Chinese vaccine scandal – not a concern for USA and many other countries

Chinese vaccine scandal

Recently, a Chinese vaccine scandal has been reported in many news sources. According to these reports, a Chinese vaccine manufacturer produced and marketed “low-quality” vaccines for infants. Moreover, they falsified production and inspection data on a rabies vaccine – as I’ve written before, rabies is a deadly disease, with almost 100% mortality after symptoms appear,  and the vaccine is the only choice to save lives.

This is an appalling story on so many levels. Authorities in the country had lax enforcement and regulation of their vaccine industry – the government was attacked on social media about the situation, a rarity in a communist country where free speech is strictly limited. As a result, the Chinese government will begin regulating their vaccine manufacturers more closely, although it may be too little and too late.

On the other hand, Hong Kong utilizes mostly “Western” manufactured vaccines, which has led to many Chinese citizens going to that autonomous region to get their children vaccinated. There are websites devoted to showing how parents can avoid Chinese vaccines and get the “good stuff.”

These kinds of outrageous ethical lapses generally do not happen in the USA, Europe, Japan, Canada, Australia, and many other countries. Falsifying data can lead to severe criminal prosecution and civil penalties, something that is far beyond the response from Chinese authorities to this scandal.

Of course, this has led to one of the most ridiculous myths of the anti-vaccine world – our vaccines are dangerous because they were manufactured in China. Under most circumstances, this would be a laughable myth, but with this Chinese vaccine scandal, it’s important that we know where our vaccines are manufactured – spoiler alert, they are made in the USA, Europe, Canada, and Japan, all of which have strict regulation of the pharmaceutical industry. Continue reading “Chinese vaccine scandal – not a concern for USA and many other countries”

Pharmaceutical drug development – providing facts about vaccines

pharmaceutical drug development

I might be over-exaggerating, but I’ve always thought that the anti-vaccine religion believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Despite the fact that pharmaceutical drug development is so complicated and failure-prone, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device fly through this process, with Big Pharma’s lust for profits taking precedence over science.

The myths about pharmaceutical drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is 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 the process of pharmaceutical drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths of from the facts of pharmaceutical drug development.

Continue reading “Pharmaceutical drug development – providing facts about vaccines”

Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

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”

Vaccines made in China – another ridiculous anti-vax myth

Vaccines made in China

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”

Big supplement profits – making boatloads of money in the name of pseudoscience

big supplement

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.

 

Continue reading “Big supplement profits – making boatloads of money in the name of pseudoscience”

Jon Rappoport attacks GMOs and medicine – should we care?

Jon Rappoport

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?”

HHS nominee Tom Price and a radical right-wing physician organization

Tom Price HHS nominee

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”

Prevent Zika virus with GMO mosquitoes – Frankensquito returns

Prevent Zika virus – female

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”

Something’s fishy – GMO salmon is on its way

AquAdvantage GMO salmon

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”

Pharmaceutical drug development – providing facts about vaccines

pharmaceutical drug development

I might be over-exaggerating, but I’ve always thought that the anti-vaccine religion believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Despite the fact that pharmaceutical drug development is so complicated and failure-prone, I sometimes get the impression that many people think it is easy. And that any claims for a new drug or medical device fly through this process, with Big Pharma’s lust for profits taking precedence over science.

The myths about pharmaceutical drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is 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 the process of pharmaceutical drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths of from the facts of pharmaceutical drug development.

Continue reading “Pharmaceutical drug development – providing facts about vaccines”