FDA
oracknows | August 30, 2017Yesterday I discussed a highly unethical clinical trial of a new herpes vaccine, based on what appears to be questionable science but backed by über-Libertarian Peter Thiel. The reason the trial is so unethical is because Rational Vaccines, the company that developed the herpes vaccine and is conducting the clinical trial, not only arranged to carry it out offshore but, unlike all American companies carrying out clinical trials offshore for purposes of gathering data to support an application for FDA approval, Rational Vaccines apparently carried the trial out without any oversight by an…
oracknows | August 29, 2017I've caught a fair amount of flak over my opposition to so-called "right-to-try" laws. Right-to-try laws have proliferated throughout the US like so much kudzu over the last three and a half years, to the point where 37 states now have some version of these profoundly anti-patient laws on the books. At the federal level, three weeks ago the Senate passed a federal version of right-to-try, with the House scheduled to take up the bill when Congress returns from recess next week. Granted, it's watered down and therefore less horrible than the original version, which Senator Ron Johnson (R-WI_…
oracknows | August 21, 2017Poor Robert F. Kennedy, Jr. He went from admired environmental activist to reviled antivaccine campaigner so quickly. It began when he outed himself in 2005 with his infamous conspiracy mongering screed about thimerosal in Salon.com and Rolling Stone. Basically, RFK Jr. is a member of what we used to call the mercury militia, a branch of the antivaccine movement that believes, more than anything else, that it is the mercury-containing preservative thimerosal that used to be in several childhood vaccines until 2002 drove an "epidemic" of autism. He's still a member, too, having recently…
oracknows | May 21, 2017Last week, I wrote about acupuncture, specifically how acupuncturists are unhappy that the UK National Institute for Health and Care Excellence (NICE), which provides guidelines for recommended treatments for diseases and conditions, does not recommend acupuncture for the treatment of knee osteoarthritis but does recommend arthroscopic washouts and debridement, for which the evidence is weak. My retort was simple: If this is true, the answer is not for NICE to start recommending quackery like acupuncture, but rather for it to stop recommending conventional medical and surgical treatments with…
oracknows | April 27, 2017I was going to write about this yesterday, but seeing a family of a child with terminal cancer seduced by the siren call of Stanislaw Burzynski and his antineoplaston quackery distracted me and I had to blog about it. It's actually an appropriate lead-in to this story, which was based on an announcement by the FDA that it was sending warning letters to 14 companies for selling products that they claimed were treatments for cancer:
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently…
The failure of the Texas Medical Board: Houston cancer quack Stanislaw Burzynski is back in business
oracknows | April 26, 2017When last I wrote about Houston cancer quack Dr. Stanislaw Burzynski nearly two months ago, he had, as I characterized it, just mostly slithered away from justice once again. The Texas Medical Board had not removed his license and had only fined him relatively lightly given his offenses. True, he had conditions placed on his continued practice (more on that later), but it hasn't slowed him down, as you will soon see. Another family is raising funds, this time from the UK, to travel to Houston for his nostrums. Basically, by failing to revoke Stanislaw Burzynski's medical license, the Texas…
oracknows | April 23, 2017Anyone who has been reading this blog for the last three years or so knows that I'm not a fan of "right-to-try" laws. Basically such laws, which have sprung up like kudzu since 2014 and now exist in 33 states, purport to allow terminally ill patients the "right to try" experimental therapeutics. Thus far, they have been sold to the public as giving terminally ill patients "one last shot" and touting how such laws could save lives. As a result, as I've grimly quipped on multiple occasions, to politicians opposing right-to-try laws is akin to opposing motherhood, apple pie, and the American…
oracknows | April 16, 2017From the moment that Donald Trump was unexpectedly elected President, I couldn't help but be concerned about what President Trump would mean for medical science and science in general. I was not alone in my concerns. Of course, now, five months later, we know that such concerns were quite valid. If funding is a primary indicator, then, if anything, my concerns expressed last November were understated. For example, in his first budget, Trump proposed cutting the National Institutes of Health (NIH) budget by 19%, and, then, not content with that, proposed cutting $1.2 billion from this fiscal…
What if, rather than being too stringent about drug approval, the FDA is not being stringent enough?
