surprise, he got a personal response from Randi--which he characterized as "use the search engine, putz." (I'm hoping that weren't Randi's actual words, but Lancaster's feelings about the answer, which was that there were already multiple articles exposing Edward on the JREF website.)

Lancaster then returned to the story of his stroke recovery, and how after his previous wife left him, he found Susan via match.com, and they exchanged photos, email, and phone calls. After they had met in person, he asked her why she hadn't commented on his initial photos--she said they were "scary" because she thought he "was a biker." She concluded that no, "he was a teddy bear." They married five years to the day after their first date, on June 1, 2007. Without her, he said, I would be dead right now, and that without her, his life would not be worth living. He asked her to come on stage with him.

He then told the story of how he came to have his stroke. He said that 15 years ago, he had a bad headache that he should have gone to see a doctor for, but he went to bed, and woke up with the same headache. He went to his doctor's office, but the doctor was out, and the first assistant to take his blood pressure said, "That can't be right," and went to get another. Two more assistants took his blood pressure, were confused, and called the doctor to report. The doctor told him to either drive himself immediately to the emergency room or to let them call an ambulance for him, because his blood pressure was 300/180.

I had been a little queasy and light-headed listening to the references to strokes, for a variety of reasons that include a bit of hypochondria, drinking a cup of coffee, having little for breakfast, and having a bit of a hangover. Having a persistent sinus infection that I'm still fighting today wasn't helpful, and the pain in the left side of my neck (which I now know was lymphadenopathy from that infection) served as creative material for my hypochondria. I ended up having to leave the room and have a seat in the hallway to turn my thoughts to more pleasant subjects.

I waited until I heard applause from inside, and returned to the SkeptiCamp table sans camera, to find that Lancaster was actually still continuing on about various subjects. At some point I believe his wife assisted in cutting it short (he had gone some ways into lunch time), and I ended up still being a bit shaky through lunch.

I ended up losing my camera for the rest of the day, and getting it back from the registration desk the next day (thanks to both whoever turned it in and the gentleman who told me via Twitter that it had been turned in).

(Part three of my TAM7 summary, on Jamy Ian Swiss and James Randi, Jennifer Ouellette, the anti-anti-vax panel, and Joe Nickell, is here.)

Arizona's homeopathic medical board

Dr. Kimball Atwood's presentation at the Science-based Medicine conference included some observations about the overwhelming evidence against homeopathy being a valid or even remotely plausible treatment for anything. During one of the Q&A sessions at that conference, someone made an observation that Arizona is a terrible state for all kinds of quackery, and even has a State Board of Homeopathic Medical Examiners.

The homeopathy board was created in 1982 by a law written and lobbied for by Dr. Harvey Bigelson, a homeopath who was indicted in 1992 by a federal grand jury on 63 counts of Medicare fraud, 44 counts of mail fraud, and eight counts of obstruction of justice. He plea-bargained his way down to three counts and five years of probation, and lost both his medical and homeopathic licenses, making him one of only two homeopaths to lose their licenses by action of the board. He subsequently opened a cancer clinic in Mexico to continue his quackery.

There was an opportunity for Arizona to dispose of its Homeopathy Board in 2006, when the law that created it would have expired under its sunset provisions, but our legislature foolishly renewed it despite overwhelming evidence that it not only gives an unmerited credence to nonsense, but doesn't even do anything to keep criminals from practicing homeopathy. An October 9, 2005 story in the Arizona Republic pointed out several cases of convicted felons from other states permitted to obtain homeopathic licenses and practice in Arizona. It also pointed out that complaints brought against homeopathy board members for malpractice and sexual harassment were simply dismissed:

The homeopathic board has dismissed at least five complaints against its own members over the past five years, including one in which a patient suffered kidney failure after treatment, as well as an alleged incidence of sexual harassment.

