A failed vaccine clinical trial – it happens

There is a trope that Big Pharma has an open door to push whatever drug they want onto the unwitting public, whenever they want, irrespective of any safety and effectiveness data. For those who actually work in Big Pharma, this causes more nervous laughter than any other trope, because they know how hard and complicated it is to actually do so.

I’ve written previously that less than 10% of hyped pre-clinical data ever makes it through clinical trials so that it might be considered valuable evidence for clinical decisions. And less than 10% of drugs, such as cancer treatments, ever make it from the first step through the last step (often called pivotal studies) of clinical trials to gain regulatory approval (pdf).

So if Big Pharma is lying to the public about the quality of their drugs (and by extension, vaccines), and then bribing the FDA to cover up these lies, they are laughably incompetent. I guess if they really were that inept, it’s a good thing.

But now we come to a failed vaccine clinical trial – what does that tell us about vaccine development. Continue reading “A failed vaccine clinical trial – it happens”

Big Pharma vaccine profits – the real conspiracy

Editor’s note: Note – this article has been updated and published here

One of the ongoing memes, tropes and fabrications of the vaccine deniers is somehow, somewhere, in some Big Pharma boardroom, a group of men and women in suits choose the next vaccine in some magical way, and foist it upon the world just to make billions of dollars. And while magically concocting the vaccine brew, these pharmaceutical execs ignore ethics and morals just to make a profit on hapless vaccine-injured victims worldwide.

The Big Pharma profits conspiracy trope ranges across the junk medicine world. Homeopathy, for example, claims that Big Pharma suppresses the data that shows water cures all diseases. Like Ebola.

But the Big Pharma vaccine profits conspiracy is still one of most amusing myths of the antivaccination world. Continue reading “Big Pharma vaccine profits – the real conspiracy”

Drug company withholds critical data for physician decision making

pradaxa-boxes-imageBecause I give full-throated support to the development, manufacturing and use of vaccines, one might think I was some sort of promoter of the pharmaceutical industry. In fact, I care about vaccines generically, and do not care about the system that gets vaccines into the hand of physicians. Frankly, pharmaceutical companies have the money and means to investigate new vaccines and improve old ones, which means it’s our only choice.

Maybe it would be better if the CDC or WHO were responsible for vaccines (and more or less, they are, but not for the manufacturing), but governments come and go, and there would be varying levels of support for the research. I could imagine a time where an antivaccination candidate running for US President would demand the cessation of government support of vaccine research and manufacturing, thus ending supplies of vaccines to US citizens. That would be a horrible scenario. But let’s assume that the 90-95% of Americans who vaccinate won’t vote for someone that delusional.

Pharmaceutical companies have done many wonderful things for humanity, and part of the reason we can live longer, while still being productive, is almost exclusively a result of pharmaceutical and medical innovations, especially over the past 20 years. I’m not going to list out every single revolutionary invention out of the pharmaceutical industry, but in the areas of cancer medications, antibiotics, vaccines, cardiovascular and orthopedic devices, and a few other areas, Big Medical (because it’s really more than just pharma) allows you to live longer and better. Continue reading “Drug company withholds critical data for physician decision making”

New York State updates vaccine schedule for children

If we don't vaccinate, wards of iron lungs.
If we don’t vaccinate, wards of iron lungs.

As you may be aware, there was a relatively large measles outbreak in New York City (pdf), hitting 26 individuals according to the New York City Department of Health. Some have stated that the outbreak was small, but compared to the historical average of around 60 measles cases per year for the whole United States, and when it was thought that we had “defeated” measles in the USA, 26 is a surprisingly large number.

New York City also had a 2011-12 outbreak of whooping cough (Bordetella pertussis), which was infecting individuals at nearly 4X the historical rate.

In light of these outbreaks, the New York State Department of Health (DOH) announced that it has updated its immunization requirements for school attendance to meet the revised standards recently published by Advisory Committee on Immunization Practices (ACIP), which is a group of medical and public health experts that have developed vaccine and immunization recommendations to reduce the incidence and prevent disease amongst America’s children. The goal of these recommendations is to reduce the incidence of vaccine preventable diseases.

