One of the cherished strategies of the anti-vaccine religion is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other areas) to “prove” that vaccines are dangerous. These vaccine deniers consider the package insert to be the golden tablets of the Truth™.
Yes, it is cynical that these anti-vaccine groupies rail against Big Pharma as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. And there is another broken irony meter.
Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to a section in any of the many vaccine package inserts (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. Or that it doesn’t work.
The snarky Orac has proclaimed it “Argument by Package Insert” – it’s almost at the level of logical fallacy. David Gorski has just given it the Latin name, argumentum ad package insert, so it’s now officially a logical fallacy, at least for vaccine discussions.
Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. However, vaccine package inserts are not documents that serve as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. Continue reading “Argument by Vaccine Package Inserts – they’re not infallible”
One of the most ridiculous myths of the anti-vaccine world is that vaccines made in China dominate the US market. I took a look at every vaccine licensed for use in America to determine where they are manufactured. Spoiler alert – none are made in China.
I didn’t even know this was an anti-vaccine myth until recently. But once I looked into the topic, it was clearly prevalent in the anti-vaccine world. Many vaccines are manufactured in the USA, but the remainder are made in Canada, Japan and Europe.
Here’s a list of the most important vaccines licensed in the United States with their location of manufacture. Continue reading “Vaccines made in China – another ridiculous anti-vax myth”
As a vaccine supporter, I get accused of being a shill for Big Pharma all the time. My basement is filled with gold bars shipped to me in remuneration for my services to the corporate hooligans – wait. No basement, no gold bars. On the other hand, Big Supplement, those companies who make money off of people who think that if they take this one vitamin to prevent all cancer, makes a a ton of money selling this junk medicine to unwary and unsophisticated consumers.
Let’s take a moment and look at the differences between Big Pharma and Big Supplement. The former has to work hard and provide evidence of what its drugs do, while the latter basically can sit around and throw darts at various claims, then randomly assign those claims to some new or old supplement.
For faithful readers of this blog, you know I try to keep focus on a small field of science – vaccines, GMOs, alternative medicine, and whatever strikes my fancy. I get all excited when a couple of my interests intersect, like GMO vaccines. Then I read a blog post from some writer, Jon Rappoport, who started out with criticism of Donald Trump and what he might do with the FDA. That got me excited.
Now a lot of us are worried about what Donald Trump might do with the FDA. The cantankerous Orac summed up many of our thoughts about Trump and the FDA thusly:
Obviously, though, I don’t like either of the two candidates under consideration by the Trump transition team to become FDA Commissioner. Basically, you have to pick your poison: Do you want the libertarian who doesn’t think that the FDA should have to require the demonstration of efficacy before approving drugs or the bona-fide, honest-to-goodness pharma shill, someone who’s pharma shill to a level that most pharma shills only dream of? It’s basically Sophie’s choice.
But Jon Rappoport quickly went off the rails by attacking the FDA and claiming GMOs are dangerous (and the FDA should regulate them). Here we go.
Continue reading “Jon Rappoport attacks GMOs and medicine – should we care?”
Recently, president-elect Donald Trump nominated Georgia congressman Tom Price to be Secretary for Health and Human Services (HHS). Price is a medical doctor whose impact on politics has been almost exclusively based on his unwavering opposition to the Affordable Care Act, known as Obamacare.
Once Trump was elected, along with a Republican Senate and House, most of us in healthcare knew that Obamacare was probably doomed. I don’t think it will be easy for the Republicans, now that they’re in power, to actually dismantle Obamacare, especially some of the more popular provisions such as elimination of the pre-existing conditions as a disqualification for receiving health insurance.
Also, there are over 20 million Americans who have taken advantage of health insurance from Obamacare, and I think it would be almost impossible for the Republicans to cut them off. But I may be delusional about the limits of Republican dislike of poorer Americans.
Setting aside healthcare insurance, what else may be impacted by Tom Price? Well, the Department of Health and Human Services is responsible for many of the important health care institutions that matter to me and my readers. Some of the major institutions under the HHS umbrella are:
- The National Institutes of Health (NIH) – the nucleus of biomedical and health-related research in the USA. Much of the research at NIH, which has an impressive world-wide reputation, serves as the foundation of much of what we know about human health and disease.
- The Centers for Disease Control and Prevention (CDC) – if you are a reader of this website and blog for the past 5 years, you know I, and many others, have tremendous respect for the CDC. It functions as the frontline, first responders if you will, for any disease that appears in the world. It is made up of some of the leading scientists, public health specialists, and thought leaders in healthcare, who give their careers to help humanity. And, of course, they set vaccine policy for this country. The CDC has tremendous influence on public health across the globe.
- The Food and Drug Administration (FDA) – the primary regulator of pharmaceuticals, medical devices, food, diagnostics, supplements, and many other areas, it is one of the most powerful agencies in the world for protecting the health of consumers.
- The Centers for Medicare and Medicaid Services (CMS) – the federal agency that administers the Medicare program along with advising the states on Medicaid and other public health care programs.
Tom Price will have significant influence on much of the science of medicine, let alone the financing of health care in the USA. There is one thing in Price’s background that give us some significant insight as to how he’ll run his department – let’s just say, it’s not good. Yeah, none of us of would have predicted this.
Continue reading “HHS nominee Tom Price and a radical right-wing physician organization”
As I’ve written more times than I can imagine, in the hierarchy of scientific evidence, the best primary evidence for the usefulness of any therapeutic method (including medications) are clinical trials, with double-blind, randomized ones considered the gold standard.
Despite the fact that clinical trials form the foundation of all medical evidence, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device flies through this process, with Big Pharma’s desires taking precedence over science.
Big Pharma and development of drugs are a bone of contention, even to those who don’t jump on board the various conspiracies about the pharmaceutical industry. There is a myth that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies), and does whatever it wants.
