Well, my most recent inspiration for a post is definitely more entertaining than it is cerebral, but I really had to get some thoughts out about this one--it's too good to waste.
A quick caveat before venting:
1) I am not a practitioner of pranic healing, brain yoga, aura imaging, or anything of the sort, but I do not dismiss the idea that some practices in that general category can have healing effects for some people.
2) However, if I happen come off as cynical then I probably have a good reason for it.
While channel surfing a couple days ago, per usual, I came across a typical and friendly infomercial screen. Infomercials are a weak spot for me, so I stopped to check out the latest gadget on display: Shoo!TAG™. They asked questions like, "are you sick of putting harmful and toxic chemicals on your pets to keep bugs away," and "don't you wish there was a safer way to stay bug-free for you and your pets?" Sure, sounds great. I've never looked into it, but those flea and tick topical meds can't be totally safe considering that they are designed to poison pests and stay on the skin for up to a month. These guys, at least in theory, have a better way. With a quick google search of most any product you can get on TV from an 800 number one generally finds at least a couple people posting angrily about how they wasted their money, the refund department doesn't really exist, etc, etc. Just a few mixed reviews here and there, I wanted to go ahead and do a little critical thinking about this "Shoo!TAG™" before it explodes. Apparently, sales are exploding right now, and the makers are unable to meet demand. You must at least give them credit for releasing their product in winter. It was a brilliant move considering flea, tick, and mosquito season was months away with ample time to unload ridiculous amounts of their cutting-edge product before real results could even be seen. Early buyers of Shoo!TAG™ probably stopped their pet's pest medication, attached the tag and found that even after a month there were still no bugs all the while forgetting that it's still cold outside and the infestation won't really begin for another few months. Who is to say that it's not actually working? A look at their website cleared things up a little.
Here's how this device is "working" to keep you bug free:
[Note: One must make some bold (unfounded) scientific assumptions in order to understand the function of this product.]
Shoo!TAG™ utilizes Nature’s energetic principles in combination with physics, quantum physics and advanced computer software technology. The key to Shoo!TAG™ is the three dimensional electromagnetic field embedded in the magnetic strip.
The tag consists of a magnetic strip on a piece of plastic. About as much consideration for quantum physics went into this as it did for a credit card.
Shoo!TAG™ utilizes the power of the bio-energetic field which surrounds all living things to create a frequency barrier which repels targeted pests for up to four months.
Unlike a credit card, which is encoded with a high-coercivity (~4000 Oe) which will last a very long time, it can be assumed that the Shoo!TAG™ was most likely encoded with some low-coercivity to decrease the life of the product. Again, this is an assumption, but it does raise questions.
Shoo!TAG™'s magnetic strip is encoded with beneficial frequencies and resonances and an electromagnetic charge bearing a polarized energy signature, which when introduced into the bio-energetic field of the wearer produces results. Shoo!TAG™ assists the body in altering its external bio-energetic field so as to effectively repel targeted pests.
The company behind Shoo!TAG™, Energetic Solutions, also advertises for "Aura Imaging," which is a sort of crude method of measuring a person's "bio-energetic field." It displays different colored lights surrounding the subject in the picture which can be read to determine the psychological state of the individual. The principle behind "aura imaging" is that everyone's "bio-energetic field" is different. Now, even if one was to buy into that, would it notfundamentally discredit the Shoo!TAG™? To translate the jumbled science jargon: the tag emits resonance frequencies which when combined with one's own frequencies being emitted, will produce a field of a frequency"known to disrupt insect behavior."
Various insects and pests react to frequencies. These frequencies are introduced into the bio-energetic field of the wearer. These specific frequencies and resonances have proven to disturb and repel the targeted pests.
