No, childhood vaccines will not be "made from human tumors"

hela-iismall

Every so often there's an article that starts making the rounds on social media, in particular Facebook and Twitter, that cries out for a treatment by yours truly. Actually, there are more such articles that are constantly circulating on social media that I could work full time blogging and still not cover them all. So I'm stuck picking and choosing ones that either (1) particularly pique my interest; (2) irritate me enough to goad me into action; or (3) reach a level of ubiquity that I can no longer ignore them. I don't think this one's hit #3 yet, but it certainly scores on #1 and #2. Who knows? Given time, it might make #3 too, in which case a pre-emptive strike at its nonsense is definitely warranted.

I'm referring to a post on the always cranky, always misinformation-packed VacTruth.com, a website that seems to be vying to replace Age of Autism as the most wretched hive of antivaccine scum and quackery on the Internet now that AoA appears to be recycling a lot of posts for December. (One wonders if the editors are running out of writers there.) This time around, it's an article by someone named Sandy Lunoe entitled Vaccines Will be Made from Human Cancer Tumors.

Whoa. Sounds really, really scary, doesn't it?

First off, the title alone is deceptive. It's the very same gambit as the "human fetal tissue in vaccines" gambit. Just as it's not actual human fetal tissue being used to make vaccines but rather cell lines derived from a human fetus over 40 years ago, what is being proposed here is not to make vaccines out of actual human tumors but to use human tumor cell lines; i.e., cell lines derived from human tumors many years ago. Before I discuss what the FDA really discussed and did, let's take a look at Lunoe's fear mongering take on the FDA hearing of September 19, 2012:

Unbelievably, the method of producing vaccines using cells that are derived directly from human cancer tumors has been approved even though the vaccines may induce cancer in recipients. This method is cheaper and faster than breeding animals for the culture media – and human cancer tumors are readily available.

At a meeting of the Food and Drug Administration (FDA) in September 2012, the discussion which led to approval was no less than a scandal. [1]

The health authorities and vaccine manufacturers blatantly revealed their uncertainty regarding the safety of vaccines made from cancer tumors. Some of the incredible statements from the meeting are quoted directly. A more detailed account is given in this article, with statements directly quoted from the meeting in italics. [2]

Not surprisingly, how those statements are "directly quoted" reveals cherry picking and deception. For instance, let's look at the first statement from the hearing:

We have really identified three major factors that could potentially convey risk from tumor derived cells. And these include the cells themselves … and if they were tumor-derived cells then maybe they themselves could form tumors in a vaccine recipient. (Dr. K)

Now let's look at the statement in context:

We have really identified three major factors that could potentially convey risk from tumor derived cells. And these include the cells themselves. And of course, if cells were present in vaccine, they could retain their original phenotype.

And if they were tumor-derived cells then maybe they themselves could form tumors in a vaccine recipient. Although they would still be susceptible to rejection by the host immune system, and so it is unlikely that that would be a problem. But nonetheless, that is a theoretical concern.

Notice the clever use of the ellipse and how Lunoe left out the qualifications made by Phil Krause, Acting Deputy Director of the Office of Vaccines at the time, that this was a theoretical concern. The fact is that the human cancer cell lines don't generally form tumors in humans. They just don't. As Dr. Krause noted, leaving aside the fact that if any intact human cells were to remain in a vaccine product after manufacture they would be highly unlikely to be viable given the chemicals used to inactivate the viruses used (such as formaldehyde), the likelihood of a cell or handful of cells forming a viable tumor in a human muscle (which is where they would find themselves given that most vaccines are injected intramuscularly), much less going beyond that and metastasizing, are minuscule to zero. I've worked extensively with human tumor cell lines; I know them. I'm familiar with them, at least breast cancer, melanoma, and prostate cancer cell lines.

Moreover, it's not difficult to use manufacturing steps to make sure that all viable cells are removed, as Dr. Krause himself also notes later in the article, pointing out that the "cells themselves aren’t a real concern, because we are sure that they are all removed." It really isn't that difficult.

Of course, that leaves other concerns that are not quite as fantastical as tumors, but still a bit of a stretch. In fact, that the FDA discussed and investigated these possibilities so thoroughly, as demonstrated in its report (linked to in the article and found here as a Scribd document). Krause describes them:

Cell DNA also is a theoretical concern, both because cell DNA could contain infectious genomes -- and we know that DNA can be picked up by cells and that then could lead to initiation of an infection -- as well as a theoretical oncogenic risk. And then there is the question of adventitious agents.

There are several ways in which tumor derived cells might lead to an increased adventitious agent risk, potentially an increased risk due to more passages in history of the cell, as the cell line was developed. Potential ability of a cell substrate to support the growth of additional viruses, but probably most relevant to the discussion in the potential for a virus to have been involved in tumor development in the first place, because that is one of the differentiating factors of these cells with other cells.

In other words, tumor cell lines really aren't that different from fetal cell lines already used to make vaccines. The one difference is that they might harbor viruses that originally led to the formation of the cancer from which the cell lines were derived.

It's important to remember right here that the cell lines that were being considered for use as substrates in which to grow viruses are:

  • A549 cells: A lung cancer cell line. It was derived from a 58 year old Caucasian male with lung cancer associated with smoking. Its dominant mutation has been identified as KRAS. (You don't need to know the details.)
  • HeLa cells: You've probably heard of this cell line before. It was derived from a woman named Henrietta Lacks with cervical cancer back in the 1950s, and its development was the topic of a recent bestseller. It's one of the oldest established cancer cell lines still in use. Now, cervical cancer is indeed usually caused by human papilloma virus, it's true. In Lacks' case, it was HPV type 18. It is known. (Sorry, couldn't resist.)

