Texas Medical Board Rules: Fill & Download for Free

Any sane human being who is not a total effing douchelord would do exactly what this doctor did.If I were that doctor, I would have done exactly what he did.I would even do exactly what he did even If I knew I would be fired for it.There are some principles that I believe in so much that it really doesn’t matter what happens, I would still do what was ultimately the right thing to do.I can’t imagine any normal, rational person would disagree with what this doctor did.So now you understand the sort of people who rule over us and tell us what to do. Small minded, rigid, vindictive, greedy. Imagine if you had to do what these people tell you to do, even though every fiber of your being tells you that they are wrong. Fun times!

What publications? Oh! You mean the ones that got published in rubbish journals?There is very little that Stanislaw has done to fulfill the requests of the biomedical community to effectively demonstrate the efficacy of antineoplastons. A couple of years ago I peer-reviewed much of the "peer-reviewed material" and their work misses several extremely key controls and their "proof" uses incredibly questionable baselines. Also, he falsely advertises several elements of his "novel treatments".The medical community is in denial because he has repeatedly breached several rules of medical ethics for the purpose of profit and because of legal battles, he is protected from further action from the FDA and the Texas Medical Board.The scientific community is in denial because he has repeatedly breached several rules of scientific ethics for the purpose of profit. He makes unfounded claims and willingly lies to patients.Even if you exclude the ethical breaches, the science behind antineoplastons and the results and design of his "clinical trials" don't suggest that his treatments are causing any improvement in health.Stanislaw, I have waited for your return. I summon my answers from years past!!!Christopher VanLang's answer to Is the Burzynski clinic a scam?I've been thinking about this extensively and reading most of the papers that I can get my hands on. I've also been taunted by Patrick. Unfortunately, many of Burzynski's papers, while well written, are extremely cryptic and are not published in meaningful journals. However, from extensive literature reviews and help from various bloggers, mainly Orac (http://scienceblogs.com/insolence/) and Andy Lewis (http://quackometer.net/), lets give this a shot.Here is my interpretation. Stanislaw Burzynski has managed to game the healthcare system and is able to do medicine without the constraints of insurance companies under the guise of a clinical trial and "personalized gene-targeted therapy". The man is a genius because he is basically able to do what most doctors want to do without any of the legal or financial repercussions and with the ability to prescribe any off-label drug he desires. Furthermore, by telling his patients that they aren't receiving convential chemotherapy, he has successfully established himself as a "maverick" researcher.Now for the facts. Antineoplastons... probably don't work in the mechanisms that he claims. However, sodium phenylbutyrate, as mentioned by Ender, does have efficacy against glioma. Mechanism of action is essentially metabolism into phenylacetate which then becomes phenylacetylglutamine which ultimately goes into the urine. For those paying attention, its basically A10 and AS-2.1. So the compounds of antineoplastons do kind of work. As a result, Phenylbutyrate (PB) is a commercially available drug. So whats the difference between what Dvorit Samid's work with the NCI and Stanislaw Burzynski's work? This is where things begin to break down into chaos.Burzynski insists that the A10 (PAG) and AS-2.1 (PA) ratios have to be appropriately tuned. His studies also suggest that PAG and PA bind and influence essentially everything. Everything consists of 100-200 genes which includes but is not limited top53p21miRNA 125HDACPCNARASMYCCAny cancer biologists can tell you that when you're hitting any of these things, the body can go a bit crazy. From Orac:Yes, it does target genes, but not in the way commonly meant when we refer to "targeted therapy," which normally means targeting one or a handful of related genes. Rather, it targets lots of genes, making it, in essence, no more "specific" than chemotherapy.That rules out the "gene-targeted" lingo which will answer the pharmacodynamics question Is antineoplaston therapy gene therapy?. Lets look at the pharmacokinetics. Previous NCI trials over the course of the last 50 years have noted that PAG and PA are well tolerated but numerous side effects do occur and there is a MTD of 300 mg/kg/day. The recent NCI phase I trial looking at PA in 2006 stops are 125 mg/kg and a serum concentration of 490 ug/ml. These numbers are also inline with the 1994 NCI trial. The FDA approved Sodium phenylbutyrate, a prodrug I remind you, shows neurotoxicity at 190 mg/kg.Meaningless numbers for those who don't care about pharmacology. Most of them aren't extraordinary either as those numbers are quite high. What's the recommended A10, AS-2.1 doses? Try 10.3 g/kg/d for A10 and 0.38 g/kg/d. First off, that's 1% of the patient's body weight. Secondly, the 100x increase in dose was a huge point of disagreement between NCI and Dr. Burzynski back in 1994. Interestingly, recent clinical trials by the Burzynski clinic suggest that Burzynski is shifting back from PA and PAG to PB.As for the whole redifferentiation, epigenetic remodelling , bringing the body back to homeostasis model, as much as I would like to believe that its true, there simply isn't much evidence that any of that is occurring. Most of the cytotoxicity studies just show that cancer cells apoptoses if anything. This is very different from the proposed model of reprogramming the cancer cells back to a healthy state.Now for the Burzynski Clinic. They claim that they are providing "personalized gene-targeted cancer therapy". A large part of this includes a series of genetic tests probably using microarrays. Neat stuff. From that genetic information, the clinic prescribes a mixture of antineoplastons and FDA approved medicines. This is also a nice way of saying, he is doing want pretty much any doctor would do + antineoplastons. Here is an interesting except from the Texas Medical Board trialRespondent prescribed a combination of five immunotherapy agents - phenylbutyrate, erlotinib, dasatinib, vorinostat, and sorafenib-which are not approved by the Food and Drug Administration ("FDA") for the treatment of breast cancer, and which do not meet the FDA's regulations for the use of off-label drugs in breast cancer therapy.Well, one of those drugs includes PB but there others are a variety of anti-cancer drugs, ie. CHEMO. In fact, he is throwing a bunch of anti-cancer drugs that may or may not have an influence on breast cancer, using them in unapproved combination with unknown drug-drug interactions, and then telling his patients that he is prescribing that its all natural. Worse, by having his patients pay out of pocket, they remove themselves from the checks and balances provided by insurance companies and maybe even lawyers. However, from the videos, it does sound like the staff is super friendly and just having quality patient-doctor relationships can have a huge impact in the prognosis.The most unfortunate result from all of this is that the rest of the scientific community has not way of telling if what he is doing actually works. The "clinical trials" are poorly designed if designed at all. By using non-randomized single-armed trials, where each patient receives a different drug cocktail, its very difficult to see what effect the antineoplaston therapy does. Furthermore, the presented data uses heavily skewed data explained with unconventional, impractical metrics. Is the FDA being mean to Burzynski? Perhaps. Yet, Dr. Burzynski hasn't done much to demonstrate proof of concept barely even in cytotoxic and preclinical studies and the ensuing clinical trials are extremely difficult to interpret and untrustworthy.So in summary. Dr. Stanislaw Burzynski provides a warm clinic to the patient and due to various agreements with the FDA is allowed to run a variety of rather interesting "experiments" on his patients. In other words, patients pay for the guise of brilliance and escape from "conventional" treatment when they are probably getting a similar but potentially more harmful drug regime as a normal hospital.With that in mind, the ethics and scientific vigor of the clinic are certainly in question and the Texas Medical Board will have a very interesting case when they go to court in April.Now I'm upset because I was able to get the terrible thoughts of unethical actions out of my head two years ago and you reminded me about these violations.Your move.