Studies have shown that insect behavior can indeed be modified through the application of an electromagnetic field of specific frequency and amplitude ranges. Problem: The Shoo!TAG™ FAQ says that frequencies emitted are in the neighborhood of Schumann Waves, which are very low frequency (below 100Hz). In a study with drosophila, Watson et al. found an inverse relationship between frequency and amplitude in disruption of insect behavior by an electric field. According to the study, a wave frequency in the range of the Shoo!TAG™ would require an amplitude upwards of 500kV. Good luck getting trying to get that to emanate from a magnetic strip.
(Bold text was quoted directly from http://www.shootag.com/.)
The creaters of Shoo!TAG™ hail from the city where I live, Austin, TX, and we're not short of metaphysics and Eastern healing enthusiasts here. Don't get me wrong, I love Austin. We do get our "Keep Austin Weird" motto for a reason though. The company behind the tag is Energetic Solutions. Their website has no mainsteam or conventional product or service to offer, specializing in pranic healing, feng shui, meditation, and other healing services such as aura imaging and infrared therapy. Many energy medicine products have been the modern day snake oil but many have provided at least some benefit to their practitioners. It is important that people take a real look at this product and others like it before they think they have some miracle cure. The average person viewing the Shoo!TAG™ website, lacking more advanced scientific knowledge, would without a doubt be highly impressed by the descriptions given, even if he or she didn't understand them, and there is no way of knowing of any connection between Shoo!TAG™ and energy healing. In response to an email requesting trial data or details about the product, this is what I received verbatim:
Thank you for your interest in Shoo!TAG. Your questions are excellent. Youan go to our shootag.com for some of our science explanations. We have had alot of companies wanting to know how we did it. The million dollar question!
If you would like to sign a confidentiality agreement and come visit with us, we will consider answering your questions. We do have a patent pending and have to be very careful. However, if you would be interested in doing a trial or working on some of our science applications (depending what department you are in) we would be very interested.
Please let me know if there is more we can help you with.
Melissa Rogers
Co-Founder, CEO
Energetic Solutions, Ltd
So they dodged the question and offered me a job. I'm not sure if that's a good or bad sign... I might just have to pay them a visit and sign that confidentiality agreement.
Thursday, May 14, 2009
Wednesday, May 6, 2009
Loose Ends of the Sequenom Blunder
"Based on the results from the total study samples, including samples as early as 8 weeks of pregnancy, the Sequenom SEQureDx RNA-based technology demonstrated a 100% positive predictive value (PPV) and a 99.9% negative predictive value (NPV). The SEQureDx technology achieved a better than 99% detection rate, with less than a 1% false positive rate."
-- Reuters
This is just a short follow up to my previous post, "Promising Discoveries and Tweaked Results." Upon further investigation of Sequenom, a Reuters report was released in January in response to test results released by Sequenom on SEQureDx (shown above). Food for thought: clinical trials using free fetal DNA as an aneuploidy detection method released just a year prior to those of Sequenom posted a modest, yet very respectable true positive detection rate of 66.7% and false positive rate at only 1.8%. Even these results exceeded those of current detection methods. Considering the overly prodigious results posted by Sequenom on January 28th, it's really no surprise that even the most informed investors bought into the Sequenom hype. I believe it's really up for grabs now. The technology behind SEQureDx is sound--I really believe that. From analysis of the data, I do not believe that true positive and false negative percentages should be in the range of that reported in January, but if accurate results had been printed, I really think that they would have shown a significant increase over traditional methods. If Sequenom can make it through the chaos of all of these class action lawsuits and maintain enough capital to continue with their current clinical trials, success is all but guaranteed. Currently trading at an ultra low after the decimating news on April 30th, SQNM just could be the ultimate steal. Take it with a grain of salt, but keep an eye on SQNM.