Basically, a company called PaxVax has been experimenting with the use of A549 cells as a substrate to grow virus to make vaccines against pandemic influenza, anthrax, and HIV, using various strategies. The primary advantage the company finds is greatly increased yield of virus compared to other methods of growing the virus. For example, the yields gained from A549 cells were 10- to 40-fold higher than they were from MRC-5 cells, one of the fetal cell lines commonly used to grow virus for several vaccines.

Rebecca Sheets, an investigator at the NIH—specifically National Institute of Allergy and Infectious Diseases (NIAID)— then described investigations into the use of HeLa cells as a substrate to develop HIV vaccines. The reasons were similar: High yields. But she also described another potential benefit of using tumor-derived cell lines that might not be so obvious, at least not to lay people. First, however, you have to understand the difference between primary cells and cell lines. Primary cells are cells grown in culture after having been directly isolated from an organism. Human foreskin fibroblasts, isolated from—yes, and yuck—discarded foreskins from circumcisions, are commonly used primary cell lines. The advantages of primary cell lines is that they are more like "normal" than cell lines. The key disadvantage of them, however, is that they only replicated a limited number of times and therefore, as they are passaged in culture they undergo senescence and stop growing. Cell lines, on the other hand, can divide indefinitely. Unfortunately, even cell lines that don't form tumors have to undergo genetic changes of one sort or the other in order to acquire immortality (the ability to replicate indefinitely without becoming senescent).

Primary cell lines have been used to make vaccines, but they have a huge disadvantage, as you might imagine. That's why Sheets pointed out that the use of cell lines could actually decrease the risk of infection due to adventitious agents (agents that happen to be in the cells):

And now we are poised to consider tumor-derived cell lines such as the A549 cell line that you heard from PaxVax earlier, and HeLa cells, which I am going to tell you about now. So over time, primary cells, while still in use, have really fallen out of favor because they cannot be banked and well-characterized prior to use in production, and they must be sourced each time. So there is always that risk of introducing an adventitious agent from the primary source. Whereas, cell lines can be banked. They can be thoroughly and exhaustively tested prior to their use in production. And therefore, just the use of a cell bank can lower your risk of adventitious agent contamination.

So what has really driven this evolution? I think in large part we have a much better understanding of cell biology and the molecular basis of cancer than we did 60 years ago. We certainly have better tools to characterize cells and to characterize products. We have a greater experience with the various different cell lines, including a lot of experience from the veterinary field, as well as the biotech therapeutics field that the vaccines, human vaccines field, can trade on.

And that's a huge difference from 60 years ago. Lunoe, not surprisingly, brings up a favorite bugaboo of antivaccinationists, namely the contamination of polio virus with SV40. I've discussed this unfortunate history extensively before. Suffice to say, there's never been any good evidence that contamination with SV40 caused any cancers, but, more importantly, 60 years ago we had no clue how to detect viruses like SV40 reliably. Today not only can we detect SV40 at extremely low copy numbers, but we can sequence it and tell exactly what its origin was. Moreover, we understand far more about how cancer develops, as Dr. Sheets pointed out:

We know now that tumors arise from genetic changes that result in inappropriate expression or knock out of what started as a proto-oncogene and might get turned into an oncogene. In other words, cancer is in the DNA. Viruses that cause cancer often express proteins that interact with cellular oncoproteins or which are themselves oncoproteins. And so again, it is in the nucleic acid of the virus as well that encodes these oncoproteins. We also know now how to more carefully measure cell residuals in products. For example, how to measure host cell nucleic acids and host cell proteins, which in traditional vaccines were not measured.

We have improved methods for detection of viruses and viral nucleic acids, and we also have improved purification processes to remove or destroy cell residuals in viruses that might have been present. And I should add that we now operate more in an era of current good manufacturing practices, which was not in place in the 1950s and 1960s.

So what about DNA contamination? I've discussed in detail why it's incredibly unlikely that any vaccine would contain sufficient DNA from the cells in which its virus was grown to have a significant effect on the organism to which the vaccine is administered, much less to cause cancer. Indeed, Sheets points out that residual host cell DNA from a vaccine preparation was assessed by PCR for the human papilloma virus that caused the transformation of HeLa, pointing out that the lower limit of detection of the assay was 25 copies per ml. The total cellular DNA measured was approximately 60 picograms (thats 10-12 grams) per dose of vaccine, which is extremely low. In addition, Benzonase® Nuclease is used to digest DNA in the manufacturing process, so that any fragments of the oncogene from HPV are digested to unmeasurable levels.

The FDA even considered the possibility of bovine spongiform encephalopathy (BSE), a disease caused by prions, given that fetal bovine serum or calf serum are commonly used in the cell culture media used to grow the cells. Prions are abnormal pathogenic agents that are transmissible. They cause encephalopathy by inducing abnormal folding of certain normal cellular proteins found most abundantly in the brain. They are the cause of so-called "mad cow disease," and can therefore be transmitted by consuming beef. It's a long shot, but the fact that scientists consider the possibility of prion diseases, to the point that they discuss the feasibility of growing these cell lines in serum-free medium, shows just how cautious they are.

