After yesterday's lovefest that really did go to my head. Really, when I wrote it I wasn't trolling for praise, although in retrospect it now does kind of look that way to me. I was simply expressing amazement that anyone would listen to a pseudonymous (although not really anonymous anymore) blogger. Fortunately for my ego, which threatens to expand until it pops like an overinflated balloon, there are are readers who aren't all that impressed by me. Heck, there's even a whole blog, every blogger of which really, really detests me. (I leave it as an exercise to the reader to guess to which blog I'm referring.) Elsewhere, one reader in particular, whom I'll just call T, really, really doesn't like me:
Speaking of your articles on the Cherrix case, you my friend are a bad bad man....I hope you realize that by lying about the fact that natural medicine actually helps people, you are causing their premature death or unnecessary suffering. In case you can't imagine it, people actually die prematurely because they don't try whatever it takes to survive. They might read your article, then when they get sick, might tend to ignore something that will certainly help them. The medical world should be looking into EVERY method to do what is best for the patient, not what is best for the doctor's wallet. How can a person look themselves in the mirror when they lie to people on such a large scale, and about something so serious as llife or death. Dr Smith, Cherrix doctor, is a man of integrity. Unlike yourself. Sure he is making money, but he is also making sure that EVERY possible method is being carefully thought of in order to help the patient as much as possible. Who are you to ignore the results of the doctor's work? He is getting results, as was Hoxsey, and many other men with integrity who have been labeled "quack"....I have seen behavior like this before, in grade school. Remember when in 3rd grade if someone didn't like you, they would make up stories about you and make up very hurtful rumours to discredit you? Well, someday including me, we will all be judged about the things we did to others that wasn't right (maybe not on this planet)....For example, people who misled others into believing lies, and causing their premature death. Sort of like you do in your article. Better be careful also, because alot of people are painfully aware that you are obviously taking bribes from someone in the medical industry. Why else would you publish lies about something that may actually help someone live longer? HORRIBLE
My response, which is uncharacteristically brief, is below:
I have to wonder if T has actually read my posts on Abraham Cherrix. On the one hand, I was very conflicted about whether the state should have the power to force Cherrix to undergo science-based medical therapy instead of quackery (and, yes, T, the Hoxsey therapy is quackery, period), given Cherrix's age and relative proximity to the being legally recognized as an adult. (He was 15 when diagnosed and turned 16 not long after he opted for woo.) I also explained in very great detail why the Hoxsey therapy is quackery two years ago.
Also, I never called Dr. Arnold Smith a "quack." Not once. I called him wrong and characterized his immunotherapy as "dubious" and not validated by science, both characterizations being true. However, he does use radiation therapy, which is an accepted science-based therapy of cancer. He just uses it in what is not the most effective way, preferring "low dose" when high dose is indicated and not coupling it with chemotherapy when indicated. In fact, in retrospect, I'm rather glad that Cherrix found Dr. Smith. Given that he was apparently bound and determined to use "alternative" non-science-based methods to treat his recurrent lymphoma, I'd much rather he be treated by Dr. Smith than using the Hoxsey therapy in some quack clinic in Tijuana. After all, at least radiation therapy does have a measurable effect on tumors. Remember, Abraham had big tumorous lymph nodes growing in his neck which, if allowed to grow unchecked, would have obstructed his trachea (and would have slowly strangled him) or and his esophagus (which would have prevented him from eating, necessitating a gastrostomy tube placed into his stomach to feed him). Dr. Smith's radiation shrank those tumors. In any case, both The Cheerful Oncologist and I explained why Dr. Smith's treatment is highly unlikely to result in a cure, and if it does it would have been the radiation, not the "immunotherapy" woo that Dr. Smith adds to the radiation that did it. There's a small chance that it might, but only very small. Abraham is in remission now, at least as far as can be told, but I do not hold much hope that his cancer will not return. For his sake I hope it won't, even though I know he's going to represent himself as a poster boy for the alleged efficacy of "alternative" cancer treatments. He's not.
As for the allegation that I'm a bad, bad man, well, I leave that to my friends, families, patients, and readers to judge. In actuality, I'm just a man. Just like every other man or woman, I've done good things and bad things in my life. As the middle third of my life flies by and I find myself fast approaching its last third, I can only hope that by the end the good I will have done will outweigh the bad by a hefty margin. That's all anyone can hope for, really.
ADDENDUM: It's funny that T should mention Abraham Cherrix last night. There's actually some news about him that I just saw this morning. More on that later, probably on Monday.
They really, really don't understand the nature of science, and what it means for experimental results to be vetted through the peer review of the scientific community. If Hoxley was really "getting results," his therapy would be mainstreamed. This isn't about Orac personally: we're talking the bulk of the community of experts. Clearly, Hoxley's results fail to meet the rigorous criteria necessary. Individual "success stories" are not enough.
Instead of accepting this, 'T' simply reframes the situation into being like bickering 3rd graders trying to one-up each other. Science isn't about fact-finding: you see, it's all about social status and ego-gratification. That explanation comes from familiar territory, and feels more comfortable than that science-y stuff.