-- Reuters
This is just a short follow up to my previous post, "Promising Discoveries and Tweaked Results." Upon further investigation of Sequenom, a Reuters report was released in January in response to test results released by Sequenom on SEQureDx (shown above). Food for thought: clinical trials using free fetal DNA as an aneuploidy detection method released just a year prior to those of Sequenom posted a modest, yet very respectable true positive detection rate of 66.7% and false positive rate at only 1.8%. Even these results exceeded those of current detection methods. Considering the overly prodigious results posted by Sequenom on January 28th, it's really no surprise that even the most informed investors bought into the Sequenom hype. I believe it's really up for grabs now. The technology behind SEQureDx is sound--I really believe that. From analysis of the data, I do not believe that true positive and false negative percentages should be in the range of that reported in January, but if accurate results had been printed, I really think that they would have shown a significant increase over traditional methods. If Sequenom can make it through the chaos of all of these class action lawsuits and maintain enough capital to continue with their current clinical trials, success is all but guaranteed. Currently trading at an ultra low after the decimating news on April 30th, SQNM just could be the ultimate steal. Take it with a grain of salt, but keep an eye on SQNM.
Tuesday, May 5, 2009
Provenge & Dendreon: Analysis of Authenticity
While reading about some recent clinical trials this morning, something really caught my eye. Dendreon (DNDN) has been developing a novel immunotherapy treatment for prostate cancer over the past few years, and recent data has led many to believe that FDA approval will now occur sometime in 2010. In the wake of recent events at Sequenom, which I covered in my last post, I thought a critical analysis of what's currently going down at Dendreon would be appropriate.
The Claim
First of all, Dendreon's data on the drug, which has been named Provenge, looks solid. And I don't mean SEQureDX by Sequenom solid, I mean solid. Here's the rundown on how the stuff is made and how it should work. Previous immune response based treatments using interferon and even microbe-based therapy have been fairly successful, but less specific and less potent than we would prefer that it be. Tumors, for a variety of reasons I won't cover, have a refined ability to hide their presence from an immune response. Researchers at Dendreon analyzed a range of antigen presenting cells (APC) and chose dendritic cells (DC) to work with, because of their status as potent antigen presenters and their ability to initiate anti-tumor responses in both naive and memory T-cells. They then chose prostatic acid phosphatase (PAP) as the prime target for the drug because of its presence in 95% of prostatic carcinomas and lack of expression in other tissues. Provenge, technically named APC8015 or Sipuleucel-T, is created by first fusing human PAP by its carboxy terminus to the amino terminus of human GM-CSF. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) is a potent APC stimulating factor, specifically targeting DC's. This fusion protein, called PA2024, is then used to treat CD54-positive white cells isolated from an individual patient via leukapheresis. Reintroduction of these primed APC's through Dendreon's nifty "proprietary antigen delivery cassettes" is then performed over three vaccinations. In recent studies, a combination therapy of APC8015 and bevacizumab has been tested. Bevacizumab is a vascular epithelial growth factor (VEGF) inhibitor, and VEGF, accordingly, is an inhibitor of DC's. Phase III trial data revealed today showed Sipuleucel-T extended median survival 4.1 months and three year survival rates by 38%. While it is no cure, it is a groundbreaking discovery that could soon be a practical solution to consider before having to settle for the dangerous, unpleasant, and cytotoxic option of chemotherapy.
The Controversy
Late last Friday eight members of high level management at Dendreon dumped 500,000 shares while prices were soaring into their mid twenties. This includes President and CEO Mitchell Gold, who unloaded 250,000 of his own. On one hand, this move isn't all that surprising. Most of the shares were options or company stock grants which had a listed purchase price of anywhere between $2.00 and $12.00, with most being near $5. This was a prime opportunity for these insiders to cash in on these securities and become instant millionaires. Doesn't sound like a bad deal to me! On the other hand, FDA approval seems to draw closer and more assured each day. If and when this treatment is approved, it will become the first therapeutic cancer vaccine ever. Not only that, but APC8015 also begins our quest for personalized medicine which I believe is the next breakthrough in human medicine. This said, analysts are calling DNDN undervalued at the moment, projecting its worth in the $30 range and some suggesting a target high upwards of $40. If I were an insider at Dendreon, I'm not sure I would have cashed in this early. Call me greedy, but with a blockbuster potential treatment about to come out of the pipeline, I think I'd hold on for a bit. I'm desperately hoping that they don't something we don't know. I don't want another scar like Sequenom's on this promising industry.