When you come right down to it, Lunoe's strategy is obvious: Cherry pick the most damning parts of the discussion that are only damning when taken out of context, as Lunoe does, all to make it sound as though the scientists and regulators of the FDA and NIH were trying to pull a fast one or were insufficiently concerned about safety in considering the use of A549 or HeLa cells as substrates in which to grow viruses for vaccines, when in fact the totality of the transcript reveals just the opposite: Endless discussion of whether DNA from such vaccines could cause tumors (highly unlikely), complete with even more discussion of tests to make sure that any possible DNA that might conceivably cause a tumor is purged from the final vaccine, up to and including animal carcinogenicity tests, about which, by the way, the scientists also argued about, in particular whether they needed to watch the animals longer to rule out any tumorigenicity. In other words, contrary to the impression given by Lunoe, the entire tone of the hearing was one of hyper-caution, of considering all possibly ways in which harm might be caused by using human tumor cell lines as substrate to grow virus for vaccine.

Not surprisingly, the scientists were worried about whether or not the public would accept vaccines made from human tumor cell lines, and Lunoe made sure to quote these deceptively. For instance, according to Lunoe quoting Marion Gruber, Director of the Office of Vaccines at the FDA:

The minute you describe something in the package insert in terms of potential clinical safety concerns, I think that really precludes using these cell substrates.

From this, she claims that the FDA was plotting to leave the identity of the cells used off the package insert. Now here's the quote in context:

The quote in context:

I would like add to this -- it goes back to the earlier point I made -- I think the minute that we think that we have to address any of these concerns in the clinic, we would not be using -- we would be very reluctant for a cell substrate such as these cells to be used for vaccine production, if we are not reasonably assured that the characterization done, as we have discussed today, is adequate. The minute you describe something in the package insert in terms of potential clinical safety concerns, I think that really precludes using these cell substrates.

That I don’t think we would really elaborate on in a package insert, because these things should be thoroughly tested and evaluated in establishing the manufacturing process. In our review of the data, we will have to have come to the conclusion that these cells are safe for use for vaccine production.

It's a rather different implication, don't you think?

Lunoe then quotes Jim Cook, Director of Infectious Disease at Loyola Medical Center in Chicago, and co-director of the Infectious Disease and Immunology Institute:

When it gets right down to what’s in the vial and what the patient is going to ask me about, whether it’s safe, I’m not going to say, well, you know, HeLa cells kill nude mice.

Wow. Sounds really bad, doesn't it? Well, not really. Not in context:

I’m not a regulator, so I will say just what I think in reaction to the comment about putting comments in a package insert about tumor cells making tumors in which vaccines were made. I would say, from a personal opinion, that you would have to be very careful about the degrees of separation between where the stuff comes from and what you are putting in the vial that the package insert is describing. It’s not at all related, in a certain sense. I’m not 100 percent convinced that whether or not a cell makes a tumor in a nude mouse has anything to do with the safety of a vaccine that ends up getting made. There are concerns we have. It’s a really interesting intellectual discussion. When it gets right down to what’s in the vial and what the patient is going to ask me about, whether it’s safe, I’m not going to back and say, well, you know, HeLa cells kill nude mice.

It’s not a very good analogy, but think about what we do in terms of making bacterial toxins or preparations related to that. You don’t want to go to somebody and say, “You know, botulinum kills people. It can paralyze you. It’s really dangerous,” or, “Anthrax kills people,” when you are trying to make some kind of an antibody against protective antigen or lethal factor.

The degrees of separation between what is being used to make it and what the product is in the vial have to be considered when you are talking to the lay person, or they are going to get completely confused and refuse to use anything. They do that already. They come in with a PDR. You can imagine how it is trying to tell them what to do.

So I would be very careful about that.

All of this represents a reasonable, measured response to questions about what to put on the package insert, making an analogy to other biological products that are potentially dangerous or were derived using biological techniques that sound scary or just yucky and what is put on their package inserts. The point, of course, is that scientists know that antivaccinationists like the crew at the Orwellian-named VacTruth.org and other sites will do exactly what Sandy Lunoe did: Quote mine, cherry pick, exaggerate dangers, and do everything to make it seem as though scientists are reckless ideologues who don't care about safety.

People like Sandy Lunoe demonstrate why people like Drs. Gruber and Cook are concerned about what goes on package inserts. They have good reason to be concerned, because they know the Lunoes of the world will do their best to twist anything they say and use fear to convince people that any vaccine made using a cancer cell line is too dangerous.

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Thank you so much for addressing this highly misleading article that somehow went viral on Facebook! As usual, there's a drop of truth in a sea of deception.

HeLa cells kill nude mice.

To expand on this at the attention of any passerby, a nude mouse is a variety of lab mouse with an inactivated immune system. It has to be kept in a germ-free environment.
In other words, it has little or no protection against bacteria and viruses and, in the context of this post, against would-be tumor cells.

Thus the point of the CDC director, Jim Cook, talking about nude mice: it's unfair, if not plain wrong, to use as a yardstick the lethal effect of Hela cells in mice which don't have a chance to defend themselves against the invaders. Mice - and humans - with a working immune system could be reliably expected to fare much better, as Orac pointed out at the start.

That's assuming that these vaccines will contain live Hela cells (or whatever line was used) to start with. If the vaccine manufacturers do a good job at preparing the product, then it's even more unfair to talk about Hela cells and nude mice, since live cells will not be present in the final product and humans are not nude mice.
Hence Jim Cook insisting on the degrees of separation.