Projection much?
You're no evil man. In the worst case you're an evil computer.
Orac, Do you have any thoughts on this?
http://www.fdalegislativewatch.com/2008/09/digital-mammogr.html#more
Digital Mammography Firms Decry Clinical Trial Provisions In Draft Guidance
Digital mammography systems are on the verge of being downclassified to 510(k) status, but imaging firms say the clinical trial requirements proposed in FDA's draft "special controls" guidance for the systems are costly, unnecessary and overly burdensome.
Full-field digital mammography (FFDM) systems capture full digital x-ray images of the breast, and offer an alternative diagnostic and screening tool to conventional film screen mammography.
FFDM systems may include software, digital image receptors, acquisition workstations and signal analysis programs. Other types of mammographic x-ray producing equipment, such as x-ray generators or breast compression systems, are already regulated as Class II devices requiring only 510(k) clearance before going to market.
Two years after an FDA radiological devices advisory panel unanimously recommended moving the digital systems to the lower-risk category, FDA on May 30 issued a proposed reclassification rule and draft special controls guidance.
The advisory panel based its decision on the results of a large clinical trial showing no difference between digital and film mammography in detecting breast cancer in the general population, and a potential benefit for digital mammography in women with dense breasts or women under 50.
The Digital Mammographic Imaging Screening Trial (DMIST) ultimately enrolled nearly 50,000 women and tested four different digital mammography systems.
FDA says it finally understands the devices well enough to develop appropriate special controls to mitigate foreseeable risks.
While other imaging systems have long been regulated as Class II devices, extra care is required with breast mammography, FDA says, because the technology is used to screen the broader population for cancer, not just to diagnose suspected disease.
When digital systems first emerged, "there were a lot of questions of whether or not cancers were going to be missed, or whether there would be more work-up of the patients," Kyle Myers of FDA's Office of Science and Engineering Laboratories said in an interview.
"We make recommendations that all women over 50 get screened," she said. "We're talking about a lot of women every year, and that's why our concern was high."
Once the rule and guidance are finalized, digital mammography systems will be able to enter the market via the less onerous 510(k) pathway versus the PMA process - though they will have to adhere to the special controls outlined in the guidance. Comments on both documents were due by Aug. 28.
Clinical Trial Requirements Come As A Shock
Device firms agree that downclassification is long overdue, but some of the clinical study recommendations in the draft guidance caught companies by surprise.
According to FDA, the main risks identified with FFDM systems are electrical hazards, corrupted or non-diagnostic images, incorrect patient positioning, excessive x-ray exposure, excessive breast compression and infection or skin irritation.
Most risks can be mitigated with electrical safety evaluation, bench or animal testing and product labeling, but in some cases, more robust clinical data will be needed, FDA says.
A 510(k) submission will probably require clinical data if a system has a different indication than the marketed device it is being compared to, or a dissimilar design or technology, the guidance states.
A features analysis, performed by certified radiologists using both digital and film systems, and including stress testing on some of the most challenging patients, may substitute for a larger clinical trial, the guidance says.
But FDA may still recommend "multi-reader, multi-case" studies when the sensitivity and specificity of a new system is in doubt.
These studies "have no role in a 510(k) application given the results included with previous PMA applications for FFDM systems" and the results of DMIST, the Medical Imaging and Technology Alliance (MITA) writes in Aug. 28 comments.
Additional clinical trials were never discussed or recommended by the FDA advisory panel, adds x-ray technology firm Bioptics in Aug. 25 comments.
The American College of Radiology says the guidance could discourage competition and innovation in the industry. Also, the suggested features analysis and clinical studies would unnecessarily expose patients to double doses of radiation to compare digital and film images, ACR argues.
ACR wants FDA to clarify that multi-reader, multi-case studies will be required only for devices that are not substantially equivalent to predicate devices, such as for the three reasons FDA listed: dissimilar indication, design or technology.
The group says the final guidance should eliminate stress testing as part of the features analysis, or at least specify the maximum number of cases needed to meet FDA's expectations. As it stands, the guidance leaves too much to FDA's discretion, said James Thrall, chair of ACR's board of chancellors and chief radiologist at Massachusetts General Hospital.
"We would like to see as many overarching principles be put in place, assuming that they are reasonable, versus having this more open-ended situation," Thrall said in an interview.
FDA says the 510(k) data requirements will depend heavily on the types of detectors used in new systems.
"We expect that if most systems come along looking much like the ones we've already approved, then we wouldn't expect anywhere near the trials we've required to this point," FDA's Myers told "The Gray Sheet."
If a firm came out with a "very new" detector material, that would require more studies, she said. The main questions are: "Are there new technical concerns? Are there new safety concerns?"
Guidance Disadvantages Smaller Firms
At present the digital mammography market is dominated by a few large corporations.
