Why Should We Believe Merck?

Net1.Net

June 6, 2009

I read this absolutely horrific story yesterday about young girls suffering from crippling and baffling conditions shortly after they were vaccinated with Gardasil. The article is balanced by an interview with Dr. Paul Offit, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia:

According to foremost vaccine expert Dr. Paul Offit, the reason no one has found a link between Gardasil and severe adverse reactions is because there’s simply no link to be found.

Offit believes that when it comes to medical issues and particularly vaccines, the media is a kangaroo court that sensationalizes individual stories full of erroneous and unfounded claims, which dangerously rigs the public to mistrust perfectly safe vaccines.

“Frankly, it’s hard to watch,” says Offit, chief of infectious diseases and director of the Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP).

“You’ll have the child or the parent of the child or adolescent girl saying, ‘I was fine, I got the vaccine, now I have permanent paralysis, or now I have a blood clot or stroke or heart attack,” he says.

Offit claims that the serious side effects reported by patients after receiving Gardasil shots are not happening in any percentage higher than is to be expected in the baseline population. “[The HPV vaccine] is only designed to prevent HPV. It’s not designed to protect everything that happens in adolescence and young adulthood,” he says.

The problem is, as Offit recently told Philadelphia magazine, you can only prove a hypothetical connection more and more statistically unlikely—but you can never prove never. He offers, for example, that if he runs around his backyard trying to fly and never takes off the ground, it doesn’t prove he can’t—just the more times he tries, the more statistics will show its improbability.

But critics often question the real motive behind Offit’s vaccine recommendations since he’s made millions of dollars off a vaccine (RotaTeq) he co-invented; its patent was sold by CHOP to Merck. Anti-vaccine activists have called him a monster, an industry shill for Big Pharma, a “terrorist” bent on poisoning children for blood money.

“Certainly, the government and pharmaceutical companies have acted at times badly,” he admits, but says that’s not the issue when considering taking medicine, especially a vaccine like Gardasil. “The question is what stands that serves you and your child.”

Offit believes science stands to serve the public good, and in this case, science has offered the “brilliant” design of the Gardasil vaccine: a clone of a single protein cell of four strands of the HPV virus that, when plunged into a girl’s arm muscle, then protects her from HPV strains 6 and 11, responsible for most cases of genital warts, and strains 16 and 18, responsible for 70 percent of cervical cancer cases.

Offit says the Internet can be a dangerous place. “It enables people who have unusual and incorrect ideas to very quickly find other people like them to believe the same thing and it amplifies their paranoia, their false belief.” Offit has given his 14-year-old daughter the shots.

Still, even the most vocal pro-vaccine scientist in the world admits that “the choice not to get a vaccine isn’t a risk-free choice, it’s just taking a different risk.”

Now, I’m not gonna call this doctor anything, except maybe criminally naive. (And that’s kind.) As someone who once worked with FDA compliance matters, all I’d say is, go read the FDA website and tell me why we should take any drug manufacturer’s word on clinical trials, or trust anything from the makers of this vaccine.

I mean, why should the burden of proof be on us?

Because Gardasil is made by Merck. Remember Merck? That’s right, the same pharmaceutical company which just paid to publish a series of fake medical journals to sell their products. It presented itself as if it were a peer-reviewed journalbut it actually had completely unverified data supplied by the manufacturer.

And here’s a warning letter that was sent by the FDA in April 2008 to Merck at the very location where they manufacture Gardisil (do I have to point out to you how bad it must be to be cited by the Bush administration?):

The Food and Drug Administration (FDA) conducted an inspection of Merck and Company, Inc., West Point, Pennsylvania, between November 26, 2007, and January 17, 2008. During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice (CGMP) in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components. These products include Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®. These deviations from CGMP include non-compliance with Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the requirements of your biologics license application approved under Section 351 of the Public Health Service Act (PHS Act), and Title 21, Code of Federal Regulations (21 CFR) Parts 210 and 211.

[…] You failed to exercise appropriate controls over computer or related systems to assure that changes in master production are instituted and input and output from the computer or related system of formulas are checked for accuracy and maintained [21 CFR 211.68(b)], in that there is no documentation to support software manufacturing change performed to the [redacted] used in the manufacture of Gardasil®, lots [redacted] and [redacted].

I asked an industry source what they thought. The response:

There has been a huge push for the expansion of vaccine development as a public health matter. The private sector, in the rush to meet the need, may not have been as careful as it should have been in expanding production.

The potential for the events that lead to the issuance of this letter having serious consequences to patients receiving the vaccines is significant, in that the safety and efficacy of the vaccines manufactured under these conditions is in doubt.

So what does that mean in plain English?

There could also be insufficient amounts of the proper ingredients, or a defect in the raw materials used to make the vaccines, or that the ingredients could have deteriorated over time as a result of the presence of contaminates, or of the vaccine doses not being sealed properly, or of a deviation in the manufacturing process.

Bottom line for me? As long as the manufacturer is using falsified data to sell their products, and is not even meeting the FDA manufacturing standards – well, I wouldn’t allow my kid to get this vaccine.

UPDATE:Darthmouth’s Dr. Diane Harper, who’s one of the top experts on HPV and who worked on the original clinical trials for Gardasil, is on record as opposing mandatory use of the vaccine. She says it wasn’t adequately tested on younger girls, and I found this quote fascinating:

But Dartmouth Medical School’s Diane Harper says that the vaccine could cause problems when young girls are getting other inoculations at the same time.

She says the immune system can become confused by more than one vaccine.

“We don’t know yet that the immune system will look at both and say ‘oh yes a good army of antigens’ or it might say ‘one is here and I can’t see other one’ and not make antibodies to it or it may say ‘gosh we’re seeing all these foreign invaders’ and attack the body itself.”

It sure sounds like that’s what’s happening.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.