oracknows | February 12, 2017There is a belief that is very prevalent among policymakers right now, particularly Republican policymakers, that the key impediment to drug development is the Food and Drug Administration. According to this narrative, the FDA is an overly strict, overly bureaucratic, and rigid organization that is the main barrier keeping fantastic cures to all sorts of deadly and debilitating diseases from flowing to the people at a reasonable price. The basic idea, as I've discussed many times, is that, if only the FDA would get out of the way, universities and pharma would be free to open the floodgates…
oracknows | January 15, 2017One of the most important, if not the most important, officials in the federal government responsible for applying science-based medicine to the regulation of medicine is the FDA Commissioner. As you might imagine, particularly after his having met with antivaccinationists like Andrew Wakefield and Robert F. Kennedy, Jr., I am concerned, and I think I have good reason to be, about Donald Trump's plans for the FDA. After all, consider the people who have been under consideration for the post thus far (that we know of). First, there was Jim O'Neill, a flunky of Silicon Valley venture capitalist…
oracknows | December 13, 2016I’ve seen it noted that our new President-Elect seems to be selecting his cabinet officers and directors of federal bureaucracies based on how much they oppose the mission of the department they are supposed to head. For instance, to head the Department of Health and Human Services, he picked an orthopedic surgeon who belongs to an organization utterly opposed to any role of the federal government in health care and who himself looks poised to dismantle as much of the Affordable Care Act as he can. For the Department of Energy, he picked Rick Perry, a man so dumb that when he was asked during…
oracknows | December 8, 2016Yesterday, I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his brain mapping initiative. You can have additional funding to combat the opioid crisis. You can have all that, but only if you also accept a grab bag of longstanding pharmaceutical industry wishes, such as new pathways to approve drugs and devices with a lower standard of…
oracknows | November 20, 2016It’s been two weeks since Donald Trump unexpectedly won the Presidential election despite losing the popular vote. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here many times dating back to 2007, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled not just once, but twice. As you might imagine, I was not pleased.
Leaving…
oracknows | November 15, 2016Whenever I write about homeopathy, I almost always refer to it at least once as “The One Quackery To Rule Them All.” It’s a phrase I’ve used to describe homeopathy for several years now, and for good reason. Of all the quackery out there, with the possible exception of reiki, homeopathy is the one that is most obviously quackery. Its two main “Laws” are so clearly pseudoscience that you’d think it incredibly unlikely that anyone would fall for such nonsense, but fall for it they do.
I’ll briefly show you what I mean. That I can do so this briefly should show those unfamiliar with homeopathy…
oracknows | October 19, 2016It’s been a while since I wrote about Stanislaw Burzynski, the Polish ex-pat physician who is not an oncologist but treats cancer patients in his Houston clinic with a mixture of a compound he calls “antineoplastons” (ANPs) and “gene-targeted” therapy. The former are really a mixture of various chemicals he isolated from the blood and urine back in the 1970s, including chemicals like phenylacetic acid (PA) and phenylacetyl glutamine (PAG), that he thought to be endogenous cancer suppressors but has never been able to demonstrate that they are, despite having had four decades to do so.…
oracknows | September 5, 2016It's been nearly two weeks since a new "right to try" bill (AB 1668) passed the California legislature with overwhelming support and was sent to Governor Jerry Brown's desk to be signed. Thus far, he has not signed it, which is good, but neither have I seen a story that he has vetoed it either. In the meantime I learned some more about a federal version of the bill, which I will discuss after a brief recap of why right-to-try is such bad policy, which will lead into a discussion of the federal bill.
For those unfamiliar with right-to-try, such bills claim to allow terminally ill (or, in some…
kkrisberg | August 26, 2016The verdict on whether electronic cigarettes are safer than traditional cigarettes is still very much out. However, a recent study found e-cigarette emissions contain a variety of concerning chemicals, including some considered to be probable carcinogens.
In a study published in July in Environmental Science & Technology, researchers found significant levels of 31 harmful chemical compounds in e-cigarette vapors, including two that had yet to be detected: propylene oxide and glycidol, both of which health researchers have described as reasonably anticipated to be human carcinogens.…
oracknows | July 31, 2016During the political battle last year over the recently implemented California law SB 277, which eliminates nonmedical exemptions to school vaccine mandates and then later during the campaign for the Republican nomination for President, I used a term regarding antivaccine views. That term was “antivaccine dog whistle.” In politics, as you probably now, a “dog whistle” is a term for coded messages that sound like advocating principles with broad acceptance but to a certain subgroup are recognized as code for something else. The analogy is obvious. Just as humans can’t hear much of a dog…
oracknows | June 2, 2016One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, one thing that used to drive me absolutely bonkers was the tendency of the press to include in any story about vaccines an antivaccine activist to “tell the other side” or for “balance” to the story. So in a story on vaccines, on the one side you would have Paul Offit, a bona fide, legitimate vaccine expert, and on the other side you would have J.B. Handley, Jenny McCarthy, Andrew Wakefield,…
oracknows | February 23, 2016I didn't think I'd be writing about Stanislaw Burzynski again so soon, but to my surprise a very good article in Newsweek describing cancer quack Stanislaw Burzynski popped up in my Google Alerts yesterday. I hadn't expected much in the way of news coverage about Burzynski for several months, given that the second half of Burzynski's trial before the Texas Medical Board had been delayed by his having suffered a heart attack and isn't expected to begin again for several months. Entitled Cancer "visionary" Stanislaw Burzynski stands trial for unprecedented medical malfeasance and by Tamar…