Bernard Dalbergue and Gardasil – another anti-vaccine shill says nothing

About 4 years ago, I wrote about a new anti-Gardasil name being foisted upon the internet. His name is Bernard Dalbergue, a French physician who may or may not have had some role with Gardasil development. Or manufacturing. Or sales.

Well, he had something to do with something with regards the HPV cancer-preventing vaccine. He’s another false authority pushed by the anti-Gardasil religion, a particularly nasty sect of the anti-vaccine religion. They bring out these individuals because the anti-vaccine troupe lacks the evidence to support their specious and deceptive claims about Gardasil.

So let’s dig in to this Bernard Dalbergue. Let’s see if there’s anything there. 

Source: CDC
Source: CDC

All about HPV and the cancer preventing vaccine

I know, I’ve written about this vaccine 100 times, so you’ve read these paragraphs enough to quote them without looking. Actually, I change it up with new information as necessary.

However, for some of you, this might be your first bit of research into the human papillomavirus (HPV) vaccine, so it’s important to get a brief overview of HPV and the vaccines. If you’ve read this before, just skip to the next section if you want.

Genital and oral  HPV are the most common sexually transmitted infections (STI) in the USA. There are more than 150 strains or subtypes of HPV that can infect humans, although only 40 of these strains are linked to a variety of cancers. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

Although the early symptoms of HPV infections aren’t serious, those infections are closely linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:

These are all dangerous and disfiguring cancers that can be mostly prevented by the HPV cancer vaccine. If you’re a male, and you think that these are mostly female cancers, penile cancer can lead to amputation of your penis. Just think about that guys.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco with respect to cancer. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. About 27,000 HPV-related cancers are diagnosed in the USA every year.

There were two HPV vaccines on the market before 2014. GSK, also known as GlaxoSmithKline manufactured Cervarix, a bivalent vaccine, but it has been withdrawn from the US market, because of the competition from the other HPV vaccines. In Europe and other markets, Gardasil is known as Silgard.

Merck manufactures the other HPV vaccines. Its first vaccine, the quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine. It targets the four HPV genotypes in the quadrivalent version, along with five additional ones that are linked to cervical and other types of cancer. Both versions of Gardasil are prophylactic, meant to be given before females or males become exposed to possible HPV infection through intimate contact.

Who is Bernard Dalbergue?

I guess the first question should be, “who is this Bernard Dalbergue and why does the anti-vaccine crowd trot him out as some sort of authority on the evils of Gardasil?”

This probably arises from claims that Dr. Dalbergue (yes, he’s an MD) is a “former pharmaceutical industry physician with Gardasil manufacturer Merck.” Yes, we’ve heard these kind of claims before about Diane Harper and Gardasil, but we’ll get to that in a moment. 

Dalbergue apparently made some nasty comments about Gardasil in the April 2014 issue (pdf, French) of the French anti-science magazine Principes de Santé (Health Principles). In that article, Dr. Dalbergue claimed that (translated from French):

The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless! Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.

Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it!

Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine.

I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.

There is far too much financial interest for these medicines to be withdrawn.

Let’s looks at some of these points. First, numerous large, case controlled studies have shown that the HPV vaccine is extraordinarily safe. Some of these studies have included millions (yes, millions) of patients. And what have they found?

The authors of one of these studies concluded that,

…this study identified no safety signals with respect to autoimmune, neurological, and venous thromboembolic events after the qHPV vaccine had been administered.

In another large study, of over 2 million patients in France (oh, the irony), the authors concluded that:

Our study provides reassuring results regarding the risk of AID (auto-immune disease) after HPV vaccination, but an apparently increased risk of GBS (Guillain-Barré syndrome) was detected.

This study further debunks Dalbuerge’s claims – but this study (but not all of these studies) have shown a slight increase for GBS. OK, time to talk about GBS.

Debunking Guillain-Barré myths

Some of the large Gardasil studies, but not all, have shown a tiny increase was Guillain–Barré syndrome (GBS), a rapid-onset muscle weakness caused by an autoimmune reaction that damages the peripheral nervous system. It is a serious autoimmune disease which can be debilitating with difficult recovery especially in adults over the age of 40.

Fortunately, GBS is extremely rare – the incidence is approximately 0.89 to 1.89 per 100,000 individuals. In the French study, the researchers may have shown a 1-2 per 100,000 individual increase in the risk of GBS in vaccinated groups. The absolute risk of GBS from Gardasil appears to be so small that it is hard to distinguish from background levels of GBS.

Moreover, there are several limitations to this study. First, they were unable to show whether H1N1 vaccine or an H1N1 infection, known risk factors for GBS, was a confounder.

Second, because of the extremely small numbers of GBS patients, it is possible that random chance causing the observation. You might need to do a study with 10 or 20 million individuals to actually distinguish the rate of GBS post vaccination versus the rate of GBS with no vaccination.

Finally, and most importantly, the researchers were unable to show any causality between GBS and HPV vaccination.

Although GBS is a serious autoimmune condition, it is difficult to place blame for it on vaccinations. In fact, most research points to infectious diseases which stimulate the autoimmune dysfunction. Further, a study of 1 million girls in Denmark and Sweden, along with a long-term clinical trial of the HPV vaccine, have provided no conclusive evidence that the HPV vaccine is linked to GBS.

Nevertheless, if future research shows that the HPV vaccine is indeed causal to GBS, the benefits of preventing cancer from HPV far outweighs the tiny increase in risk of GBS.

Bernard Dalbergue compared to Diane Harper

Dalbergue refers to Diane Harper as a “major opinion leader in the USA” with respect to Gardasil. And in case you don’t know about Dr. Diane Harper, she is a darling of the anti-Gardasil herd (I just linked one website, but there are dozens that repeat the same essential story about Dr. Harper).