The complaint involving kidney failure was lodged against board member Dr. Annemarie Welch in March 2003. The woman who lodged the complaint fell ill after seeking treatment from Welch for an infected blister on her toe. Welch treated the infection with "vitamin C therapy," according to board meeting minutes.

After the woman suffered "acute renal failure," she filed a complaint against Welch with the Arizona Medical Board, which also licenses Welch.

The homeopathic board argued for primary jurisdiction of the Arizona Medical Board complaint against Welch, arguing that she had primarily used homeopathic procedures. Once the homeopathic board had control of the case, it dismissed the complaint.

According to meeting minutes, board members did not believe there was a correlation between the vitamin C therapy and the patient's kidney failure. They also noted that the patient didn't comply with Welch's treatment recommendations. Welch pointed out the Medical Board also found no wrongdoing in its investigation.

That's crazy--the judgment shouldn't have been whether the vitamin C therapy caused the problem, but whether the LACK of a real treatment of the infection caused by the quack treating her with vitamin C caused the kidney failure. The story goes on:

A Phoenix woman lodged a sexual harassment complaint against board member [Dr. Gary] Gordon in May 2001. The woman said he had spontaneously kissed her on the mouth after she stopped to speak with him at his booth at a medical trade show.

The homeopathic board dismissed the woman's complaint because she did not show up to the May 2001 meeting at which her complaint was scheduled to be heard. She apparently had a family emergency and wrote to the board that she could not make it. Board members questioned Gordon about the allegation, which he denied. The woman did show up at the next board meeting and asked to refile her complaint, but board members voted 2-2 against it.

Nice way to uphold ethical standards, there, homeopathy board. And their permissive behavior with regard to conduct appears to extend beyond members of the board to the licensed homeopaths they're supposed to be regulating:

Troubled physicians licensed by the board include Dr. Charles Crosby, who obtained his Arizona homeopathic license in May 2004 despite revealing to the board that he had been ordered to have counseling for a "perceived loss of social inhibition" in his home state of Florida. It later became known that Crosby had been accused of fondling patients and of having a breast fetish. A report on the case in Florida said Crosby had developed "a special technique of manipulating women's breasts to treat pain in other areas of their body."

The suspension of Crosby's license in Florida triggered a inquiry before the Arizona homeopathic board in July. At the meeting, Schwengel, the board president, said he did not find any specific examples that showed Crosby had acted unprofessionally, according to meeting minutes.

Other members expressed concern about Crosby's behavior, but they did not suspend his license, instead giving him until November to undergo an independent mental evaluation to determine if he is competent to practice here.

Board member Gordon defended this action on the grounds that in the U.S. we assume that doctors in trouble who have "paid their debt to society" have been rehabilitated, and that taking away a license is a severe punishment:

"What we look at is, do we want to try and resurrect a troubled physician and keep them under control, or do we want to throw them away and let them dig ditches?" Gordon said. "Once you take a doctor's license away, they don't really have a particular skill that they're qualified to do."

And what are homeopaths qualified to do in Arizona, besides dispense bottles of overpriced water falsely claimed to be medicine? The board's website gives the answer:

The scope of the license includes the practice of acupuncture, chelation, homeopathy, minor surgery, neuromuscular integration, nutrition, orthomolecular therapy and pharmaceutical medicine (see A.R.S. § 32-2901(22)).

The one that jumps out at me the most is "minor surgery." Yikes!

Here's a list of approved continuing education courses for homeopaths in Arizona:

Learn Oxidative Therapy AHIMA/Westbrook 1/22/09 7 hours
Ethics & Boundaries Dr. Jodi Decker Flexible 3 hours
Professional Ethics Dr. Jodi Decker Flexible 4 hours
Lyme-Autism Connection LIA Foundation/CHOICE 6/25/ - 6/28/09 12 hours