The Claim
First of all, Dendreon's data on the drug, which has been named Provenge, looks solid. And I don't mean SEQureDX by Sequenom solid, I mean solid. Here's the rundown on how the stuff is made and how it should work. Previous immune response based treatments using interferon and even microbe-based therapy have been fairly successful, but less specific and less potent than we would prefer that it be. Tumors, for a variety of reasons I won't cover, have a refined ability to hide their presence from an immune response. Researchers at Dendreon analyzed a range of antigen presenting cells (APC) and chose dendritic cells (DC) to work with, because of their status as potent antigen presenters and their ability to initiate anti-tumor responses in both naive and memory T-cells. They then chose prostatic acid phosphatase (PAP) as the prime target for the drug because of its presence in 95% of prostatic carcinomas and lack of expression in other tissues. Provenge, technically named APC8015 or Sipuleucel-T, is created by first fusing human PAP by its carboxy terminus to the amino terminus of human GM-CSF. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) is a potent APC stimulating factor, specifically targeting DC's. This fusion protein, called PA2024, is then used to treat CD54-positive white cells isolated from an individual patient via leukapheresis. Reintroduction of these primed APC's through Dendreon's nifty "proprietary antigen delivery cassettes" is then performed over three vaccinations. In recent studies, a combination therapy of APC8015 and bevacizumab has been tested. Bevacizumab is a vascular epithelial growth factor (VEGF) inhibitor, and VEGF, accordingly, is an inhibitor of DC's. Phase III trial data revealed today showed Sipuleucel-T extended median survival 4.1 months and three year survival rates by 38%. While it is no cure, it is a groundbreaking discovery that could soon be a practical solution to consider before having to settle for the dangerous, unpleasant, and cytotoxic option of chemotherapy.
The Controversy
Late last Friday eight members of high level management at Dendreon dumped 500,000 shares while prices were soaring into their mid twenties. This includes President and CEO Mitchell Gold, who unloaded 250,000 of his own. On one hand, this move isn't all that surprising. Most of the shares were options or company stock grants which had a listed purchase price of anywhere between $2.00 and $12.00, with most being near $5. This was a prime opportunity for these insiders to cash in on these securities and become instant millionaires. Doesn't sound like a bad deal to me! On the other hand, FDA approval seems to draw closer and more assured each day. If and when this treatment is approved, it will become the first therapeutic cancer vaccine ever. Not only that, but APC8015 also begins our quest for personalized medicine which I believe is the next breakthrough in human medicine. This said, analysts are calling DNDN undervalued at the moment, projecting its worth in the $30 range and some suggesting a target high upwards of $40. If I were an insider at Dendreon, I'm not sure I would have cashed in this early. Call me greedy, but with a blockbuster potential treatment about to come out of the pipeline, I think I'd hold on for a bit. I'm desperately hoping that they don't something we don't know. I don't want another scar like Sequenom's on this promising industry.
Sunday, May 3, 2009
Promising Discoveries and Tweaked Results
This post will come in two parts. Mostly because I really would like to focus on the good in Sequenom's promising new discoveries in prenatal testing, but it's also important to see what happens when the self-interest of researchers, whether it be a few individuals or (god forbid) a company conspiracy, throws a wrench in the mix.
