FDA

The ‘Nifty Fifty (times 4)’, a program of Science Spark, presented by InfoComm International, are a group of 200 noted science and engineering professionals who will fan out across the Washington, D.C. area in the 2014-2015 school year to speak about their work and careers at various middle and high schools. Meet Nifty Fifty Speaker Dr. Alberto Gutierrez Welcome to the age of Personalized Medicine -- an emerging era of medical science which involves the development of drugs and other treatments that are tailored specifically to an individual patient, or a group, with certain genetic…
Ever since the latest outbreak of Ebola viral disease in West Africa, there has been panic that’s metastasized to the US, even though the risk of a major outbreak here is very low. Unfortunately, whenever there’s panic over a disease, whatever the disease is, there soon follows quackery in response to that panic, from quacks who are either looking to make a buck or who are true believers (or both). For instance, I’ve seen high dose vitamin C touted as an Ebola remedy. I’ve also written about deluded homeopaths claiming that homeopathy can be used to treat Ebola. One particularly deluded…
“Shift work refers to work that takes place outside of traditional 9-to-5 daytime hours. If you work nights or rotating shifts, you are a shift worker. Many people who work shifts are at risk for developing shift work disorder (SWD) and may experience excessive sleepiness (ES) on the job.” So says the website designed to market the drug known as Nuvigil, sold by Cephalon, a subsidiary of Teva Pharmaceutical Industries, Ltd. Approved by the US Food and Drug Administration (FDA) in 2007 to treat narcolepsy and obstructive sleep apnea and the excessive sleepiness that may come with working a…
Our regularly scheduled post will go live later this morning. In the meantime, this is a public service announcement...with GUITAR! (Oh, wait.) As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski's bogus clinical trials of antineoplastons, which he's used since the 1990s as a pretext to charge huge sums of money for "case management fees" to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators: “We are frankly stunned to hear that the…
It's hard for me to believe that it's been almost three years since I first started taking an interest in the Houston cancer doctor and Polish expat Stanislaw Burzynski. Three long years, but that's less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet, just a much smaller…
The Washington Post's After the Wars series offers an in-depth look at the challenges facing veterans returning from Iraq and Afghanistan. This past week, it's featured Rajiv Chandrasekaran's "The Other Wounds," about veterans' injuries and illnesses that aren't the direct results of enemy attacks, and Stephanie McCrummen's "The Choice," about one of the  difficult decisions facing survivors of military sexual assault. An unprecedented release of Medicare data has allowed for a lot of reporting on how much Medicare pays physicians; Puneet Kollipara rounds up several articles in Wonbook. Two…
"Just when I thought I was out, they pull me back in." I know I've used that quote before several times over the 9+ years that I've been blogging. These days, I probably use it most frequently when it comes to the topic of Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was yesterday when i was made aware of a new development so disappointing that I'm still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that…
Amidst all the sturm und drang after a recent post, I was reminded elsewhere on the blog why I do what I do. So I'm going to do more of it today. You might recall Liza Cozad, wife of David Lauser, who is the drummer in Sammy Hagar's band. She has an inoperable brain tumor and wants to try Stanislaw Burzynski's antineoplastons. However, because of the partial clinical hold on his clinical trials, she can't get them. Unfortunately, now she and her husband have been using their names to lobby Congress to pressure the FDA to allow an exemption. I wrote a post about this around a month ago. The…
When President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011, it was described as the most sweeping reform of the nation’s food safety laws in nearly a century. Public health advocates hailed the law for shifting regulatory authority from reaction to prevention. What received less attention was a first-of-its-kind provision that protects workers who expose food safety lawbreakers. The law’s whistleblower provision, also known as Section 402, amends the federal Food, Drug and Cosmetic Act to provide “protection to employees against retaliation by an entity engaged in…
