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Maker of HPV Vaccine Under Fire

Regulators found problems at US plant where Gardasil is made for BC.

By Andrew MacLeod, 16 May 2008, TheTyee.ca

Merck Building

Manufacturer Merck scrutinized.

While British Columbia Health Minister George Abbott was announcing the province will provide a controversial new vaccine starting in September with assurances that it is "safe," the American Food and Drug Administration was threatening to close the factory where it is made.

The B.C. Centre for Disease Control's director of immunization programs, Monika Naus, said she had seen the media reports on the problems at Merck's plant in West Point, Pennsylvania. She believed the same plant supplies vaccines to Canada, she said, but it was unclear whether any of the lots coming here were affected. "I basically know what you know. The company's taking it very seriously."

The province gets several common vaccines from Merck, she said, including ones used for mumps, hepatitis A and hepatitis B. Merck will start supplying Gardasil, used to prevent strains of the human papilloma virus (HPV) that are associated with cervical cancer, to B.C. in August.

A Merck Frosst Canada Ltd. spokesperson in Montreal, Sheila Murphy, confirmed the company makes vaccines for export to Canada at the same Pennsylvania plant the FDA is investigating. Merck will do what it needs to do to meet the FDA's requirements, she said. "We're taking care of it."

In Canada, monitoring of vaccines or other treatments is done by the federal government. A Health Canada spokesperson said in an e-mailed response to questions, "Health Canada is monitoring the situation and reviewing Merck Frosst's response to the FDA . . . . This will inform the assessment that is underway regarding the impacts this warning letter has (if any) on the safety of vaccines available in Canada."

Warning letter

The FDA's 3,500-word, April 28, 2008, letter, addressed to Merck president and CEO Richard Clark, said the warning was the result of inspections conducted at the plant between Nov. 26, 2007 and Jan. 17, 2008.

"The FDA investigators documented significant deviations from current good manufacturing practice . . . in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components," the letter said.

For example, there were shipments of MMR vaccine that failed visual inspections for "critical defects" that were distributed anyway, even though the problems had not been thoroughly investigated. Nor were staff investigating and documenting problems as well as they should, the letter said.

"The deficiencies described in this letter are indicative of your quality control unit's inability to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug product and drug substance."

The letter said Merck responded on Feb. 15, but the FDA said "we believe your response(s) did not provide sufficient detail to fully assess the adequacy of the corrective actions." It concluded, "Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions may include license suspension and/or revocation, seizure or injunction."

Canadian vaccines imported

Merck's Murphy said the only thing unusual about the letter is that it became public. "From our perspective, Merck and the FDA work very closely together," she said. "It's the kind of communication that happens all the time."

It is normal business that the regulator asks questions and the company responds, she said. These sorts of letters are sent frequently, she added. "What makes it out of the ordinary is someone got their hands on the communication."

Asked what guarantees Canadians have that imported vaccines are safe, she said, "I think if you're looking for other assurances, don't forget I work for the company, you're going to have to call Health Canada. They're the agency that controls our business here in Canada."

About 70 per cent of vaccines are imported, according to the e-mail from Health Canada's spokesperson. Health Canada officials will often visit manufacturing plants before allowing a new vaccine on the market. Once a vaccine is approved, samples of each lot are sent to Health Canada, along with the company's own test results. The agency may then do its own "targeted" testing on the lot.

Health Canada also pays attention to reports of adverse reactions, he said, and works closely with other regulators such as the FDA. When there are concerns, he said, officials may visit the plant in question.

Other vaccines recalled

B.C. will start providing Merck's Gardasil to young women in Grades 6 and 9 in September. They will be given three shots over six months as part of the $39 million, federally-funded program. After three years, the province will start providing the vaccine only to girls in Grade 6.

Taking the vaccine will be voluntary, though provincial health officer Perry Kendall said he hopes 90 per cent of those eligible will get the shots.

