Consider Humanism

The American Humanist Association has launched a huge ad campaign today, which "will include a spot on NBC Dateline on Friday, November 12, as well as other television ads." Fund raising for the campaign is ongoing, and is up to $200K as of today.

The Stiefel Freethought Foundation was the primary sponsor of the Consider Humanism campaign with a $150,000 donation. Another $50,000 was raised from supporters of the American Humanist Association for the launch of this campaign, bringing the total ad buy to $200,000 so far.

You can read more in the press release, watch the AHA's videos on vimeo, by visiting http://www.considerhumanism.org and by clicking the images below for higher resolution PDFs.

Home birth death toll rising in Colorado?

Dr. Amy Tuteur, the Skeptical OB, has a blog post up entitled 'Inexcusable homebirth death toll keeps rising in Colorado.'  Now I'm a big fan of science-based medicine (and of Tuteur's blog), however I have to call foul when it comes to that "rising" part of her post.  Yes, I think it's pretty minor point since the real comparison to consider is the home birth vs. hospital birth mortality rates - but this is a nice opportunity to do some basic stats. Having left a few comments to that effect on her blog, I figured I would summarize them here.

Looks like Boyd Haley is pulling OSR#1 following FDA warnings

Antonio Perez, Chicago Tribune

You may recall a post or two about on this blog about an industrial chelator turned dietary supplement called OSR#1.  It has been used by some to treat autism in children, despite a lack of evidence that it would be safe or effective to do so.  Well after the FDA stepped in recently, CTI Science Inc. appears to be pulling the product until further notice.

Here's an update from Orac at Respectful Insolence which includes part of what appears to be an email from CTI Science president Boyd Haley.  According to that email:

...CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010.

If you were wondering why they're going to wait until July 29, Orac offers up an answer:

My question is this: Why don't Haley and CTI Science simply shut down production and sales now? Why sell OSR#1 for another week? My guess is that the answer is that Haley wants to milk his cash cow for one more week. All the quacks who "prescribe" or recommend OSR#1 to their clients will rush out to buy a boatload of the stuff before Haley cuts off the supply. It's pure profit, because the stuff costs only $0.25 per gram to synthesize. I don't know what Haley sells OSR#1 for wholesale, but Kathleen Seidel points out that certain retailers sell it for $60 to $105 for 30-100 mg capsules of OSR#1. That's right: $20 to $35 a gram--seriously righteous bucks, a markup of up to 14,000%. Given that the Univesity of Kentucky bore the costs of development, and the packaging and filler can't cost all that much...

The (latest) Vaccine Song

This one's making the rounds, so I thought I'd share. Enjoy!

Homeopathic Infertility Treatment

[Thanks to Mike for the link to xkcd]

FDA Warns Maker of Chelation/Antioxidant Pills OSR#1

Antonio Perez, Chicago Tribune

Update:  See this post by Orac on Haley's response to the FDA warning.

I previously wrote a post about a chelating agent marketed as an antioxidant supplement called OSR#1, an unproven product that's been given to children to "treat" autism.  So far it's unclear whether these little pills have any therapeutic effect (seems doubtful) and whether or not they're safe (seems like they're not).

Well the FDA has been paying attention, and recently issued a warning to the maker: CTI Science (previously Chelation Technologies Inc.) run by president and CEO, Boyd Haley.  You can read the full letter from the FDA website.

(No worries - I'll pause here while you read the FDA's letter...)

Journalist Trine Tsouderos of The Chicago Tribune writes...

The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to the autism recovery movement, details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.

The Tribune in January reported that the compound, sold as OSR#1, had been developed to treat mining wastewater, and that it had not undergone rigorous testing to ensure it is safe and effective. The report was part of an investigation into unproven autism therapies offered by health providers who say they can reverse the disorder.

Haley did not reply to repeated requests for an interview Wednesday. An FDA spokeswoman said the agency has not received any communication from Haley, who has 15 working days from the date of the letter to respond.
...

In the interview last year, Haley called the product "a food" that is "totally without toxicity." Haley said the compound had been tested on rats, and a food safety study was conducted on 10 people. Asked to provide documentation of the research, he stopped communicating with the Tribune.

The FDA letter lists side effects recorded during Haley's animal studies: "soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas" and a rapid increase in normal cells contained in the lymph nodes.

Continue reading at the Chicago Tribune...

Ouch!

Over at Boyd Haley's OSR1 twitter feed, there hasn't been much action since their last exposure in the Chicago Tribune. Here's the feed as of June 25...

My BS meter tends to go crazy when someone responds to criticism with something like "the truth is at [my website]". Also, that earlier Chicago Tribune article Haley is referring to is this one, also written by Trine Tsouderos.