The new 2014 standards did not add any new vaccines for school entry; however, they did update the number of doses required and the minimum intervals between doses. Generally, ACIP makes several recommendations a year, and state health departments “catch up” with the newest recommendations when they set the standard for the upcoming school year.

According to said Acting State Health Commissioner Howard Zucker, MD, JD, “immunizations protect children from serious childhood diseases, like whooping cough and measles, and have an excellent track record of safety and effectiveness. I encourage parents to talk to their children’s healthcare provider and work with their school’s health services to ensure that all immunizations are up-to-date.”

New School Immunization Requirements

The new requirements, which apply to daycare, head start, nursery, pre-kindergarten and grades kindergarten through 12, represent the best evidence and data available to public health researchers, and is the first update to the New York State requirements in over a decade.

  • Students entering kindergarten or 6th grade in the 2014-2015 school year will now be required to have two doses of the varicella (chicken pox) vaccine and 3-5 doses of poliomyelitis vaccine. The updated varicella and polio vaccination requirements will be phased in over the next seven years and will be required for all grades by the 2020-2021 school year.
  • For all other required vaccines, students in day care, head start, nursery, pre-kindergarten and grades kindergarten through 12 will be required to have age-appropriate doses in accordance with the ACIP schedule (pdf).
  • A student who is in process is defined as one who has had the first dose of vaccine in all of the required immunization series and has appointments to complete the series in accordance with the ACIP catch up schedule.
  • Students may present proof of immunity by serology (blood test) for the following immunizations: measles, mumps, rubella, hepatitis B, varicella, and poliomyelitis.
  • Medical exemptions to immunizations must be reissued annually. The written exemption must identify the immunization exempted, the medical contraindication for the exemption, and the length of time the immunization is contraindicated. A sample medical exemption form is available one the website.
  • Any child who has been vaccinated according to the ACIP recommendations, which are followed by most health care providers, should not need further vaccinations in order to attend day care or school.
Line of New York City children receiving vaccines during World War II.
Line of New York City children receiving vaccines during World War II.

New York State and City allow for legitimate medical exemptions to some or all of these vaccines, but they require certification and renewal each year. The state and city also allow religious exemptions, but recent court decisions (also here) have empowered school administrators to restrict or disallow those exemptions.

I cannot be sure that the New York State Department of Health was responding to outbreaks of measles and whooping cough to re-examine its  vaccine requirements, but it would make sense. And hopefully it, along with the reduction or elimination of nonsense religious exemptions (there are simply no legitimate anti-vaccine religious groups), will reduce or eliminate outbreaks of vaccine preventable disease.

Use the Science-based Vaccine Search Engine.

The twisted illogical gambits of the antivaccination cult

merck-vioxx-now-gardasilOK, let’s connect the dots. Merck produced and marketed Vioxx. Vioxx is bad. Merck produces and markets Gardasil. Gardasil is bad.

Yes, this is the logic of the vaccine deniers–associate Big Pharma with one of the mistakes it made in the past, then use that association to convince themselves everything produced by that Big Pharma company to be evil. This is a perfect example of the logical fallacy of Poisoning the Well, which states that one side of an argument pre-provides information that could produce a biased opinion of the reasoning, positive or negative.

Examples of this poisoning of the well abound throughout the antivaccination cults. There are numerous tired, hackneyed myths about the drug thalidomide, which, in the 1950’s was marketed by a German pharmaceutical company for the treatment of morning sickness in pregnant women (as one of its many indications). At that time, medications were not as strictly controlled as they are today for use during pregnancy, and thalidomide was given out rather freely to pregnant women. Unfortunately, nearly 10,000 children (half of them born in the former Federal Republic of Germany, also known as West Germany, but none in East Germany, because the communists did not approve it for use) were born with birth defects as a result of the drug.  Continue reading “The twisted illogical gambits of the antivaccination cult”

One hour of research on Google–obviously all science is wrong

I’ve been told that I need to quit relying on the peer-reviewed journals for my scientific knowledge, because they are paid for by Big Government, Big Pharma, Big Agra, Big Hebrew and Big Whatever. They’re all just big with every single person involved dedicated to providing information to fool the people of earth. 

Science is obviously wrong about everything. Including unicorns. Obviously wrong about unicorns.
Science is obviously wrong about everything. Including unicorns. Obviously wrong about unicorns.