The middle two courses on ethics would seem to me, if taught honestly and accurately, to completely undermine the enterprise. Homeopathy is a bogus practice, and I'd think using bogus practices as medical treatment should be near the top of the list of unethical things that health practitioners should avoid. The other two courses sound like the promotion of quackery; oxidative therapy has been a quack treatment for cancer, and the latter is about a link between two conditions, each of which is already surrounded by rampant nonsense, that is being promoted by the "Lyme-Induced Autism Foundation" in advance of supporting research or data. There was some research being done at Columbia University's Lyme and Tick-Borne Diseases Research Center a few years ago by Dr. Brian Fallon about a possible misdiagnosis of some cases of Lyme disease as autism, but that apparently has not demonstrated any connection and there is nothing about autism currently on their website. About.com compares Fallon's description of his research to a press release from the L.I.A. Foundation:

Fallon:

In our work with children who have developed Lyme disease, we have encountered a few children who had developed autistic-like disorders which were eventually also diagnosed as having Lyme Disease due to other concomitant symptoms; when the child received intensive antibiotic therapy, the autistic syndromes dramatically improved and, in some cases, resolved. We hypothesize: a) that a small subpopulation of children with autism in Lyme endemic areas may have an antibiotic responsive disorder due to a spirochete-induced autistic syndrome...

L.I.A. Foundation press release:

New reports indicate up to 90% of children with autism are infected with Lyme disease. With autism at a staggering 1 out of 166 children, parents are questioning this new finding.

Can you tell which organization is using scientific methodology? The L.I.A. Foundation's list of its own activities puts "awareness" and "education" ahead of "research," which is putting the cart before the horse. (Of course, if they did research as a priority, that could cause problems for their chosen acronym--the L.I.A.R. Foundation probably wouldn't get as many donations.)

It should be noted that Welch and Gordon are not on the state homeopathy board today. But next time we have the opportunity, I suggest we Arizonans get rid of this board completely.

UPDATE (February 9, 2011): I recently came across this April 10, 2008 New Times story that shows how Arizona's homeopathic board certification has effectively been an invitation to doctors who've lost their licenses in other states to come to Arizona and become M.D.h.'s.

Science-based medicine conference posts yield new visitors

Looks like the chiropractic post has been referenced at a chiropractic forum, which is generating a fair amount of traffic:

http://www.chiroweb.com/cgi-bin/ubb/dcs_only/forumdisplay.cgi?action=displayprivate&number=4&topic=014324

And the chronic Lyme disease post has been referenced at a Lyme disease forum:

http://www.lymeneteurope.org/forum/viewtopic.php?f=7&t=2623&p=19265

It remains to be seen if this will produce any critical comments, though I noticed that an advocate for chiropractic, "nobs," showed up in the comments at the Science-Based Medicine blog and made a mistaken inference about the conference content--that it was 25% about chiropractic--because he failed to realize that my conference summary had only covered the first four of the six speakers at the time.

Nothing yet from homeopaths that I've noticed.

Science-based medicine conference, part 6: online health and social media, and Q&A

This is the sixth and final part of my summary of the Science-Based Medicine conference at TAM7, which will be followed by a summary of TAM7 itself. Part one, Dr. Steven Novella's introduction, is here. Part two, Dr. David Gorski on cancer quackery, is here. Part three, Dr. Harriet Hall on chiropractic, is here. Part four, Dr. Kimball Atwood on evidence-based medicine and homeopathy, is here. Part five, Dr. Mark Crislip on chronic Lyme disease, is here.

The sixth session speaker was Dr. Val Jones, CEO of BetterHealth, on "Online Health and Social Media: The Good, The Bad, and The Ugly." In this last post of my SBM conference summary, I'll cover her talk as well as the Q&A panel that concluded that day's events.

Personal Story
Dr. Jones began her talk with her personal history--she was raised in Nova Scotia by hippie parents from New York City and grew up on a farm with cows. She said her parents were "moderately weird"--they would ascribe magical powers to yogurt, but they vaccinated their children. She called herself a "shruggie" with respect to complementary and alternative medicine (CAM)--ambivalent about whether there could be anything to it.

