Food and Drug Administration
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_…
lborkowski | July 24, 2017Members of the public health community are aware of many of the ways the Trump administration and the 115th Congress are hindering and reversing evidence-based actions for public health – from an executive order requiring agencies to scrap two regulations each time they create a new one to advancing legislation that would make it harder for EPA to obtain and use the most up-to-date science in its work. With so many threats to public health arising each month, it can be hard to catch all of them, though. The Union of Concerned Scientists has performed a tremendous service by producing the…
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…
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.…
kkrisberg | February 12, 2016Manufacturers who market their products as “BPA-free” aren’t just sending consumers a message about chemical composition. The underlying message is about safety — as in, this product is safe or least more safe than products that do contain BPA. However earlier this month, another study found that a common BPA alternative — BPS — may not be safer at all.
“BPS works very similarly to BPA,” said Nancy Wayne, a reproductive endocrinologist and professor of physiology at the University of California-Los Angeles David Geffen School of Medicine. “We’re not the first to show this, but what’s captured…
kkrisberg | December 16, 2015In a recent study, Harvard public health researchers decided to test a few dozen types of electronic cigarettes for diacetyl, a flavoring chemical associated with a severe respiratory disease known as “popcorn lung.” The researchers found diacetyl in a majority of the e-cigarettes they tested. News outlets jumped on the findings, with some announcing that e-cigarettes could cause the often-debilitating respiratory disease.
But scientist Joseph Allen wants to be clear: His study doesn’t make a definitive statement about the effect of diacetyl in e-cigarettes. Instead, Allen said his goal was…
kkrisberg | October 28, 2015The Centers for Disease Control and Prevention recently released the first nationally representative estimates of electronic cigarette use among U.S. adults, finding that more than 12 percent had ever tried the aerosol nicotine products in 2014. So, as is the unfortunate case with many emerging and potential public health threats, it seems like e-cigarette use is outpacing the ability of regulatory bodies to protect the public’s health and educate consumers about possible risks.
The new data is from CDC’s National Health Interview Survey, which first began collecting data on e-cigarette use…
oracknows | September 18, 2015Homeopathy is a frequent topic on this blog, for reasons that regular readers no doubt understand all too well by now. Homeopathy is, as I like to call it, again borrowing from Tolkien, The One Quackery To Rule Them All. When it comes to quackery, few can even come close to homeopathy for the sheer ridiculousness of its precepts. Whether it is the Law of Similars, which claims that to cure a disease you need to use a substance that cause's that diseases symptoms in healthy people, a "law" that has no basis in science, or the Law of Infinitesimals, which postulates that serially diluting a…
cmonforton | September 3, 2015For part of this summer, I escaped the sweltering heat of central Texas and took refuge in Leamington, Ontario, Canada. It's a lovely place in southern Ontario on the banks of Lake Erie. From my sister's cottage, I could see Pelee Island on the horizon.
On a morning walk, the nose of my golden retriever Laredo drew me to a small, smashed cardboard package. It was an empty pack of DK's Full Flavor Premium Canadian Blend cigarettes. But the product and brand on the label were dwarfed by the graphic warnings on four of the six sides of the box.
A cigarette pack I found on the side of the road…
kkrisberg | April 17, 2015In just a year, electronic cigarette use has tripled among American teens. And considering that no one really knows what the related health impacts are and any regulatory framework is lagging far behind the growing popularity of e-cigarettes, public health advocates say it’s time for action.
Earlier this week, the Centers for Disease Control and Prevention released new data from the 2014 National Youth Tobacco Survey finding that current e-cigarette use among high school students, which is defined as using at least once in the prior 30 days, nearly tripled — from 4.5 percent in 2013 to 13.4…
oracknows | March 27, 2015Homeopathy is quackery. It can't be repeated often enough.
Homeopathy is The One Quackery To Rule Them All. It is based on prescientific vitalism and principles so addled that one must wonder whether Samuel Hahnemann, the guy who dreamt up this medical system, was a fan of excess alcohol use, opium, marijuana, or some unholy combination of the these. Think about it. The first principle of homeopathy is the law of similars, which states that like cures like. In other words, to relieve a symptom, homeopathy tells us, you must use something that causes that symptom in healthy people. There is no…
kkrisberg | February 13, 2015When the U.S. Food and Drug Administration approved the first vaccine to protect against cancers caused by certain strains of the human papillomavirus, or HPV, public health advocates cheered its arrival and life-saving potential. Unfortunately, the new vaccine quickly became embroiled in a debate over whether immunizing young girls against HPV, a sexually transmitted disease, would lead to risky sexual behavior. A new study, however, finds that the vaccine is not associated with an uptick in STDs — an indicator that HPV immunization does not promote unsafe sex.
To conduct the study, which…
kkrisberg | November 12, 2014Decreased lung function, breast cancer, miscarriage, depression and neurological disease. These are just a few of the health and disease risks that salon workers disproportionately face while on the job, according to a new report on the impact of toxic chemicals within the beauty and personal care industry.
Yesterday, Women’s Voices for the Earth, a nonprofit working to eliminate toxic chemicals from workplaces, homes and communities, released “Beauty and Its Beast: Unmasking the Impact of Toxic Chemicals on Salon Workers,” which highlights decades of research on beauty care workers and…
oracknows | October 28, 2014
One of the biggest medical conspiracy theories for a long time has been that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or…
egrossman | September 22, 2014“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…
oracknows | August 13, 2014
There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy over at SBM and I have both written about them before. With the passage of the first such bill into law in Colorado in May, followed by Missouri and Louisiana, and its heading to the voters of Arizona as…
oracknows | July 14, 2014
There’s a point I feel that I have have to make briefly as I begin this post. Basically, this might look familiar, but given that I was at TAM Wednesday through Sunday, I didn’t have time to produce two separate posts, and this is important enough to be distributed as widely as possible. In any event, as I started writing this, I was on a miserably crowded, hot, stinky flight winging my way home from TAM (nothing like being stuck in coach on the tarmac in the middle of the desert before taking off—the sweat never quite goes away even after the plane cools down). This puts me in the perfect…
oracknows | June 25, 2014It'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…
oracknows | March 10, 2014I forgot if I ever mentioned that I have an article out in the current episode of Skeptical Inquirer about Stanislaw Burzynski. I call it a "primer for skeptics," because that's what it is. So, if you subscribe to SI (Skeptical Inquirer, not Sports Illustrated), read. If not, get thee to a newsstand before it's gone. Thus endeth the plug and beginneth the Insolence.
When last I discussed Stanislaw Burzynski, I noted that, among other things, the state of Texas appears far more interested in putting abortion providers out of business than it does in protecting its citizens suffering from…