What if a human is similarly lacking an immune system in good working order?
For one thing, you will very likely know about it, with you catching every mundane bug floating in your vicinity, and you will know which vaccines are not for you (ask your doctor).
For another thing, you will have worse things to worry about than vaccines. Like keeping your environment germ-free (asking people around you to vaccinate themselves would help).

By Helianthus (not verified) on 02 Dec 2014 #permalink

I suppose Lunoe would have a heart attack if she knew that I'm involved in a pilot study into generating antibodies using cultured insect cells (Sf9 and Sf21) infected with baculovirus. These antibodies will be injected therapeutically into animals, initially, but there's enough value in human therapeutics to make it a likely next step.

Ironically, insect cell production of protein is actually safer for human injection because of the very risks being discussed here.

By c0nc0rdance (not verified) on 02 Dec 2014 #permalink

There are some scientists here at Arizona State University who have developed strain(s)of live, attenuated Salmonella bacteria being tested for vaccine delivery. The work sounds very promising. The researchers have already started working on separate research regarding how to handle the AV backlash they know they are going to get if their system comes to FDA approval, see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4129221/

By Chris Hickie (not verified) on 02 Dec 2014 #permalink

@ Dr. Chris: What a coincidence that you link to research into the S. typhi bacterium for vaccine(s) delivery, completed at Arizona State University in conjunction with a researcher from the University of Bergen (Norway).

Sandy Lunoe is one of those cranks who hangs out at SaneVax spreading her pseudoscience to the credulous ignorati about vaccine components...especially the scary rDNA virus vaccines. Lunoe really has "arrived" with her own entry on whaleDOTto.

The HeLa cell story sounds hella cool.

@BA - I highly recommend it, too. The biotech company I used to work for created a medium optimized for that cell line, and I learned a bit of her story almost ten years before the book while writing the training materials. When I saw the book advertised I immediately got a copy.

I have ordered a copy. Can't wait for the semester to end so I can dig in.

I worked in a lab once where we used HeLa cells to grow our virus (for gene therapy, oh, scary). One day there was a problem with a pump on the 100L bioreactor full of HeLa cells and one of my co-workers caught it in the face (around his face shield). He was ... fine.

One would note that in addition to lacking an immune system, nude mice also lack hair, and are frankly, pretty hideous.

By JustaTech (not verified) on 02 Dec 2014 #permalink

Tumor and insect based cells making vaccines? Cool! Would Henrietta Flacks be a good start to for a layman to learn about cell lines? Any other recommendations?

By e canfield (not verified) on 02 Dec 2014 #permalink

*Lacks* oops

By e canfield (not verified) on 02 Dec 2014 #permalink

The Immortal Life of Henrietta Lacks would be a good introduction to cell lines, mostly because the author had to explain them to her family.

It is not only a story about science, it is also a story about a family and how medical ethics have evolved over the past sixty or so years.

By the way, I started reading the book on a lazy Sunday morning. I finished it by dinner time, which is when I finally changed out of my jammies.

It is a page turner.

Agreed, Chris. Very good book.

Two things always amaze me about HeLa cells. Firstly, a few decades ago it was found they had contaminated and infiltrated hundreds of cell cultures around the world, due to their resilience, and lot of research proved worthless as a result*. It almost led to an international incident between the US and the USSR. The second is that more than 20 tons of HeLa cells have been cultured to date. It's a weird way of becoming immortal.

* Or so I have read; as far as I know this is true.

By Krebiozen (not verified) on 02 Dec 2014 #permalink

To expand on this at the attention of any passerby, a nude mouse is a variety of lab mouse with an inactivated immune system.

I prefer my version.

Firstly, a few decades ago it was found they had contaminated and infiltrated hundreds of cell cultures around the world, due to their resilience, and lot of research proved worthless as a result

Careful, there's a remote chance that Kent Heckenlively might figure this out.

@ Shay

I prefer my version

Where can I read it?

By Helianthus (not verified) on 03 Dec 2014 #permalink

Nude mice are cute, not hideous--Just like naked mole rats.

I think scientists should inject themselves and other zealous co-workers and pro-vaxers FIRST!

Until you can explain to me why you put 250 mg's of aluminum in a HepB shot given to an infant on day one of birth when the known toxic dose is 20 mg's I will not presume that any vaccine should be trusted!

So is it bogus that 14 senior citizens died in the same senior center after flu shots were given?

Until you can explain to me why you put 250 mg’s of aluminum in a HepB shot given to an infant on day one of birth when the known toxic dose is 20 mg’s I will not presume that any vaccine should be trusted!

The explanation is quite simple: you're innumerate. There are 0.25 milligrams of Al³⁺ in a dose of Engerix-B.

^ Whoops, that's 0.25 mg of Al(OH), so there would be 0.09 mg of Al³⁺, if aluminum hydroxide weren't insoluble at physiological pH.

Ah, I should have known: Kathy's toxicity figure comes from none other than Bob Sears.

Nice to see that the actual post was about JeffyJohn Hair Product Aufdenheide, who (wisely) pretty much hides in his VacTwoof hole, which lately seems to have become the abode of Lowell Hubbs, and I'll say that it's awfully White of him to be mainly sticking to irritating the choir.

why you put 250 mg’s of aluminum in a HepB shot

It's impossible to diagnose your problem: it could be innumeracy (as narad suggests), ordinary illiteracy, plain laziness, ignorance, or prevarication. The amount of Al(OH)₃ (Aluminum Hydroxide, not pure aluminum) in question is 250 μg, (often rendered as 250 mcg by those who can't [be bothered to] find the mu on their keyboard or in their character map program). 250 mg (milligrams) is 1000 times as much as 250 μg (micrograms).
The correction from Al(OH)₃ to Al³⁺ ions, as narad points out, further corrects your question to

why you put 90 micrograms of aluminum in a HepB shot...when the known toxic dose is 20 mg[]s

The answer to your question, as corrected, involves 9/2000 of your claimed toxic dose...