There have been other concerns raised about Merck vaccines in recent months. In December, the FDA recalled 13 lots of vaccines for hepatitis B, pneumonia and meningitis. News reports said at the time the company was having problems with sterility at its West Point, Pennsylvania plant.

Also in December, Health Canada warned people not to use three lots -- some 200,000 doses -- of Merck's vaccine for measles, mumps and rubella after five Albertans had allergic reactions to the vaccine. All had a previous history of allergies and recovered.

At the time, Merck's Murphy told Reuters news service the company was looking into whether there had been other cases of anaphylaxis related to the vaccine elsewhere in the world and "from the manufacturing side whether there has been any anomaly in the production of the vaccine."

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17  Comments:

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  • ME2

    3 years ago

    High Finance

    In discussing the previous article, HPV Vaccine for Girls Oversold? with a German pen-pal, the following exchange took place re the cost of the vaccine :

    Noting her mentioning that in Germany the three shots cost 500 Euros, and remembering the article stating "After that the province will fund the campaign itself, he said. It costs over $400 for the three shots necessary to protect a person against the virus.", prompted me to ask her :

    Do you have a site which quotes 500 Euros? Can you give me a quote? She responded, "Die drei Impfdosen kosten in Deutschland derzeit 465 Euro, in den USA 280 Euro und in Österreich 624 Euro." (The three vaccinations cost 465 Euros in Gemany, 280 Euros in the US and 624 Euros in Austria.)

    If you can read German, this is the site.

    http://www.freitag.de/2007/17/07171801.php

    So,in the US the price is - in US Dollars, $433; In Germany,$720; In Austria $966. (1 Euro = 1.55 US Dollar).

    Interesting, I hadn't realised freight rates were that high :-)

  • James Burns

    3 years ago

    Gouging

    Quote:
    So,in the US the price is - in US Dollars, $433; In Germany,$720; In Austria $966. (1 Euro = 1.55 US Dollar).

    This is exactly why I have such a huge problem with for-profit companies involved in the production of vaccines. Those figures are truly disgusting.

    But the apparent negligence on the part of Merck in the production of vaccines is a far, FAR more serious problem. It puts the safety of the public in considerable jeopardy. In addition, if contaminated vaccines are sold and do harm, it will cause public alarm over vaccine safety in general, which will result in less use of an exceptionally effective public health measure. The alleged negligence on Merck's part, if accurate, is very serious, and they should be punished for it.

  • City Person

    3 years ago

    Plus de change

    Similar hysterics were common when the Salk vaccine was introduced, as was when fluoride was added to water.

  • James Burns

    3 years ago

    Helloooooo

    CP there is a big difference between unfounded scaremongering, and being cited by government inspectors for poor and possibly dangerous quality control. Failing a visual inspection for critical defects is serious. Selling possibly tainted products, particularly something like a vaccine that is injected into people's bodies, should be a potentially criminal issue. Concern over this isn't even remotely hysterical.

  • Frank

    3 years ago

    CP

    Quote:
    Similar hysterics were common when the Salk vaccine was introduced, as was when fluoride was added to water.

    Was this before colour tv? Can I call you geezer from now on? Just remember CP, Purity Of Essence, never waste a bodily fluid. I think that's what all you militant anti-commies used to tell each other right?

  • G West

    3 years ago

    Salk

    There actually were some difficulties with the original Salk vaccine - which was why they moved to another one, the Salk/Sabin vaccine a few years after Salk's discovery in 1953.

    As for hysterics and scare mongering, c'mon, the Polio vaccine was universally welcomed and has, for the most part, lived up to its original promise.

    The controversy and the hysterics with the vaccine, occurred more than a generation later, in the 1980s. A little knowledge is often misplaced – sadly, on line ‘knowledge’ is often mis-used.

    I welcome respectful comments to my posts here at Tyee.

    G West

  • Canis Latrans

    3 years ago

    The free market...

    Quote:
    Interesting, I hadn't realised freight rates were that high :-)

    The actual cost of production is, of course, in the so-called "free market, but a secondary consideration in determining the price of a commodity. The primary determinant is again, of course, what the market will bear.