For more details on Boyd Haley and the autism community, jump over to Respectful Insolence and read Orac's post, Pumping autistic children full  of an industrial chelator (revisited).

"Gary Null is the Kent Hovind of Alternative Medicine "

If the embedded video above doesn't appear, try here, here or here.

BCA Drops Libel Case Against Singh!!

Update:  According to Ben Goldacre, Singh may go after the BCA to recover his legal costs. You can read more on the case and the remaining need for British libel reform in Goldacre's article in the Guardian.

The British Chiropractic Association (BCA) has dropped is libel case against science journalist Simon Sigh following the recent ruling that Singh could appeal an earlier verdict against him.  Details can be found on the BCA's website here (PDF) via the Sense About Science site here or at the Libel Reform Campaign website here.

BCA V SIMON SINGH - PRESS STATEMENT – 15th APRIL 2010

Having carefully considered its position in the light of the judgment of the Court of Appeal (1st April 2010), the British Chiropractic Association (BCA) has decided to discontinue its libel action against Simon Singh.
...
The BCA takes seriously its duty and responsibilities to members and to chiropractic patients. The BCA has considered seeking leave to take this matter to the Supreme Court and has been advised there are strong grounds for appeal against the Court of Appeal judgment. However, while it was right to bring this claim at the outset, the BCA now feels that the time is right for the matter to draw to a close.

Despite this big victory for Singh, it's only a non-loss for free speech.  Libel laws in the UK still need reform to protect free speech and promote open dialog -- and not just in the UK, but world-wide.

I would have preferred the outcome where Simon won his case on appeal, setting legal grounds for future libel cases against journalists. To learn more about libel law reform in the UK, visit the Sense About Science and The Libel Reform Campaign websites.

Michael Specter on the Dangers of Science Denial

Homeopathy gets throat-punched then drop-kicked by British Parliment

Over in the UK, a big report was released today by the Parlimentary Committee on Science and Technology. In it, homeopathy is basically called out as being ineffective pseudoscience, and bad medicine.  Reading a few of the points made in the report totally made my morning while I was waiting for some computer simulations (and some laundry) to finish!

There's a nice commentary and list of highlights over at Gimpy's Blog:

The Evidence Check on Homeopathy – a merciless punch to its vitalist organs (despite attempts to water down report).

You can also check out the short press release from the Science and Technology Committee

MPS URGE GOVERNMENT TO WITHDRAW NHS FUNDING AND MHRA LICENSING OF HOMEOPATHY.

which also includes a link to the full report.

Further Evidence That Homeopathy Doesn't Work.

Over on the otherside of the pond, a group know as the Merseyside Skeptics Society have launched the 10²³ Campaign to illustrate that homeopathy doesn't work.  Illustrating the fact is simple: gather up groups of skeptics to "overdose" by taking entire bottles of what are basically sugar pills, then spend the next few days laughing as nothing happens to any of them.

Here's the latest from an orchestrated international "overdose event" that took place this past Saturday (30 Jan 2010.)

At 10:23am on January 30th, more than four hundred homeopathy sceptics nationwide took part in a mass homeopathic 'overdose' in protest at Boots' continued endorsement and sale of homeopathic remedies, and to raise public awareness about the fact that homeopathic remedies have nothing in them.

See the links above for more information, or to get your group involved in any future events... I'd imagine there's something happening later this year on October 23rd at 10:23am!

A "Dietary Antioxidant" for kids, or an environmental chelator?

I had made a few posts related to autism a while back, and today came across this article (via Orac's post over at Respectful Insolence).  It's a nice example of bullshit truth in advertising by Kentucky company CTI Science, Inc. ran by Boyd Haley.

I first wondered if the product would be equally marketable were it more appropriately named "Chelator, with Titanium and Iron Rust" or maybe "N¹, N³-bis(2-mercaptoethyl)isophthalamide", instead of "OSR#1", and in the end I decided the answer was probably no.  Why?  So far it looks like a large portion of the intended consumers are parents and caretakers of autistic children...

Haley Autism One 2007 Powerpoint, p. 63 [Source]

More important than the name, I wondered about the truthfulness of the claims on the product website, particularly the scant evidence that the stuff is really safe for children, and of course the story behind this blurb on their FAQ page (as of 19 January 2010):

There is an internet rumor that OSR#1® is an Industrial Chelator. Is this true?

No. OSR#1® as produced by CTI Science is not now and has never been marketed or tested as an environmental or industrial chelator. Nor has OSR#1® been tested in humans as a chelator by CTI Science, and no claims of chelation treatment use are made by CTI Science.

Now, here it's worth noting that CTI Science website also states that OSR#1 was developed in conjunction with...

the University of Kentucky in Lexington which licenses the underlying patent rights to the Company.

(By the way, is it just me, or wouldn't you really like to know what that patent number is?)