By Bill Price (not verified) on 04 Dec 2014 #permalink

I think this is my favorite part of the "Dr. Bob" entry:

If I could sum up the aluminum controversy in three sentences, it would be this. There is good evidence that large amounts of aluminum are harmful to humans. There is no solid evidence that the amount of aluminum in vaccines is harmful to infants and children. No one has actually studied vaccine amounts of aluminum in healthy human infants to make sure it is safe. Should we now stop and research this matter? Or should we just go on and continue to hope that it is safe?

There's simply no legitmate argument that the last two aren't part of the summation of the "aluminum controversy"; they are "the controversy."

The explanation is quite simple: you’re innumerate. There are 0.25 milligrams of Al³⁺ in a dose of Engerix-B.

F***in' decimals, how do they work?
/ICP

@ Bill Price

often rendered as 250 mcg by those who can’t [be bothered to] find the mu on their keyboard or in their character map program

To be fair, the µ was not present on keyboards for those of us using computers before the 90"s, and inserting a "m" letter after setting the keyboard on the greek alphabet proved to be very unwise: at the first occasion, all you text got reformatted to standard alphabet and your poor "µ" reverted back to a "m", with very embarrassing consequences.
We old timers may need a brain update, but we have some reason of being used to the mcg notation.

That being said,

why you put 250 mg’s of aluminum in a HepB shot

A typical vaccine is about 0.5 to 1 ml in volume, or 0.5 to 1 g in content. Trying to pack 250 mg of mineral salts in so little a volume and still expect to be able to inject it through a narrow needle is an exercise in futility.
It would put it on par with the salinity of the dead sea.

By Helianthus (not verified) on 04 Dec 2014 #permalink

We old timers may need a brain update, but we have some reason of being used to the mcg notation.

Helianthus, as an old-timer* myself, I'm well aware of keyboards without even the m character**, much less the µ. That's why "can’t [be bothered to] find" has a significant portion in the regex/EBNF 'occurs 0 or 1 times' brackets: the absence of a µ key seems ample justification for being unable to find it. ;-)
--------------------------------------------------------------------------------
* possibly also in need of a brain update.

** Fifty years ago, the 6-bit 'puters I dealt with, and their associated keyboards & such, didn't cater to lower-case letters, much less mixed Latin and Greek characters sets.

By Bill Price (not verified) on 04 Dec 2014 #permalink

the 6-bit ‘puters I dealt with, and their associated keyboards & such, didn’t cater to lower-case letters

Upper case was GOOD ENOUGH FOR YAHWEH.

By herr doktor bimler (not verified) on 05 Dec 2014 #permalink

This is engraved permanently on my brain: (ALT + 230) = µ so it might be useful for others.

People getting milligrams and micrograms mixed up is a major part of antivaccine mythology. I have seen it on regard to mercury and formaldehyde (and various other 'toxins') as well as aluminum.

By Krebiozen (not verified) on 05 Dec 2014 #permalink

Unsurprisingly, "250 mg's of aluminum" is something of an uncommon phrase.

Fifty years ago, the 6-bit ‘puters I dealt with, and their associated keyboards & such, didn’t cater to lower-case letters

Ahem.

"Optional ROMs were available for APL as well as Katakana and other character sets."

I once had to part with two of these that I yearned to turn into a dining table that would preserve the original functionality.

I'm wondering if anyone knows the origin of Kathy's "14 seniors died in the same senior center after flu shots" idea. A cursory search showed a story along that vein but a) it was 5, not 14, b) it was an assissted care center, not a senior center (that's a MAJOR difference) and c) the source that "broke" the "story" published an "update" that essentially says "Oh, sorry guyz, we heard some rumors and we printed the rumors and it turns out that the rumors were false - but, see, it's their fault because they didn't do ENOUGH to stop us running with a story we had no factual support for." h--p://healthimpactnews.com/2014/6-seniors-die-after-flu-shot-at-assisted-care-center-in-georgia/

By Antaeus Feldspar (not verified) on 05 Dec 2014 #permalink

So is it bogus that 14 senior citizens died in the same senior center after flu shots were given?

Imma go out on a limb here, kathybates77, and say "yes".

By herr doktor bimler (not verified) on 05 Dec 2014 #permalink

Health Impact News has issued this statement from the assisted care facility...where Health Impact News reported five deaths, supposedly from receiving seasonal influenza vaccine

"All residents of Hope Assisted Living & Memorial Care did not receive flu shots on November 7, 2017. The only residents receiving the flu shots were done with the consent of the resident and his or her family. None of the residents receiving shots developed fevers or died. The only residents at Hope Assisted Living & Memorial Care who died during the period from November 7, 2014 to November 17, 2014, were hospice patients who did not receive flu shots. (apparently typo on year in original) "

That same bogus report was featured on Natural News.

Good article. We've produced vaccines in animal lines for decades and they are continually vetted for occult agents like simian virus. I guess that would be even more fodder for their nonsense. You'd think they'd be in favour of saving the monkeys and other animals that are sacrificed - but they are just opposed to vaccination period regardless of scientific reasoning.

I can't find an author's name on this article? Who is the author and what is their expertise. This is really important to me when assessing material.