Women's health firm Hologic, maker of the Selenia digital mammography system, controls 55%-60% of the U.S. market, followed by GE Healthcare (Senographe), Fujifilm (Fuji Computed Radiography for Mammography), and Siemens (Mammomat), according to JP Morgan analyst Tycho Peterson.
Downclassification could open up the field to newcomers, but not if the 510(k) process seems burdensome and expensive, said the American College of Radiology's Thrall.
That view is shared by Fischer Medical Technologies, a small firm that purchased Fischer Imaging's remaining x-ray business after the company sold off its mammography assets to Hologic.
In Aug. 28 comments, the company said it may "wish to enter the FFDM screening market in the future," but would be unable to finance clinical studies to definitively prove the medical efficacy of a new device.
"Now that there are four major players, small companies are not going to finance huge studies and compete in that market," Fischer Medical Technologies President Ronald Shores predicted.
Small firms are often the source of new innovations, he said, and there are still advances to be made. Next-generation digital mammography imaging systems in development include three-dimensional breast computed tomography (CT) scans and breast tomosynthesis.
FDA, too, has begun researching this "new wave" of breast imaging technology. Whether the next-gen systems will require 510(k)s or PMAs will depend on the complexity of the technology and what claims companies make, FDA's Myers said.
"The best thing to do is set up a pre-IDE meeting" with FDA, she advised.
- Jessica Bylander (j.bylander@elsevier.com)
"How can a person look themselves in the mirror when they lie to people on such a large scale, and about something so serious as llife or death."
Hahah, wow. Project much?
The "you're juvenile" adhom never gets old either. It's only second to "I bet you can't get laid" posit.
Oh Great Evil Orac,
I'm infested with a screaming horde of mindless woobots, spouting terraturds of blithering nonsense. Ignoring the USAian Generalissimo coronation doesn't help. They're still out there, dumping far too much CO2 into the air, whining that I'm not related to some apes, praying for smallpox to infect my children after it infects theirs, et al. And there's the DHMO menace, due to end the world in 2012. They seems immune to evidence and reason and criticism and even simple questions like "why?" I've recently taken to feeding them to the alligators, and am now knee deep in the big hungry things. (Would you like a cuddly pet?)
Perhaps I should try your approach and lie. "Yes, you're right, little green spiders from Mars will soon kidnap Jimmy Hoffa to further Teh Gay Plot and that's what has caused the current downturn economic worries and why you need to pray harder."
Many thanks for the suggestion.
Yours in Teh Big Truths,
As one who just recently came out of treatment of Hodkins, this saddens me enormously.
Hodkins, at least in my experience, isn't really that bad. I was stage 3 (tumors widespread in the lymph system, but not yet spread to the bone marrow), and still had 95% probability of getting completely healed. Seriously, if you have to get cancer, this is actually one of the better ones! Way easier than the mammary cancer my mother had to deal with at least.
To resort to woo when cure is near certain with convential methods, is just incomprehensible to me. It isn't like the standard chemo regiments are particularily hard even. I just fail to understand how parents willingly can take the other path into the dark woods of woo, when evidence based medicine can show such impressive results like in the case of Hodkins. The mind, it boggles.
There's actually some news about him that I just saw this morning. More on that later, probably on Monday.
Oh, come on, Orac: give us a link, at least. Please?
You're a bad man, a very bad man. I am going to wish you into the corn field.
Well, they did name the kid 'Starchild'... Abraham is his middle name, and the one he goes by. No doubt the parents make the argument 'weed is natural, man, and our medicine should be, too'.
I don't hold anyones choice in recreational chemistry against them (I'll admit I would rather have a nice beer, if it's all the same to you, preferably something dark) but, seriously - if you're gonna name a kid, get sober for a week first, eh?
I came across this article and thought you would find it interesting. It doesn't necessarily go with this post, or the previous one. Really.
http://www.huffingtonpost.com/billy-kimball/how-stupid-do-they-think_b_…
You're a Bad, Bad Man ? Who is this guy, Larry Craig ?
Will he be calling you a Naughy, Naughty Boy next?
As much as I'd like to see Abraham Cherrix have a good outcome for his cancer, Hoxey therapy would have killed him.
Had he gone through with that, we'd be writing about young Mr Cherrix in the past tense today. At least Dr. Smith's less-than-optimal treatment was better than the almost always lethal hoxey hoax.
With enemies like these...who needs friends?
If everyone in the world who thinks like this hates you with the fire or 100 burning suns, then you have done your job well.
If everyone in the world who thinks like this drops out of society and joins a hippy commune, well, that'd be too much to ask.
Dear Dr. HORRIBLE Orac:
Please e-mail me details of your big bribes from the medical industry. I am tired of shilling and selling my soul for nothing.
Yours,
The Dark One
I just found your blog - a veritable oasis in a desert of nonsense - and this is one of the first of your posts that caught my eye. Thanks for the information and the laughs.
I'm sure ad hominum attacks are to be expected, but they're sure to be more than balanced by the pro hominum opinion of you.