Apparently, the only acceptable type of research is doing it yourself using Google. Or in a pinch, Bing. 

Because I wanted to be more open-minded and to learn the Truth™ about everything. And here’s what I found. Continue reading “One hour of research on Google–obviously all science is wrong”

Big Pharma will make a boatload of money from vaccines–good news

Money injectionAccording to a new market research report (a very expensive report hidden behind a paywall), estimate that the total vaccine market will grow from its current worldwide value of approximately US$30 billion to approximately US$100 billion in 2025. That’s an annual growth rate of approximately 10-15% for the sector compared to a 5-7% annual growth rate for all other pharmaceuticals. Still, in 2025, the total worldwide market for pharmaceuticals will be nearly US$800 billion and for medical devices (largely owned by pharmaceutical companies) nearly US$700 billion, which still makes vaccines a small part (about 7%) of the total medical products business. Continue reading “Big Pharma will make a boatload of money from vaccines–good news”

How would you treat info from a writer who was supported by Big Pharma?

I am not, nor have I ever been, a member of the Big Pharma Shill Party

The official Big Pharma Shill t-shirt.
My official Big Pharma Shill® t-shirt. Thanks to the Facebook group, Refutations to Anti-vaxx Memes. https://www.facebook.com/RtAVM

Occasionally, I receive thinly veiled questions about my integrity and ethics in the comments of various posts, in emails, or on social networking sites. Mostly, I laugh about them since they are a form of Ad hominem argument, called the Big Pharma Shill Gambit, where one side of an argument tries to dismiss the scientific evidence of another side by accusing them of being a paid mouthpiece for pharmaceutical companies. My response is generally to state that I am “polishing the gold bars stored in the basements of Big Pharma offices,” and I don’t get paid very much to do that–it’s just about the only answer worthy of the stupidity of these accusations.

The problem with actually trying to dismiss these accusations is that it’s nearly impossible to dismiss the accusations with evidence, because as we know, proving the negative is almost impossible. I could post my investment documents, and you will see that I own many shares of stock and mutual funds that invest in biotechnology and pharmaceuticals. Companies I might discuss might make up 0.1% of the holdings of the mutual fund, which means I own around 0.000000001% of a single Big Pharma company. Now, I am certainly not arrogant enough to believe that what I write has any effect on some company’s stock price, but if it did, I reap the rewards of ½¢. Woo hoo. 

Of course, even if I did post my stock holdings, someone will accuse me of hiding my 2 million shares of Merck stock in my secret offshore bank account. Which probably is in the same vault as the shiny Big Pharma gold bars.  Continue reading “I am not, nor have I ever been, a member of the Big Pharma Shill Party”

Why we vaccinate–the cost of catching the flu

Syringe with moneyThe tropes of the antivaccination horde would be laughable if it weren’t for the seriousness of the diseases that are prevented by vaccines. Even among those people who vaccinate their children for everything, they’ll make up all kinds of lame excuses for not getting the flu vaccine, all easily debunked. And someone will call you a “dumbass” if you use any of those worthless excuses. 

One of the most annoying tropes of the vaccine deniers is that somehow Big Pharma (even though some vaccines are sold by Baby Pharma) is forcing dangerous, expensive, and highly profitable vaccines on the market because Big Pharma is nothing more than greedy, unethical executives sitting in their huge offices figuring out which Ferrari they’re going to purchase next week. Setting aside the fact that most Big Pharma execs are far too conservative to drive a Ferrari, does this even make any sense whatsoever? 

Let’s get this out first. Big Pharma corporations are generally public, and as such, their shareholders expect them to make profits. But corporations don’t generate profits by turning on a cash printing machine, they must invent, develop and manufacture products, distribute it to the market, and do it well enough to actually generate profits to not only pay their shareholders, but also to invest in the next round of invention, development and manufacturing for the next set of products. Big Pharma has an extremely complex relationship with its market because bringing new products to their customers requires a huge investment in resources (from research to engineering to manufacturing). And Big Pharma has a wide variety of customers including the patient, the physician, the hospital, the insurance company (or government versions of insurance, like Medicare), the government and its regulatory arms, and many others.

Continue reading “Why we vaccinate–the cost of catching the flu”