She worked with the Ontario March of Dimes, became a doctor, did biophysics and vaccination research at the Mayo Clinic, and earned her M.D. in physical medicine at Columbia. She then worked at Medscape with George Lundberg, editor of JAMA, and created the Clinical Nutrition & Obesity journal there (at Medscape). She was then recruited by RevolutionHealth, an online provider of health information started by Steve Case of America Online. She described it as an "OnStar system for navigating the health care system." She moved to Washington D.C. to take the job, and, as she put it, "entered the Twilight Zone."

Revolution Health
She served as an editorial director and medical reviewer with a staff of 100 doctors across the country, and "couldn't believe the crap that came across [her] desk. Who are these people and why are they so into their colons?"

At one point, an article was submitted from a writer for Alternative Medicine magazine that claimed olive oil cures breast cancer. The study behind the story showed that breast cancer cells in a petri dish, exposed to a chemical found in olive oil, made some kind of genetic change--that was transformed into an alleged cure for breast cancer.

The company developed a health tracker tool, and developers kept adding trackers based on what they thought would be cool, such as a "hot flash tracker." She asked, "Why?" The developers answered, "so they can tell the doctor if a hot flash occurred at 2 or at 3 o'clock!" There was no clinical review of the tracking tools.

Medicine Chest
Another product was developed called Medicine Chest, which allowed people to vote their medicines up or down for how much they like them. "It's not going to be misinformation, it's the wisdom of crowds," the developers said. Not only could users vote on their medicines that were listed, they could add suggestions of their own in free-format text fields. The display of the results on the site didn't distinguish FDA-approved treatments from what people entered in on their own.

The result was that the best treatment for headaches, back pain, strains, etc. was narcotics, followed by marijuana. The best treatment for diabetes (without distinguishing type 1 from type 2) was dog walking.

Dr. Jones compared this to the Citizens' Briefing Book on Obama's change.gov website, where the general public could vote on what they considered to be the most important issues, with the resulting winner being the legalization of marijuana.

Other recommended treatments from the Medicine Chest feature included yogurt for colon cancer, acupuncture for ovarian cysts, herbal treatments for hip fracture, and steroids for cellulitis (which she observed is "very bad and dangerous"). Other similar sites took things to a further extreme, such as Patientslikeme.com, which allowed patients to conduct and report their own clinical trials online. This led to promotion of fish oil to slow the progression of multiple sclerosis and ALS. And beer and dogs as a treatment for lack of motivation.

She cited a quote from Poincare: "Science is facts; just as houses are made of stones, so is science made of facts; but a pile of stones is not a house and a collection of facts is not necessarily science."

She searched the Internet for help understanding the craziness, and came across Orac's Respectful Insolence blog, which she followed for several months. The last straw for her at Revolution Health was when it promoted chelation as a treatment for autism, which could kill a child, and she felt violated her Hippocratic Oath.

Dr. Jones listed a set of psychological factors which lead people to wrong conclusions, of the sort you might find in Kahnemann & Tversky's Judgment Under Uncertainty. On the list was the Hawthorne Effect, which purportedly showed that any change made in a business environment temporarily improves productivity. This effect was named after a study of worker productivity based on data collected after changes in lighting and other conditions at the Hawthorne Works between 1924 and 1932, but subsequent studies have failed to replicate the effect. The original data was recently rediscovered and reanalyzed by Steven Levitt (author of Freakonomics) and John List, with the result that "we find that existing descriptions of supposedly remarkable data patterns prove to be entirely fictional. There are, however, hints of more subtle manifestations of a Hawthorne effect in the original data."