Update: Since writing this answer, I’ve given more thought into health entrepreneurship, and written a book about it (Free on iBooks. More details at beforedisrupting.com). A better version of this answer appears in the book.Bright.After years of obscurity followed by a decade of hype, Telehealth is finally emerging as a viable mainstream trend. Here are three trends that prove that this paradigm shift is here to stay:Government thinks it’s legit. In January 2015, the CMS issued a new provider reimbursement code (CPT 99490) for non–face-to-face health care services for patients who have chronic medical conditions. It allows an approximately $40 payment for 20 minutes of non-face-to-face chronic care management (CCM) services per patient every month. That non-face-to-face part is what legitimizes Telehealth as something the government thinks is worth paying for. The amount may sound trivial, but do the math like this: average PCP has around 1500-2000 patients under care annually. Even if only 500 of those are eligible for CCM, there is an annual payment of $20,000 per physician on the table for remotely monitoring and interacting with patients. There are footnotes to the deal, of course. Like patients have to explicitly agree to be in the CCM program and shell out a monthly $8 co-pay. But this is the start of a torrent of federal money that will germinate the long-sown seeds of Telehealth, just like what HITECH Act did for EHR industry.Big vendors and deals are emerging. The top four players (Teladaoc, MDLive, Amwell, DoctorOnDemand) have continued double-digit growth and multi-million dollar fundings. Teladoc blazed the path and even went public in early 2015. The official bonds these companies have formed with health insurers is what really underscores future viability. Multiple deals have been struck with big names like United Healthcare, WellPoint, Aetna, and Cigna, and CVS Health to offer Telehealth as either optional-and-charged or as included-and-free service. When traditional insurers start offering Telehealth, it’s time to pay attention.Regulatory forces are moving fast. In April 2014, the Federation of State Medical Boards (FSMB) adopted a model policy[1] to guide the state licensure boards in evaluating the appropriateness of using Telehealth technologies in care delivery. 2015 saw more than 200 telehealth-related bills were introduced in 42 states[2]. Medicaid program in almost all states (49 actually) and the District of Columbia already have some coverage for Telehealth. In June 2015, Texas Medical Board stated their disapproval of virtual visits with physicians who have not previously seen patients in-person and ruled that provider-patient relationship can’t be established remotely. Dallas-based Teladoc, in turn, sued the Texas Medical Board for being anti-competitive. The analysis of all this legal wrangling shouldn’t be to predict winners or losers. A more important takeaway is that there is continuous movement. The legal landscape is shifting, and evolving faster than ever before.[1] https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_Policy.pdf[2] http://www.ncsl.org/documents/health/telehealth2015.pdf