    As for cp. He is of little use or contribution here, other than as comic relief-, and not worth a thin dime at that. :-)

  • ME2

    3 years ago

    Canis L.

    One can only assume then, that our so-called business-oriented politicians are not at all as astute in deal-making as they'd have us believe.

    The only other assumption one could make is that other, behind-the-scenes "deals" have been made.

    Given the hundreds of other areas where tens of mllions could make a real difference and yield proven payback, one has to wonder what prompted them to spend so much money on something with such doubtful efficacy

    There's CPs on every site, and they only go away when they are ignored.

  • Canis Latrans

    3 years ago

    Yup...

    Quote:
    The only other assumption one could make is that other, behind-the-scenes "deals" have been made.

    Yup.

    Quote:
    There's CPs on every site, and they only go away when they are ignored.

    And yup. Been dealing with these mofus all my life. :-)

    Busy day. Catch ya's later. Got on my hoss's back yesterday without getting bucked off. That's twice in a row now. Which is my definition of progress. :-) lol. ( A guy can't get thrown like that too many times, when he's looking down both barrels of being 70.)

  • margot

    3 years ago

    HPV in 1967

    There is no cure that I've heard of, though I was cured several times. Big ugly white warts, the size of quarters, and all other medical belief systems are just voodoo?

    Maybe, to preserve a woman's ability to bear children, since western medicine can't seem to do a thing about HPV except pretend to vaccinate against it, we should routinely cut young women's labia off, when they are about nine. The way they do it in those "primitive" African and Arab countries.

    We get the broken glass applied by grannies stories, I got the best of western medicine at the time. I now really question, far too late, whether I could have had children.

  • margot

    3 years ago

    HPV and the triumphs of western med

    I was infected with HPV in the late spring of 1967 in Portugal. My lover flew to Canada, and during the taxi ride home, one of his best friends told me I might be infected with something. He was short on details.

    I went straight to a VD clinic, got examined and sampled and given a clean bill of health. But the best friend had seemed so earnest and sure. I visited some medical students, and one of them told me she thought there was something new out there, a genital condition that might be connected with something like gum disease.

    About six months and hundreds of miles later, I got a loose tooth and had it extracted. I was given a piece of paper that entitled me to a shot in the bum.

    Several letters to and from home later, I learned that the antibiotic I'd reacted very strangely to had been banned in N. America for decades.

    About a year later, the warts appeared, huge and flat and white and really itchy. They were so terrible, they were funny, even at the time.

    The clever French doctor I went to told me to insert yeast infection losenges on a little stick every day for two weeks or so. When the warts disappeared, I figured, for the second time, I'd been "cured". I'd made high marks in Shakespeare courses, but I didn't realize how Elizabethan this was.

    Late in '68, I was in a NYC free clinic being fitted with a contraceptive device (removed in '70 by a BC gynaecologist, who waved it around saying "where the hell did you get this, the ark?"). The young NYC doctor answered my question about my mysteriously (cured?) warts with blithe amusement. Nothing to worry about anyway, "Jacquie Kennedy has them".

    My "celebrity" warts seemed to be in remission for many years. They showed up as an itch (swab daily with hexacholorophene! mid 70s), and a tiny swarm (burned off with silver nitrate in '76) and then in full potentially cancerous glory in the summer of '76.

    $$$$$ Shazamm. The original the ark? hexachlorophene gynaecologist, who lost my file and went duck hunting in Louisiana, got the gig of cutting off my labia (truly dazzling great job, cosmetic surgery nowadays and of course, when done badly, genital mutilation). And then, my uterus.

    I wondered, very soon after, if there were videos of me in all my glory of those days, to lure extremely wealthy patriarchs to have their daughters done in BC.

    HPV in my experience showed up the worst of western medicine, while rather ridiculously providing me with gorgeous(?) and sought after streamlining.