Miscellaneous Slides
She concluded her talk with a few slides with various observations, such as The Onion's "NSF: Science Hard" article and a quote from Surgeon General Rich Carmona that the average American understands medicine at the 4th to 6th grade level. She pointed out that there's a cottage industry of quack cancer treatment providers around the M.D. Anderson cancer center, taking advantage of cancer patients. She criticized the 1994 passage of DSHEA and its signing into law by Bill Clinton, which exempted dietary supplements from FDA approval requirements unless they're found to be harmful. She quoted lots of examples of harm from whatstheharm.net. She recommended Memorial Sloan Kettering's herbal guide, noting that "doesn't work" is the conclusion for most descriptions, and recommended ClinicalTrials.gov for accurate information. And she closed with a quote from Hippocrates: "There are two things, science and opinion; the former begets knowledge, the latter ignorance."

Q&A
There was then a Q&A panel with all speakers. The first questioner came up to note that the CDC of Maine recently sent pediatricians copies of Paul Offit's book, Autism's False Prophets. He also noted that humor of the sort in the "That Mitchell and Webb Look" clip about the homeopathic emergency room was effective, and we need more things like that. Steven Novella responded that we need lots of different things, not any one thing, because AltMed has its marketing down pat.

Another questioner asked if there was a way for social media to work effectively in medicine, to which Dr. Jones responded that MedHealth "has lifeguards in the pool--physicians to moderate." In a later comment, she pointed out that MedHealth has 200-300 doctors who answer questions for free, because the referrals they get as a result more than make up for the [opportunity cost].

Someone else said that the book Snake Oil Science needs to be turned into an easily usable website, and complained that Quackwatch is hard to use and too polemical. Dr. Novella agreed that SBM needs to provide more, better, and more usable information. It would be good to have a place where you can find overviews on topics, allow you to dig as deep into technical detail as you want, and provides a list of sentinel references. (This is essentially what the TalkOrigins Archive provides for the creation/evolution debate, in particular with Mark Isaak's Index of Creationist Claims; the power of providing these kinds of broad and deep archives of reliable material was one of the key points of the talk I gave in June to the American Humanist Association.)

Another questioner asked whether there is anything we can do to get rid of the National Center for Complementary and Alternative Medicine. Dr. Novella said that it is becoming more widely known that NCCAM's Trial to Assess Chelation Therapy, its largest and most expensive trial to date, is loaded with "quacks and criminals" (guilty of insurance fraud and worse) and "totally corrupt," as has been reported by the Associated Press in several good stories. Bioethicist Art Caplan has pointed out that these are unethical experiments on human subjects that would (should?) never be tolerated by NIH. (NCCAM is part of NIH.) NCCAM has spent $1.2 billion $2.5 billion of taxpayer money to date, and produced zero new treatments.

Someone raised the question of what kinds of questions to ask your own doctors to make sure they're giving good advice. Dr. Jones suggested asking, "Do you use UpToDate?", which is a service that searches the world medical literature regularly and provides current data reviewed by 300 full-time reviewers. Dr. Gorski suggested asking whether a doctor follows the NCCN guidelines, which are evidence-based cancer treatment recommendations. Dr. Novella observed that just using Google, a "pull approach," how most people look for medical information online, is highly unreliable because "bad sites are good at looking like good sites." (I'd suggest that a more specialized search engine is a better way--Tim Farley suggested some ways of creating such capabilities at TAM6 last year.) Dr. Hall said that Stephen Barrett's rule of thumb for distinguishing good from bad sites is that "if it's selling something, it's a bad site." I'm not sure how effective that rule is, since even good sites are typically selling something.

Someone raised a problem for use of prior probability, noting that it could have made us miss out on the discovery of lithium as a treatment for bipolar disorder, since it was originally postulated on rather shaky grounds. He gave a second example as SSRIs, which are effective in treating depression, but the original MAOI hypothesis of their operation has been refuted. Dr. Novella responded by saying that first of all, no known mechanism should imply a neutral prior probability (i.e., 0.5). Second, in deciding what to research, it's better to err on the side of the implausible--but not for treatment. He further suggested that lack of mechanism should not be equated with implausibility. Dr. Atwood seconded that there is a difference between lack of mechanism and contravention of a physical law, and made reference to the discussion that he and I had during the break. He gave aspirin as another example of a substance where the mechanism was discovered later than its effectiveness, and expressed doubt about the questioner's story of the discovery of lithium's usefulness.