The claim is that she decided to “come clean” about Gardasil so that she could “sleep at night.” The antivaccination world have attached themselves to this story, because they think it uncovers a conspiracy or lies by the vaccine manufacturers, and since Dr. Harper obviously escaped from the evil clutches of Big Pharma. The myth of Diane Harper also includes the ridiculous belief that she was the “lead researcher” for Gardasil.

Of course, there are lots of issues with Dr. Harper and Gardasil, with the main one being that she has a long history of publishing peer-reviewed studies that are very positive about HPV vaccines. Yes, you read that right, Harper’s publication history seems to contradict the memes of the anti-vaccine religion. I’m sure that someone will claim she was bought off by Big Pharma to toe the line. Or something.

But this story isn’t about Diane Harper, so let’s return to Dalbergue.

Bernard Dalbergue – his real story

Dr. Dalbergue’s story does seem awfully similar to Dr. Harper’s. Except for one small fact – I can find no evidence that he ever worked for Merck. None. At least Dr. Harper did actually work for Merck (though not in the role that is claimed by the anti-Gardasil gaggle).

As far as I was able to uncover through sources and background checks, Dr. Dalbergue was the Directeur Medicale (Medical Director) of a drug distributor, Martin & Harris Pvt. Ltd. Let’s look at this step by step.

Every medical products distributor in the world has a Medical Director, someone who signs off on documentation, occasionally holds pharmacy licenses, and provides advice on medical issues to the partners, principles and executives of the company.

In a real pharmaceutical manufacturing corporation, the Medical Director has a critical role in their research and development. Almost every medical products or pharmaceutical company must have a medical director (who is almost always an MD) to approve regulatory documents.

However, being a Medical Director for a minor pharmaceutical distributor, by itself, lends no credence to a statement that he was deeply involved with Merck. Bernard Dalbergue was not employed by Merck.

Since Martin & Harris was not a primary manufacturer of vaccines, Dr. Dalbergue had little, if any, access to privileged information from Merck or any other pharmaceutical company. As best as I can determine, Martin & Harris is a defunct distributor of pharmaceuticals

Just a brief aside in this discussion. Pharmaceutical companies, in general, do not sell directly to hospitals, physicians or pharmacies. Owning and maintaining a huge international distribution network for just a few drugs would be incredibly inefficient and expensive. So, a whole industry of medical products distributors has grown up throughout the world, with the USA having a rather complex system of distribution with separate distributors focusing their efforts on either the hospital, physician or retail pharmacy markets (and generally, there is no overlap).

Basically, the distributor gets about 15-30% of the price paid by the hospital for a product. So, if a $40 vaccine is purchased by a physician, the distributor gets around 20% or $8, and the pharmaceutical company around $32. But I’m oversimplifying this system because it would require a 50,000 word article to adequately describe the medical distribution system. No one would read that.

The point is that distributors are not owned by the manufactures (actually that’s illegal in the USA), and Big Pharma treats distributors with disdain, sometimes unbridled disgust. Essentially, Big Pharma considers distributors nothing more than truck drivers who take profits away, when in fact, distributors are generally the people who have relationships with the hospitals and physicians. It is a world of love-hate relationships that would surprise most people.

I’m willing to accept the fact that Dr. Dalbergue was a Medical Director for a possibly defunct distributor, because that appears to be public knowledge. But he’s going to have no inside knowledge of what Merck was doing with Gardasil. None at all.

The distributor’s truck drivers are going to know as much about Gardasil, which is close to nothing. The information and research at Merck is so highly protected by confidentiality agreements, they wouldn’t pass along data to Dalbergue because he could take that information to GSK, for example. Dr. Dalbergue wouldn’t have any inside knowledge of Merck’s activities, no more or less than I do (though I probably have a LOT more, because of my former life).

A few French speakers have read some of the French language articles about Dr. Bernard Dalbergue which has been helpful in understanding better his relationship with Merck. The company did indeed acquire Martin & Harris, and terminated all of the executives of the company (something that is typically done, and don’t worry, in these cases, the executives receive substantial payouts so they’re not begging on the street), including Dr. Dalbergue. I guess this attempt to denigrate Gardasil is his revenge, because he certainly would have no insider knowledge of the vaccine, during his very short employment with Merck.

But let’s be clear, unless someone publishes documents disputing what I have written here, I strongly doubt that Dr. Dalbergue had any formal or even informal relationship with Merck. This is simply an invention of a wild imagination, furthered by his own public comments. It’s annoying at best.

In fact, comparing Dalbergue to Dr. Harper is an insult to her. She actually does research. She actually has a substantial publication record with HPV vaccines. She is currently employed as a researcher in the University of Louisville School of Medicine. And remember, Harper appears to be a supporter of the benefits of the HPV vaccine.

On the other hand, Bernard Dalbergue has nothing. He really wasn’t a Merck researcher. He has no inside information about Gardasil. But he does qualify as a false authority, something the anti-vaccine horde loves.

And in summary

Dr. Bernard Dalbergue is not an authority or insider to Merck or any other Big Pharma corporation. He has no inside knowledge of clinical trials, post marketing studies, or adverse events with regards to Gardasil or any other HPV cancer preventing vaccine.

But that doesn’t stop the anti-vaccine religion from using him as their false appeal to authority – a so-called expert who really isn’t an expert. The anti-vaccine side seems to love these types, like Tetyana Obukhanych, who might have some credentials, but no published scientific evidence that would support their claims.

It’s kind of amusing. We, the pro-vaccine forces who want to protect our children, have distinguished scholars like Paul Offit, whose rotavirus vaccine will save over several hundred thousand lives a year. And anti-vaccine crowd have individuals like Dalbergue who hasn’t done much of anything.

Citations

 
 
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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor

Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!