But let’s look at it carefully, including how most drugs are developed and brought to the market. Let’s try to separate the myths of Big Pharma and development of drugs from the facts.
Continue reading “Big Pharma and development of drugs – debunking myths”
Over the past few months, the Zika virus, a mosquito borne disease that is passed from the mother to the developing fetus, has become the focus of a lot of attention because of the danger it poses to the fetus. There are no vaccines or treatments for the virus, so the best we can do is stop the carrier, two species of the Aedes mosquito. Probably the best way to prevent Zika virus spread is with genetically modified mosquitoes, the Frankensquito.
Even though mosquitoes are the main way to be stricken with the Zika virus, it is even crazier than that. Men and women who contract the disease can then transmit it sexually to their partners. So even those who are nowhere near the Zika carrying mosquitoes may be at risk of getting the virus.
Recently, there have been numerous cases of Zika virus infection in south Florida, and, because of the lack of effective preventative vaccines and treatments, public health officials have looked at other methods to prevent Zika virus. The most effective way is to eliminate the carriers of this virus, mosquitoes.
I have written several articles about these GMO mosquitoes, but that had been with regards to preventing Dengue fever, also a dangerous mosquito carried disease. But just like the “outcry” with the Frankensquito and Dengue fever, we’re hearing almost the same nonsense with respect to Zika virus. Let’s look at the scientific facts, with the hope that some will see the importance of prevention.
Continue reading “Prevent Zika virus with GMO mosquitoes – Frankensquito returns”
On 19 November 2015, the US Food and Drug Administration (FDA) announced that a new GMO salmon, called AquAdvantage, is just as safe as any other salmon for consumption. The FDA based their decision on boatloads of data submitted by the company that developed the GMO salmon, Aqua Bounty Technologies, along with independent peer-reviewed data.
The approval process, taking nearly 20 years, for this transgenic salmon far exceeded the process required for pharmaceutical drug approval. The original application was filed in 1996, and data from 10 generations of the salmon had to be submitted to the FDA. It would be a ridiculous myth to claim that the FDA just bowed to the GMO salmon industry.
Of course, just like every other genetically-modified food ever developed, fear and loathing takes precedence over logic and scientific evidence. A major grocery store chain in the USA, Costco, has refused to market the fish, followed by other expensive grocery chains like Whole Foods, a promoter of pseudoscience in foods. A few countries have even written new regulations to block its import.
As can be expected, any group that doesn’t agree with the scientific evidence, turns to courts to help them out. Anti-vaccine and anti-climate change radicals love to do this, though they usually fail. In the case of the GMO salmon, the radical anti-GMO group, Center for Food Safety, has announced that they will proceed with a lawsuit to block introduction of this fish. Once again, scientific evidence is ignored or cherry-picked in lieu of the pre-existing conclusion that GMO salmon is unsafe.
Time to look at this story with a bit more of a critical, skeptical analysis.
Continue reading “Something’s fishy – GMO salmon is on its way”
Yes, you read that right. This so-called shill for the pharmaceutical industry is calling them as I see them – most published medical research is a failure – but stay tuned for the full story.
Now by failure I mean that more often than not, claims that are supported by one or two published articles, rarely lead to a clinically significant product (such as a pharmaceutical). Of course, I don’t mean that the research is fraudulent, although some are, especially in low level journals frequented by pseudoscience pushers.
And I don’t mean it’s bad science, although there’s evidence of that, which I’ll discuss below.
And I don’t mean that there’s some grand conspiracy between Big Pharma and everyone else (again, no evidence to support that nonsense), although there is some evidence that research sponsored by Big Pharma is poorly done.
So what do I mean? Results from lot of medical research that get splashed in the news rarely, and I mean rarely, end up having any clinical utility. Rarely, but not never.
This does not mean that medical procedures, pharmaceuticals and devices that have been vetted through lots of research that repeat and confirm the original data and that form the basis of a scientific consensus are bad research. Almost everything that passes by the FDA and other regulatory agencies in other countries meets high standards for risk and benefit analysis.
Finally, arriving at a scientific consensus is a brutal, time-consuming process. It means that the theory or idea has been repeated many times, and the analysis and data are solid. So even though “most” research ends up in a failure, that’s because science is harsh to research that can’t be repeated, or was badly designed.
The best research isn’t a failure, even if it finds negative results. And the best ideas in medicine, let’s say vaccines, have been so thoroughly vetted that the consensus is nearly unassailable. Though people try with their poorly designed, unrepeatable research.
Continue reading “Published medical research is a failure – not what you think”
This is Part 6 of a series of six articles discussing various medical uses for cannabis or marijuana. In this part, I summarize all of the five previous articles into some bullet points so that you have quick and fast access to some scientific information about medical uses for cannabis or marijuana.
In case you missed them, here are the first five articles in this series:
Part 1. Marijuana and medicine assessing the science.
Part 2. Marijuana and cancer – assessing the science
Part 3. Marijuana and neurological disorders – assessing the science
Part 4. Marijuana and health risks – assessing the science
Part 5. Marijuana and pregnancy – assessing the science
Maybe you don’t agree with the science about marijuana’s role in medicine. But that’s not how science works. The evidence should lead you to a conclusion (actually, the acceptance or rejection of a hypothesis). One shouldn’t form an a prior conclusion, then go hunt for data. That’s not how it works.
As new systematic or meta reviews bring more clinical evidence of the benefits of the medical uses for cannabis – this takes time – maybe evidence based medicine can incorporate marijuana into the armamentarium of medical practice. But only real clinical evidence matters.
So let’s review where the evidence leads us. Continue reading “Part 6. Medical uses for cannabis – the TL;DR version”