David Whitlock raised the question of framing, asking why we don't draw the distinction as science-based vs. faith-based medicine. Dr. Novella responded that this would cause more problems than it would solve, at least in the United States, because of the immunities granted to the free exercise of religion. A questioner wondered whether it might at least stop the government from paying for "faith-based" medicine under single payer. (I don't think we're likely to get single payer, and I note that we still have an Office of Faith-Based Programs, so I think this is not a good suggestion.) Dr. Gorski noted that very little CAM is actually religion-based.

A questioner asked how corrupt the Cochrane data is, to which Dr. Atwood replied that the contributions on CAM subjects are unreliable, but reviews of substances are good and Cochrane in general is good. Dr. Novella said that he uses Cochrane to get studies and results, but ignores their conclusions, and pays close attention to authorship. Dr. Hall said that when it comes to meta-analysis, if the result is negative, you should believe it, but if the result is positive, you should look further. Dr. Novella noted that the systematic reviews in Cochrane aren't actually meta-analyses.

And that pretty much wrapped up the day for the Science-based Medicine conference.

If you'd like to continue on to my summary of The Amazing Meeting 7, it begins here.

UPDATE (July 19, 2009): I've been reminded that I neglected to mention one of the more interesting questioners, a massage therapist who stood up and said that he was probably the only "woo practitioner" in the room (though the doctors disagreed that massage therapy really counts as "woo"--and see Dr. Atwood's talk, where he classified massage therapy as having high prior plausibility), who regularly attends CAM conferences. He complimented the speakers and the audience for having a level of displayed intelligence, sophistication, and scientific knowledge that is not seen at those CAM conferences.

Science-based medicine conference, part 5: chronic lyme disease

This is part five of my summary of the Science-Based Medicine conference at TAM7, which will be followed by a summary of TAM7 itself. Part one, Dr. Steven Novella's introduction, is here. Part two, Dr. David Gorski on cancer quackery, is here. Part three, Dr. Harriet Hall on chiropractic, is here. Part four, Dr. Kimball Atwood on evidence-based medicine and homeopathy, is here.

The fifth session speaker was Dr. Mark Crislip, infectious disease specialist and host of the Quackcast podcast, on "Lyme from the IDSA to the ILADS to the ABA."

Like several of the other speakers, Dr. Crislip began with a disclosure of potential conflicts of interest, saying that he had "barely any" and "[hasn't] spoken to a drug rep in 25 years."

He started his talk with a description of Lyme disease. It's caused by a spirochete related to syphilis, that comes in three varieties, European, Asian, and North American. The latter is Borellia burgdorferi, a nasty little organism that lives in ticks, primarily deer ticks. It's transmitted via a tick bite, requiring 36 hours of attachment for transmission, and has grown in prevalence in the northeastern United States with the growth of the deer population. In the northeastern U.S., most ticks have Lyme, while in the northwestern U.S., only 1.3% of ticks have Lyme, because those ticks feed on the blood of a fence-sitting lizard that contains something that kills the spirochetes. (Here, Dr. Crislip joked that despite the presence of numerous fence-sitting lizards in Washington, D.C., the effect doesn't work there.)

North American Lyme disease goes through three stages:

1. skin rash, arthritis
2. spreads to whole body, causes meningitis
3. results in encephalomyelitis and neurological symptoms

There are drugs that work well to treat the disease at all three stages.

However, there are "also people who think they have Lyme but don't," or "post-Lyme disease."