New Discoveries in Prenatal Testing
Aneuploidy in a developing fetus causes a wide variety of genetic disorders including the more common and well known trisomy 21, or down syndrome. Current testing for chromosomal disorders are limited to amniocentesis and chorionic villus sampling which are both invasive techniques requiring a puncture and removal of placental tissue or fluid. Data on the risks of these procedures seems random and inconclusive with associated miscarriage rate at anywhere between 1 in 200 and 1 in 1600. The non-specificity of this data is fairly surprising. You'd think that there would have been more conclusive studies if for no other reason than to calm the fears of mothers who are most likely already extremely concerned anyways--I'm pretty sure that allowing doctors to probe one's placenta to determine any genetic defects of the fetus constitutes a concerned mother. New methods as described by Dhallan et al are non-invasive and have been shown to be more accurate than current methods, which post a true positive detection rate of 64-94% and false positive rate of 5%. The idea behind the procedure is the analysis of free fetal DNA or RNA within maternal plasma. Sure, the idea is simple enough and appears to be a promising method, but up to this point, isolation of fetal genetic material from from the mother has proven to be fairly difficult. Considering the obvious similarities from mother to offspring, how does one go about this isolation? The answer: You don't! Analysis of the human genome has shown a trend in certain alleles to have single-nucleotide polymorphisms (SNP's) between individuals. By locating a few homozygous single-nucleotide polymorphisms between maternal and paternal DNA, a signal for fetal DNA has been generated, which will be heterozygous for the polymorphic alleles. One can quantify fetal DNA levels by merely looking at the proportion of DNA containing the parental polymorphism to maternal homozygous DNA. What's so convenient about this method is that a specific locus doesn't have to be targeted. SNP's just need to be located on the chromosome where we are trying to detect the aneuploidy. For example, a trisomy 21 indicator would be abnormally high ratios of the unique fetal allele signal to the combined mother and fetal allele signal quantified by SNP's on chromosome 21. The 60 person study conducted posted improved results from the traditional karyotyping methods with a true positive detection of 66.7% and false positives at only 1.8%. This initial study by Dhallan et al seems airtight. It's not perfect, but it is certainly an improvement from current methods and doesn't carry any of the associated risks to the fetus. This is where self-interest unfortunately starts to tear things apart. Sequenom is currently developing a modified version of the test called SEQureDX, which uses fetal RNA instead of DNA. Their company profile looks, or should I say looked, solid, and they have a few promising genetic tests in the pipeline. But when big money gets involved, funny things start happening...
Human Nature Delays Medical Advances
With investor sentiment high and stock prices sailing, it seems one or a few unscrupulous members of the R&D team decided to get a little creative with their results. I hope they at least got some kicks from tweaking their numbers, because whoever it was is likely out of work now. Management doesn't take kindly to employees who bring about class action lawsuits to the company. Oh and lest we forget Sequenom (SQNM) stock dropped $11 to under $4 a share literally overnight. I don't know whether to feel bad for or laugh at the authors of recent articles urging us to hop on the Sequenom bandwagon. Sure would have been one hell of a short though...
Sure, screwing your investors is bad enough, but the content of the issue raises moral questions outside the realm of the marketplace. By falsifying this type of data, researchers at sequenom have delayed the release of a service to the public that could vastly change prenatal testing procedures for the better. I'm not quite sure of the specific details of the data modified. I wasn't able to find the actual publication, most likely because they pulled it from print. Manipulation of data in any kind is not only unethical, it's unacceptable. This makes me question the integrity of an entire industry. Why can't we use our best judgement in these situations? Why do we work directly against the greater good? Money. Notoriety. Self-interest. Sequenom was on their way to releasing a successful test which would have certainly increased revenues and provided mothers access to a new, revolutionary, and safe test for their unborn child. Where does that leave us now? Mothers must continue to face the risks associated with current testing as Sequenom starts from square one, sifting through data from all of their current projects in an attempt to regain the trust of the public. At least in my eye, this casts a dark shadow over what I would like to believe is an industry working to improve our lives.