@ C. Hurd

I can’t find an author’s name on this article?

If you mean the author of this blog, check the little pseudonym in blue at the top of the page, right under the title of this thread.
Starting from it, you should be able to find out what the real name of the author is.
If you need more clues, check the other threads.

By Helianthus (not verified) on 06 Dec 2014 #permalink

C. Hurd: "I can’t find an author’s name on this article?"

Have you tried looking under the title for the link after the words "Posted by"?

It seems many are failing the simple intelligence test of figuring out what the words "Posted by" mean, and how to realize the blue words are a link to another URL.

The writers for this "science" blog are always grossly misleading the public on issues from "natural news".
here is a LINK THAT SAYS THEY ARE TRYING OUT VACCINES WITH TUMOR CeLLS !! They are not hiding it but proud of it. My friend is in the program at Dartmouth!
http://dartmed.dartmouth.edu/spring11/html/disc_trial.php

Plus- your other article on vaccines from the CDC- maybe they did not 'APOLOGIZE" but on national news they did say- sorry they current vaccines are very effective this year and may only be 40% effective so please get your shots anyway.
article here on CBS:
http://www.cbsnews.com/news/flu-shot-may-not-be-enough-protection-this-…

and CNN:
http://www.cnn.com/2014/12/04/health/flu-vaccine-mutated-virus/

You cannot try to be "science" when you are obviously pushing your pro-vaccine agenda at any cost and grossly misleading the public.

here is a LINK THAT SAYS THEY ARE TRYING OUT VACCINES WITH TUMOR CeLLS !!

Maybe you should read the bloody link before flipping out. This has nothing to do with vaccines against infectious disease.

Michelle - Is Dartmouth's vaccine against cancer likely to become a childhood vaccine? If not, in what way does that relate to Orac's post?

Also, does it come as a surprise that an anti-cancer vaccine would be made using cancer cells?

If you had read what Orac wrote in his post on influenza, you'd find that he also notes that this year's vaccine will not be fully effective against all circulating strains. However, since there are always multiple influenza strains in the environment, it will protect you against some of them.

By Mephistopheles… (not verified) on 07 Dec 2014 #permalink

but… this study says they used cancer cells…

Excellent. The idea that anti-cancer vaccines can be made from cancer cells has of course been around for years.

I used to work with a fellow who was expected to die within the year when his melanoma metastasized. Because of its location, the surgeon wasn't able to completely excise the most prominent met, and there were doubtless many other smaller tumors. The surgeon saved some of the excised tumor and gave it to his patient, his good friend, who ground it up, mixed it with adjuvent, and injected it as his personal form of immunotherapy--and enjoyed a healthy and very productive life for three more decades.

Maybe you should read the bloody link before flipping out. This has nothing to do with vaccines against infectious disease.

Even better, it's not even a vaccine, in the usual sense. All the contacts between the immune cells and the nasty tumor cells happen outside of the patient.

If I understood correctly, they are picking up cancer cells from the patient's tumor and white blood cells from his/her blood (actually, specific cells whose function is to degrade proteins and then present the fragments to other white cells in order to recruit them into killing the intruders, a wanted poster as the author put it)
Then they mix both these cells together so they can get properly introduced (actually, the cancer cells are already dead - the scientists are feeding the carcasses of the cancer cells to the white blood cells).
And then they re-inject the white blood cells into the patients, loaded to the gills with fragments of the tumors cells in order to wake up the other cells of the immune system and send them hunting-killing.

Brilliant!

By Helianthus (not verified) on 07 Dec 2014 #permalink

here is a LINK THAT SAYS THEY ARE TRYING OUT VACCINES WITH TUMOR CeLLS !!

That makes about as much sense as a response to Orac's article as if he wrote "no, we are not likely to be invaded by extraterrestrial aliens" and you "rebutting" it with an article about snakeheads and other invasive fish species.

By Antaeus Feldspar (not verified) on 07 Dec 2014 #permalink

The writers for this “science” blog are always grossly misleading the public on issues from “natural news”.

In particular, "they" have managed to mislead Michelle into thinking that Orac is some sort of plural entitiy.

By herr doktor bimler (not verified) on 07 Dec 2014 #permalink

Warning. One HeLava cut-'n'-paste (sorry <-- not really):

The New York Times OP-ED Section
Sunday, March 19, 2006

Author's Note

At the end of my research for this book, I arrived at the following conclusions:

1. Stop patenting genes. Gene patents might have looked reasonable twenty years ago, but the field has changed in ways nobody could have predicted. Today we have plenty of evidence that gene patents are unnecessary, unwise, and harmful.

There is great confusion about gene patents. Many observers conflate a call to end gene patents with anticapitalist and anti-private property sentiments. It is nothing of the sort. It is perfectly reasonable for industry to seek a mechanism that will ensure a profit on productive investment. Such a mechanism implies a restriction on competition involving a created product. However,
such protection doesnot imply that genes themselves should be patented. On the contrary, gene patents contradict long-established traditions of intellectual property protection.

First, genes are facts of nature. Like gravity, sunlight, and leaves on trees, genes exist in the natural world. Facts of nature can't be owned. You can own a test for a gene, or a drug that affects a gene, but not the gene itself. You can own a treatment for a disease, but not the disease
itself. Gene patents break that fundamental rule. Of course one can argue about what's a fact of nature, and there are people paid to do that. But here's a simple test. If something exists for millions of years before the arrival of Homo sapiens on earth, it's a fact of nature. To argue that a
gene is in any way a human invention is absurd. To grant a gene patent is like granting a patent on iron or carbon.