Two Camps
Dr. Crislip identified two groups that have radically different views about Lyme disease:

1. The Infectious Diseases Society of America (IDSA).
2. The International Lme and Associated Diseases Society (ILADS)

The latter says that Lyme is common, hard to diagnose, and "requires infinite antibiotic treatment." The former says nearly the opposite.

The New England Journal of Medicine published a critical appraisal of "chronic Lyme disease" which put the sufferers into four categories:

1. Symptoms of unknown cause, no evidence of B. bergdorferi.
2. Well-defined illness unrelated to B. Bergdorferi (e.g., ringworm).
3. No history of Lyme disease, but blood contains B. Bergdorferi antibodies.
4. Post-Lyme disease syndrome, chronic illness.

The study performed controlled trials of those in category four, and concluded that there is no evidence of B. Bergdorferi persisting beyond treatment, the name "chronic Lyme disease" is a misnomer, and there is no justification for continued antibiotic treatment of such persons.

Dr. Crislip then stated that the two camps present a false dichotomy, but that the truth is closer to the IDSA position. He asked, "is there asymptomatic Lyme?", and answered "yes." 7% of test subjects have asymptomatic seroconversion (show B. Bergdorferi antibodies) in vaccine trial placebo groups. He asked, "can [Lyme be] persistent due to antibiotic resistance?", and answered that there is no good data of that.

He pointed out that Borellia can exist in three forms, the spirochete, a cyst, and an L-shaped form with no cell wall. The cysts appear when the organism is stressed, but isn't found in humans (and is supported in fewer than 25 references in PubMed) and the L-shaped form can be made in the lab but doesn't survive in humans.

Diagnostic Testing
Dr. Crislip said that the standard test for Lyme disease is a two-step process, an ELISA test confirmed with a Western Blot (the same process used for testing for HIV). With classic Lyme disease, this is a very reliable method. It can also be tested with PCR and with antigen assays, and "there is genotypic variation in Lyme that could potentially make the two-step test less sensitive."

There are also labs which perform their own unvalidated tests, such as a lab in Texas that he says "almost always yield[s] positive results." These labs with unvalidated diagnostic tests have caused the CDC and FDA to issue warnings about non-valid Lyme tests.

Dr. Crislip posted a list of alleged symptoms of chronic Lyme disease, which was a very long list including "unexplained hair loss" and "feeling as if you are losing your mind," along with another list of alleged symptoms of chronic candida, and noted that they were quite similar. Using such lists, virtually any symptom is an indicator of these alleged chronic conditions.

The ILADS guidelines go even further, and say such things as:

• The labs are all unreliable, so treat for Lyme even if the test is negative.
• The primary symptom is that the patient thinks they have the condition.
• Physical findings are nonspecific and often normal.
• If the Western blot result is ambiguous, treat it as positive (the opposite of what you do with HIV).
• A comparison to tuberculosis and leprosy provides justification for long-term antibiotic treatment (even though those diseases are biologically dissimilar to Lyme).

In short, the ILADS guidelines provide a nonfalsifiable definition of Lyme disease.

The best trials in the NEJM treated Lyme disease patients with a month of cipro (and?) doxycycline. The "chronic Lyme disease" advocates say that the immune system is damaged with antibiotic use, and then Lyme disease increases as the immune response declines--based on no data.

If you don't have the data, sue
The state of Connecticut passed a bill "giving doctors immunity for giving infinite supplies of antibiotics" to patients purportedly suffering from "chronic Lyme disease." Since the IDSA guidelines are against long-term antibiotic use, the Connecticut Attorney General sued the IDSA. They couldn't afford $250,000 in legal expenses, so they settled the case.

Dr. Crislip concluded by pointing out that the cause of this unsubstantiated syndrome will be promoted by a new film coming out, called "Under Our Skin," which has the tag line "There's no medicine for someone like you." Crislip noted that of the two doctors in the film promoting this illness, one lost his license for diagnosing Lyme disease over the telephone.

(Part six of my conference summary, on online health and social media, and the final Q&A panel session, is here.)