“The United States is facing an industrial chemical safety crisis,” Chemical Safety Board Chairperson Rafael Moure-Eraso told the Senate Environment and Public Works Committee on March 6th. He spoke at hearing held to discuss President Obama’s August 2013 Executive Order on chemical facility safety, which Obama issued following the catastrophic incidents at the West, Texas fertilizer plant and Louisiana petrochemical facilities. In the wake of the Freedom Industries chemical release in West Virginia, improving the nation’s chemical safety has taken on a new urgency. Yet while the Senate…
I don't know if it's a sign that I've arrived as being a bit more influential than just a blogger or just dumb luck when reporters start sending me things, but I'll take it. It's like blog fodder being served to me on the proverbial silver platter. Unfortunately, as a result of receiving a press release, FDA Denies Treatment to Two Terminally Ill Young Women, from two different sources, after yesterday's hilarious (if I do say so myself) bit of fun with a certain woman who fancies herself a "Thinker" when everything she writes shows that she is anything but, I find myself tackling a much more…
In a first-of-its-kind study, a researcher has estimated that the health-related economic savings of removing bisphenol A from our food supply is a whopping $1.74 billion annually. And that’s a conservative estimate. “This study is a case in point of the economic burden borne by society due to the failure to regulate environmental chemicals in a proactive way,” study author Leonardo Trasande told me. With evidence mounting that bisphenol A (BPA) exposure is a serious health risk, Trasande, an associate professor in pediatrics, environmental medicine and health policy at New York University,…
I realize that I just wrote about infamous cancer doctor Stanislaw Burzynski yesterday. (Note how I refuse to call him an "oncologist," mainly because he isn't one, having never completed an oncology fellowship—or even an internal medicine residency, the usual prerequisite to do an oncology fellowship.) However, there's a bit more that I wanted to touch on before moving on to other topics. What brought this on was a Google Alert that appeared in my in box yesterday relevant to yesterday's post. You might recall that yesterday I mentioned a campaign by the Alliance for Natural Health USA (ANH-…
The year 2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed "antineoplastons" (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski's "clinical trials" (and I use the term…
By Lisa Matthews Bladensburg High School and the biomedical sciences program welcomed Dr. Margaret Hamburg, Commissioner of the FDA, on Wednesday January 15th as a Nifty Fifty Speaker, sponsored by InfoComm International.  She was honored with a color guard, musical presentation and was presented by the Mayor of Bladensburg with a proclamation honoring her accomplishments.  She reciprocated with a compelling and interesting discussion of her career path and opportunities with the FDA, and a message to the student of Bladensburg to continue on the path they have taken that focuses on math and…
The central mystery of Stanislaw Burzynski is how he keeps managing, no matter what is thrown at him by state and federal medical authorities, to keep on treating patients with deadly cancers. He's like the Energizer Bunny; he just keeps going and going and going and going. Or maybe he's like the game Whac-A-Mole™, where, as soon as one strategy seems on the verge of shutting him down he pops up elsewhere with another angle. Burzynski, as regular readers know, is the Houston doctor (I refuse to call him a cancer doctor, because he has no formal training in oncology or even board certification…
"I played by the rules. I worked to support my family. The unregulated industry virtually destroyed my life. These chemicals that are used on food in large-scale production must be tested, and proper instructions and labels supplied with their sale." Those were the words of Eric Peoples at a congressional hearing in 2007. He testified about his experience working at a food-manufacturing plant where he was exposed to flavoring chemicals including diacetyl. Those exposures led to severe lung damage. At the time of his testimony, Peoples was awaiting a lung transplant. Eric Peoples became one of…
I don't normally ask you, my readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it and, if so inclined, to cover my back by swatting down the trolls, quacks, and antivaccinationists who occasionally show up to infest the comments, so that I don't have to. However, given the story of Stanislaw Burzysnki, which I've been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that "co-conspirator" bit was sarcasm) to take…
I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his…
It's been a while since I've written about Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he never published a completed phase II trial. The only evidence he's published consists mainly…