Because it's a patent on a fact of nature, a gene patent becomes an undeserved monopoly. Ordinarily, patent protection enables me to protect my invention but encourages others to make their own versions. My iPod doesn't prevent you from making a digital audio player. My
patented mousetrap is wood, but your titanium mousetrap is allowed.

This is not what happens with gene patents. The patent consists of pure information already existing in nature. Because there has been no invention, no one can innovate any other use of the patent without violating the patent itself, so further innovation is closed. It's like allowing somebody to patent noses. You couldn't make eyeglasses, Kleenex, nasal sprays, masks, makeup, or perfume because they all rely on some aspect of noses. You could put suntan lotion
on your body, but not on your nose, because any modification of your nose would violate the patent on noses. Chefs could be sued for making fragrant dishes unless they paid the nose royalty. And so on. Of course, we would all agree that a patent on noses is absurd. If everyone has one, how can anyone own it? Gene patents are absurd for the same reason.

It takes little imagination to see that monopolistic patenting inhibits creation and productivity. If the creator of Auguste Dupin could own all fictional detectives, we would never have had Sherlock Holmes, Sam Spade, Philip Marlowe, Miss Marple, Inspector Maigret, Peter Wimsey,
Hercule Poirot, Mike Hammer, or J. J. Gittes, to name just a few. This rich heritage of invention would be denied us by a patenting error. Yet that is exactly the error in patenting genes.

Gene patents are bad public policy. We have ample evidence that they hurt patient care and suppress research. When Myriad patented two breast cancer genes, they charged nearly three thousand dollars for the test, even though the cost to create a gene test is nothing like the cost to develop a drug. Not surprisingly, the European patent office revoked that patent on a technicality. The Canadian government announced that it would conduct gene tests without paying for the patent. Some years ago, the owner of the gene for Canavan disease refused to make the test widely available, even though families who had suffered with the disease had contributed time, money, and tissues to get the gene identified. Now those same families could
not afford the test.

That is an outrage, but it is far from the most dangerous consequence of gene patents. In its heyday, research on SARS (Severe Acute Respiratory Syndrome) was inhibited because scientists were unsure who owned the genome — three simultaneous patent claims had been filed.
As a result, research on SARS wasn't as vigorous as it might have been. That should scare every sensible person. Here was a contagious disease with a 10 percent death rate that had spread to two dozen countries around the world. Yet scientific research to combat the disease was
inhibited — because of patent fears.

At the moment, hepatitis C, HIV, hemophilus influenza, and various diabetes genes are all owned by some entity. They shouldn't be. Nobody should own a disease. If gene patents are ended, we can expect screams of outrage and threats that business will abandon research, that companies will go bankrupt, that health care will suffer and the public will die. But it is more likely that an end to gene patents will be phenomenally liberating to everyone, and will result in a burst of new products for the public.

2. Establish clear guidelines for the use of human tissues. Human tissue collections are increasingly important to medical research, and increasingly valuable. Appropriate federal regulations to manage tissue banks already exist, but courts have ignored federal rules. Historically, the courts have decided questions about human tissues based on existing property law. In general, they have ruled that once your tissue leaves your body, you no longer maintain any rights to it. They analogize tissues to, say, the donation of a book to a library. But people have a strong feeling of ownership about their bodies, and that feeling will never be abrogated by a mere legal technicality. Therefore we need new, clear, emphatic legislation.

Why do we need legislation? Consider a recent court ruling on the case of Dr. William Catalona. This eminent prostate cancer physician assembled a collection of tissue samples from his patients so he could work on the disease. When Dr. Catalona moved to another university, he tried to take the tissues with him. Washington University refused, saying that it owned the tissues; the judge upheld the university, citing such trivial facts as some of the releases' being printed on Washington University stationery. Patients are now understandably outraged. They believed they were giving their tissues to a beloved doctor, not a shadowy university lurking in the background; they thought they were giving tissues specifically for prostate cancer research, not for any use, which the university now claims the right to do.

The notion that once you part with your tissue you no longer have any rights is absurd. Consider this: Under present law, if somebody takes my picture, I have rights forever in the use of that photo. Twenty years later, if somebody publishes it or puts it in an advertisement, I still have
rights. But if somebody takes my tissue — part of my physical body — I have no rights. This means I have more rights over my image than I have over the actual tissues of my body.

The required legislation should ensure that patients have control over their tissues. I donate my tissues for a purpose, and that purpose only. If, later, someone wants to use them for another purpose, they need my permission again. If they can't get permission, they can't use my tissues.

Such a rule fulfills an important emotional need. But it also acknowledges that there may be significant legal and religious reasons why I do not want my tissue used for another purpose.

We should not fear that such regulations will inhibit research. After all, the National Institutes of Health seems to be able to conduct research while following these guidelines. Nor should we accept the argument that these rules impose an onerous burden. If a magazine can notify you that your subscription has run out, a university can notify you if they want to use your tissues for a new purpose.

3. Pass laws to ensure that data about gene testing is made public.New legislation is needed if the FDA is to publish adverse results from gene therapy trials. At the moment, it cannot do so. In the past, some researchers have tried to prevent the reporting of patient deaths, claiming that such deaths were a trade secret.