According to the articles above, it seems that statement is indeed highly questionable, and the source of that mean ol' "internet rumor" appears to be (gasp!) a University of Kentucky patent -- presumably the very same one mentioned by the CTI Science website?

Reading into this great report and in particular this post (both from 2008), we find...

Prof. Boyd Haley’s new chelator N,N’-bis (2-mercaptoethyl)isophthalamide, or “CT-01” — represented to the FDA as a “new dietary ingredient,” and now marketed as an antioxidant for consumption by autistic children under the trade name “Oxidative Stress Relief” (OSR) — is substantially similar if not identical in its chemical structure to one member of a family of industrial chelators developed by his colleagues at the University of Kentucky, and for which U.S. and international patents were awarded in 2003.

U.S. Patent No. 6,586,600, Multidentate Sulfur-Containing Ligands (issued July 2, 2003) (.pdf) names as its inventors chemists David A. Atwood, Brock S. Howerton and Matthew Matlock of Lexington, Kentucky. David Atwood is a Professor of Chemistry at the University of Kentucky, and Mr. Howerton and Mr. Matlock are graduate students. The rights to the patent are assigned to the University of Kentucky Research Foundation.

More details on the patent issue were posted later here, but it's pretty clear from patent #6586600 mentioned above (presumable the patent licensed to CTI Science, Inc.) that these compounds were intended to be used as environmental chelators.

Looking back at the claim from the website, we see the beauty of good advertising: so far, it looks like CTI Science hasn't technically lied to their consumers here.  You see, while these chemicals were initially patented as environmental chelators, it's technically true that (bold added for emphasis)...

OSR#1® as produced by CTI Science is not now and has never been marketed or tested as an environmental or industrial chelator.

So what do you think? Are they being maybe just a little bit misleading as they try and dodge the association of their product with it's intended role as an environmental chelation agent?

More on Alternative Medicine at the NIH

I just wanted to pass along this piece by Orac over at Respectful Insolence, on what appears to be some pretty sketchy studies looking at Chelation Therapy being done through the National Center for Complementary and Alternative Medicine (which I've mentioned previously).

The full article and some of the links are well worth the read... as a teaser, Orac closes with these remarks (I made some minor corrections and emphasized some text in bold):

If you want to know why NCCAM should be defunded, dismantled, and whatever bits of it that have any value distributed to other Institutes in the NIH, look no further than the offense to science and medical ethics that is TACT [Trial to Assess Chelation Therapy] and the tepid reaction of the OHRP [the NIH's Office for Human Research Protections] to its endangerment of patients. In no other area of human subjects research other than CAM research would a study with so little basis in science and so much evidence against its hypothesis be approved, much less to the tune of $30 million. Too bad powerful supporters of quackery in the legislature (Dan Burton is especially guilty in this case) care far more about proving that their woo works, no matter what, than they care about science or, more importantly, protecting the human subjects who are recruited for CAM studies like TACT from undisclosed risks, harm, or even accurate information about the science (or, more commonly, the lack thereof) behind the treatments being tested.

Ever used a homeopathic remedy?

Surprisingly, you may have - and not even known it.

Some over the counter pills and sprays are homeopathic preparations (that is, some focal ingredient that has been diluted down to only a few molecules - or likely none at all), combined with other filler materials and usually some "vitamins or minerals". While labeled as homeopathic, as required by law, some folks simply overlook these details or fail to grasp what "homeopathic" really means.

I myself used one once - a free sample of Zicam I received as part of a complementary box of toiletries or some sort of product sampler I picked up somewhere (it was a while ago). So why did I try it despite my strong suspicion that it would have no impact on my symptoms? Simple - it's homeopathic! There's nothing in it but some pill-fill and vitamins! What's the harm!?

Well, as it turns out that question sometimes has some unexpected answers. There's actually a site called "What's the Harm?" that is chock full of the dangers of complementary and alternative medicines like homeopathic remedies, though it should be mentioned that anecdotal evidence is not nearly as compelling as the kind of evidence we can get from large well controlled studies or decent statistics based on reliable public health data.

Today, the FDA added more to the list: Zicam Cold Remedy Nasal Gel, Gel Swabs, and Kids Size Swabs. According to reports, Zicam users may suffer anosmia - the inability to percieve smells. A quick google seach of "Zicam FDA" turns up plenty of news briefs on the matter.

So aren't these things regulated by the FDA?? Well, actually, they're hardly regulated like real drugs other remedies.

[T]he FDA treats homeopathic remedies very differently from conventional medicines. Homeopathic products do not need FDA approval before sale; they do have to be proven safe per the Dietary Supplement Health and Education Act of 1994, and they do not have to prove efficacy. Homeopathic remedies do not have to be labeled with an expiration date, and they do not have to undergo finished product testing to verify contents and strength.