    It took ten years for any kind of cervical signs to show up, so current claims that PAP tests find it, particularly in young women, are absurd. This is important, as there is evidence that vaccinating people who already are infected is a really really bad idea. Thus the ages of the targets.

    I recently sat next to a nurse who works in a northern native community in Ontario who was sure that PAP tests identified HPV.

    I had PAP tests every year.

  • ME2

    3 years ago

    James Burns

    My German correspondent added to her previous comments with this :

    "Today I have read in a scientific magazine that even some girls became ill and died after the vaccination. They wrote that condomes and medical checkups would be enough in order to prevent cervical cancer"

    I asked her for the site, and she responded with this :

    "I have found an article in English about the same issue. I think my daughters will not get that vaccination....."
    http://www.lifesitenews.com/ldn/2007/sep/07092004.html

    I don't know how trustable that site is, but perhaps with your expertise you can verify the information.

  • margot

    3 years ago

    condoms and checkups

    James, and all, please read my post, there is no test for HPV that means anything about young people. It takes a decade to show up on a PAP test.

    Also, in my personal opinion and experience, condoms do not protect anyone from HPV as it seems it can be spread by warm genital contact, say lying together, rather than actual sexual activity. It's about warts.

  • margot

    3 years ago

    ads

    check out the hpv pictures ads upper left.

    Western med is so so Elizabethan...

  • ME2

    3 years ago

    Margot

    I was not trying to upstage you. Our posts appeared simultanously.

  • James Burns

    3 years ago

    Lifesitenews

    Quote:
    The service was originally started by Campaign Life Coalition (CLC), a Canadian national pro-life organization headquartered in Toronto, Canada. Campaign Life Coalition, founded in 1978, was one of the first pro-life organizations to emphasize the international dimension of attacks on life and family. Along with a few other groups it pioneered pro-life lobbying at United Nations conferences. CLC president, Jim Hughes, is currently also vice-president of the International Right to Life Federation.

    Pro-life groups are typically religiously affiliated. Those groups disapprove of premarital sex, and anything they think might encourage it, like condoms, the pill, HPV vaccine and the like. In addition, they are predisposed to an anti-science point of view for obvious creationist reasons.

    If you note the presentation of the article about the HPV vaccine on the LifeSiteNews site, you'll see that they mention death and thousands of adverse reactions in the same headline. The clear intent here is to have people confuse the number of adverse reactions with deaths. Moreover, they provide no details of the deaths they do claim are "associated" with the vaccine. Did the individuals die immediately after being vaccinated? Or did they die some period after, for totally unrelated reasons? The same holds true for lost pregnancies (although I find it surprising pregnant women would seek to be vaccinated for HPV). Frankly, I wouldn't trust anything from that website given the clearly biased way they present information.

    Now, if there are peer reviewed studies available showing an unusual incidence of adverse reactions to HPV vaccine, then I'd say it certainly warrants further investigation. BUT chances are, adverse reactions are far more likely due to quality control problems in the production of the vaccines. There is a lot in a vaccine besides the inert virus, and those chemicals are usually what people react allergically to if they do have that kind of reaction. In addition, if Merck is being sited for quality control problems then the vaccines could be tainted in a manner similar to how food packaged in unhygienic conditions can be tainted.

  • James Burns

    3 years ago

    margot

    The HPV vaccine isn't exactly a cure, as it doesn't protect against all strains, but it would certainly reduce the likelihood of infection.

    Western medicine is a practice staffed by fallible humans. The professionals that populate it are of varying quality. In addition, physicians here tend to under emphasize prevention (like vaccines, good eating habits, etc.). They make their money by billing the system per visit and per procedure. They have no real incentive, beyond care for patients, to encourage prevention. In fact, the whole system encourages them to spend as little time with patients as possible to maximize their income. So it's little wonder that something like HPV didn't register with the physicians you saw. And given the belief at the time that genital warts were really only a nuisance disease, they likely didn't consider it to be a big deal. I know that doesn't speak well of the profession.

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