The public is increasingly aware of defects in the systems we use to report medical data. Research data has not been made available for other scientists to inspect; full disclosure has not been required; genuinely independent verification of findings is rare. The result is a public
exposed to untold unknown hazards. Bias in published studies has become a bad joke. Psychiatrist John Davis looked at the trials funded by pharmaceutical companies in competition for the most effective of five different antipsychotic drugs. He found that 90 percent of the time, the drug manufactured by the company sponsoring (paying for) the study was judged superior to the others. Whoever paid for the study had the best drug.

This should not be news. Review studies conducted by those who have a financial or other interest in the outcome are not reliable because they are inherently biased. That fact should be addressed by an information system that does not permit biased testing, and takes steps to ensure
that it does not occur. Yet gross bias remains far too common in medicine, and in certain other areas of high-stakes science as well.

Government should take action. In the long run there is no constituency for bad information. In the short run, all sorts of groups want to bend the facts their way. And they do not hesitate to call their senators, Democratic or Republican. This will continue until the public demands a change.

4. Avoid bans on research. Various groups of different political persuasions want to ban some aspect of genetic research. I agree that certain research ought not to be pursued, at least not now. But as a practical matter, I oppose bans on research and technology.

Bans can't be enforced. I don't know why we have not learned this lesson. From Prohibition to the war on drugs, we repeatedly indulge the fantasy that behavior can be banned. Invariably we fail. And in a global economy, bans take on other meanings: even if you stop research in one
country, it still goes on in Shanghai. So what have you accomplished?

Of course, hope springs eternal, and fantasies never die: various groups imagine they can negotiate a global ban on certain research. But to the best of my knowledge, there has never been a successful global ban on anything. Genetic research is unlikely to be the first.

5. Rescind the Bayh-Dole Act. In 1980, Congress decided that the discoveries made within universities were not being made widely available, to benefit the public. To move things along, it passed a law permitting university researchers to sell their discoveries for their own profit, even when that research had been funded by taxpayer money.

As a result of this legislation, most science professors now have corporate ties — either to companies they have started or to other biotech companies. Thirty years ago, there was a distinct difference in approach between university research and that of private industry. Today the
distinction is blurred, or absent. Thirty years ago, disinterested scientists were available to discuss any subject affecting the public. Now, scientists have personal interests that influence their judgment.

Academic institutions have changed in unexpected ways: The original Bayh-Dole legislation recognized that universities were not commercial entities, and encouraged them to make their research available to organizations that were. But today, universities attempt to maximize profits
by conducting more and more commercial work themselves, thus making their products more valuable to them when they are finally licensed. For example, if universities think they have a new drug, they will do the FDA testing themselves, and so on. Thus Bayh-Dole has,
paradoxically, increased the commercial focus of the university. Many observers judge the effect of this legislation to be corrupting and destructive to universities as institutions of learning.

Bayh-Dole was always of uncertain benefit to the American taxpayers, who became, through their government, uniquely generous investors. Taxpayers finance research, but when it bears fruit, the researchers sell it for their own institutional and personal gain, after which the drug is
sold back to the taxpayers. Consumers thus pay top dollar for a drug they helped finance.

Ordinarily, when a venture capitalist invests in research, he or she expects a significant return on investment. The American taxpayer gets no return at all. The Bayh-Dole legislation anticipated that the public would receive a flood of marvelous life-saving therapies such that the investment
strategy would be justified. But that hasn't happened.

Instead, the drawbacks far outweigh the benefits. Secrecy now pervades research, and hampers medical progress. Universities that once provided a scholarly haven from the world are now commercialized — the haven is gone. Scientists who once felt a humanitarian calling have
become businessmen concerned with profit and loss. The life of the mind is a notion as quaint as the whalebone corset.

All these trends were perfectly clear to observers fifteen years ago; no one paid much attention back then. Now the problems are becoming clear to everyone. A good first step toward restoring the balance between academia and corporations will be to repeal Bayh-Dole legislation.

-- Michael Crichton, Next

Thank you so much as always for your synthesis of sources, expert opinion, and indefatigable efforts to educate! I wonder if you have time to sleep??!?! I found this very helpful to intelligently answer questions from patients suddenly asking me if flu shots cause cancer.

By drcharles (not verified) on 17 Jan 2015 #permalink

LOL, nude mice are used as the primary model for cancer research around the world. Talk about double standards! It's funny that an entire multi-billion dollar industry has been built around the pretense that the nude mouse is an adequate model of human cancers - BUT, when it comes to potentially implicating a vaccine ingredient in human cancers, well, now the nude mouse results are irrelevant.

If nude mice are not an adequate model for human cancers, why are they used to study human cancers around the world? You would think that after decades of pouring huge economic and scientific resources into studying human cancers in nude mice, we would have something to show for it, such as a cure for cancer. Which would seem to be an admission that, as stated, nude mice are not a proper model for, well, much of anything - other than how a MOUSE with NO EFFECTIVE IMMUNE RESPONSE will react to this or that. Not how a normal healthy human will react.

So why are they still used?

It's funny that when nude mice are used in cancer research, and when they are ignored when they implicate vaccine ingredients for potential human health dangers, in both cases Big Pharma makes hella bank.

Bryan,
Nude mice are used as models of human cancer to test cancer treatments, not to test what causes cancer in humans. They are particularly susceptible to cancer since they have a barely functioning immune system. The fact that nude mice develop cancer if injected with intact HeLa cells is not surprising, since that is what they were bred for, to allow implantation of human cancer cells without rejection. This does not mean that humans injected with HeLa cells will also develop cancer, even if vaccines contained intact HeLa cells, which they do not.

By Krebiozen (not verified) on 20 Jan 2015 #permalink