New Discoveries in Prenatal Testing
Aneuploidy in a developing fetus causes a wide variety of genetic disorders including the more common and well known trisomy 21, or down syndrome. Current testing for chromosomal disorders are limited to amniocentesis and chorionic villus sampling which are both invasive techniques requiring a puncture and removal of placental tissue or fluid. Data on the risks of these procedures seems random and inconclusive with associated miscarriage rate at anywhere between 1 in 200 and 1 in 1600. The non-specificity of this data is fairly surprising. You'd think that there would have been more conclusive studies if for no other reason than to calm the fears of mothers who are most likely already extremely concerned anyways--I'm pretty sure that allowing doctors to probe one's placenta to determine any genetic defects of the fetus constitutes a concerned mother. New methods as described by Dhallan et al are non-invasive and have been shown to be more accurate than current methods, which post a true positive detection rate of 64-94% and false positive rate of 5%. The idea behind the procedure is the analysis of free fetal DNA or RNA within maternal plasma. Sure, the idea is simple enough and appears to be a promising method, but up to this point, isolation of fetal genetic material from from the mother has proven to be fairly difficult. Considering the obvious similarities from mother to offspring, how does one go about this isolation? The answer: You don't! Analysis of the human genome has shown a trend in certain alleles to have single-nucleotide polymorphisms (SNP's) between individuals. By locating a few homozygous single-nucleotide polymorphisms between maternal and paternal DNA, a signal for fetal DNA has been generated, which will be heterozygous for the polymorphic alleles. One can quantify fetal DNA levels by merely looking at the proportion of DNA containing the parental polymorphism to maternal homozygous DNA. What's so convenient about this method is that a specific locus doesn't have to be targeted. SNP's just need to be located on the chromosome where we are trying to detect the aneuploidy. For example, a trisomy 21 indicator would be abnormally high ratios of the unique fetal allele signal to the combined mother and fetal allele signal quantified by SNP's on chromosome 21. The 60 person study conducted posted improved results from the traditional karyotyping methods with a true positive detection of 66.7% and false positives at only 1.8%. This initial study by Dhallan et al seems airtight. It's not perfect, but it is certainly an improvement from current methods and doesn't carry any of the associated risks to the fetus. This is where self-interest unfortunately starts to tear things apart. Sequenom is currently developing a modified version of the test called SEQureDX, which uses fetal RNA instead of DNA. Their company profile looks, or should I say looked, solid, and they have a few promising genetic tests in the pipeline. But when big money gets involved, funny things start happening...
Human Nature Delays Medical Advances
With investor sentiment high and stock prices sailing, it seems one or a few unscrupulous members of the R&D team decided to get a little creative with their results. I hope they at least got some kicks from tweaking their numbers, because whoever it was is likely out of work now. Management doesn't take kindly to employees who bring about class action lawsuits to the company. Oh and lest we forget Sequenom (SQNM) stock dropped $11 to under $4 a share literally overnight. I don't know whether to feel bad for or laugh at the authors of recent articles urging us to hop on the Sequenom bandwagon. Sure would have been one hell of a short though...
Sure, screwing your investors is bad enough, but the content of the issue raises moral questions outside the realm of the marketplace. By falsifying this type of data, researchers at sequenom have delayed the release of a service to the public that could vastly change prenatal testing procedures for the better. I'm not quite sure of the specific details of the data modified. I wasn't able to find the actual publication, most likely because they pulled it from print. Manipulation of data in any kind is not only unethical, it's unacceptable. This makes me question the integrity of an entire industry. Why can't we use our best judgement in these situations? Why do we work directly against the greater good? Money. Notoriety. Self-interest. Sequenom was on their way to releasing a successful test which would have certainly increased revenues and provided mothers access to a new, revolutionary, and safe test for their unborn child. Where does that leave us now? Mothers must continue to face the risks associated with current testing as Sequenom starts from square one, sifting through data from all of their current projects in an attempt to regain the trust of the public. At least in my eye, this casts a dark shadow over what I would like to believe is an industry working to improve our lives.
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