Hmmm...

To be fair, the FDA doesn't have any smoking guns - just lots of suggestive anecdotal evidence. Right? Well, there's more to it than that. You see, unlike the shaky foundation of homeopathy, we do have some good science-based understanding of what may be going on here: Too much zinc exposure can reportedly damage nerve function in the nose.

For other details, the FDA press release can be found here, with more details here. For the another perspective, here's what the company website has to say about the matter:

Message to Consumers
June 16, 2009

Matrixx Initiatives confirms that it has received a warning letter from the U.S. Food and Drug Administration about three of its 19 Zicam products, specifically Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs and Zicam Cold Remedy Swabs, Kids Size, based on allegations that their use could cause a temporary or permanent loss of smell, known as anosmia. Zicam Cold Remedy oral products were not included in the letter.

Matrixx Initiatives' primary concern is consumer saftey. Based on the FDA's action, the company has suspended shipments of these products and will reimburse any customer desiring a refund.

However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products. Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data.

The Placebo Effect

Following up on my recent post about recent research into "alternative medicine", I just came across this nice article from skeptic.com about the placebo effect. I found it well worth the read!

What does science say about "alternative medicine"?

According to this AP article, it says that it largely doesn't work. Well, at least not any better than placebo. So if you think that herbal tea helps cure your colds, or that acupuncture can fix your intestinal problems, read no further!!!

While there have been some marginal successes, "it doesn't really work" is largely the take home message of the past decade of research findings coming out of the National Center for Complimentary and Alternative Medicine (NCCAM), an NIH program established in 1991 to investigate the claims of scientifically unproven methods for treating health problems - usually referred to as the more pleasant sounding "alternative medicine" - such as homeopathy, acupuncture, herbal remedies and other common alternatives to science-based medical treatment.

Some may argue that a lot of these efforts were (and continue to be) a waste of time and money. After all, I'm personally not all that thrilled to know that

...the government also is funding studies of purported energy fields, distance healing and other approaches that have little if any biological plausibility or scientific evidence.

Fortunately, not all of these studies dealt with claims that demanded such a stretch of the imagination. Other studies looked into more plausible claims,

Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis. Black cohosh for menopausal hot flashes. Saw palmetto for prostate problems. Shark cartilage for cancer.

and did so using methods that puts these "alternatives" on the same level of comparison with standard science-based medical treatments. Unfortunately (though not surprisingly), almost all of these "treatments" worked no better than placebos.

Whether or not these findings are worth the more than $2billion spent on the projects, I for one am glad to see some of these claims taken seriously, studied, and the findings shared with the public. To elaborate on comments made by NCCAM director Josephine Briggs at the end of the AP article, there's nothing wrong with building sound, science-based knowledge about these mostly ineffective alternatives, and sharing that information with the public so they can make well informed decisions about their health and the health of their families.

It does beg one question though... Can we "have our cake and eat it too" when it comes to reaping the benefits of the placebo effect while at the same time denouncing these treatments as ineffective? Seems like a slippery slope to promote some of these alternatives on this basis, but still an interesting question.

Fear, religion, and bad medicine

I recently came across this post by PZ Myers about a 13 year old Minnesota boy and his family (the Hausers), who are currently in court for the right to refuse chemotherapy to treat the boy's Hodgkin Lymphoma. In doing so, they're refusing an 85% chance of surviving the cancer, in exchange for almost no chance of survival without proper treatment - opting instead for natural remedies such as herbs and vitamins (a decidedly bad form of cancer "treatment"!).

In my usual fashion, I followed up on the blog post and read through a few more articles on the story, like this one, this one, this blog post by Jerry Coyne, and http://www.childrenshealthcare.org/ which chronicles the painful and preventable deaths of a handful of children (mostly from Christian Science families) following the faith-based "treatment" their parents elected to provide them in lieu of real medical treatment.

The consequence of all this (and my reading these stories in the middle of a busy few days of thesis work) was that I completely got wrapped up in the emotional aspects of this and other stories like it, and failed to dig deeper! Was their nemenhah religion really behind all this (in my defense, their website was down when I checked)? What was their experience dealing with his cancer up to this point? A whole slew of other questions a little critical thinking should have brought to mind...

Fortunately, I just saw the post below on the blog Respectful Insolence which points out some of the mistakes which I and others have made in reading into these matters. "Orac" gives very level headed view of the situation, and to me it's a personal reminder that we're all susceptible to loosing our better judgment from time to time.

If you haven't looked over the articles and websites above, I'd suggest giving at least some of them a read before reading this one.

Daniel Hauser and his rejection of chemotherapy: Is religion the driving force or just a convenient excuse?

I'll try to post follow-up links on the Hauser case below, as they become available.