Posted on 12/18/2007 6:51:54 AM PST by jalisco555
LONDON — Shares in GlaxoSmithKline PLC dipped Monday after Europe's largest drugmaker said that the U.S. Food & Drug Administration has requested more information on its cervical cancer vaccine Cervarix before it grants marketing approval.
The company had said earlier that it expected to start selling the drug in the United States in 2008. It is expected to become a multibillion-dollar product.
The company received a so-called complete response letter, which the U.S. regulator issues when the review of a marketing application file is completed and questions remain to be answered prior to approval.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, GlaxoSmithKline's vice president and director of North American vaccine development.
GlaxoSmithKline shares fell 2.2 percent to 1,294 pence ($26.12) on Monday in London.
To be specific, these vaccines should prevent 70% of cervical cancers.
If GSK is getting involved they smell money at the risk of destroying human life. And if GSK is involved in a specific drug I would stay away from it at all costs.
It does nothing for cancer. It MAY prevent a virus that MAY cause cancer..
1. Q: What is HPV?
A: HPV is a common virus. In 2005 the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV. Some cause no harm; others can cause diseases of the genital area. For most people, the virus goes away on its own. When the virus does not go away, it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type.
As for genital warts, they are caused by another group of HPV types. These don't cause cancer. 90% of genital warts are caused by HPV types 6 and 11. These infections are prevented by Gardasil but not Cervarix.
American Cancer Society - Do We Know What Causes Cervical Cancer?
But HPV does not completely explain what causes cervical cancer. Most women with HPV donÂ’t get cervical cancer, and certain other risk factors influence which women exposed to HPV are more likely to develop cervical cancer.
Oncology Channel - Cervical Cancer
The cause of cervical cancer is unknown. Infection with two types of human papillomavirus (HPV), which is transmitted sexually, is strongly associated with cervical and vulvar cancer and is the primary risk factor. Evidence of HPV is found in nearly 80% of cervical carcinomas.
The 80% figure is inacurrate. The seminal paper on the topic is by Walboomers et. al.
The title “Human papillomavirus is a necessary cause of invasive cervical cancer worldwide.” says it all. Numerous subsequent studies have confirmed this conclusion. (Sorry, I’m HTML challenged so I don’t know how to reformat the citation).
Your other point is valid. Most women with HPV don’t get cancer. The reasons for this aren’t fully known. HPV is a necessary but not sufficient explanation for why women get cervical cancer. Clearly there are co-factors, possibly environmental, possibly genetic. For example, it’s well accepted that women who smoke cigarettes have a risk of cervical cancer 2.5 or 3 times that of non-smokers.
About the article. There was a thread a year ago about Gardasil. There was info posted about GSK on it. As I understand it, GSK is using a different "base" for their vaccine and did 1 more years testing before requesting FDA clearance. I read that Merck used the base as the placebo in theit tests and it caused as many problems as the vaccine. That brings down the number of incident reactions and, I believe, skews the findings.
You said in post 6, These infections are prevented by Gardasil but not Cervarix.
So just what is Gardasil? They call it a (incorrectly) a cancer vaccine but it also prevents genital warts virus. So is THAT what this is about? The explosion of genital warts that has nothing to do with cancer? Are they just using the cancer scare to get people to use Gardasil? That's my guess. Cervarix is aimed only at the virus that may cause cancer. And that's NOT the aim here as it's rare in the US. Scare parents into getting Gardasil as a cancer prevention when the aim is preventing genital warts. What parent would get their daughter a vaccination for genital warts? None.
http://content.nejm.org/cgi/content/abstract/348/6/518
HPV prevelance was 96.6% using the most sensitive method. Granted, it's worldwide as well but there's really no difference between American cervical cancer and non-American cervical cancer. It's the same disease.
There's no way the hospital tried to vaccinate a newborn against HPV. The FDA approval of Gardasil is for females ages 9-26 only, not newborns.
As for genital warts, these are caused by different strains of HPV than cause cancer. There are over 85 different types of HPV identified so far. Of those around 20 infect the female genital tract. The types that cause genital warts don't cause cancer. But, genital warts result in over 300,000 doctors office visits annually and are an enormous cause of distress among women. Preventing this is certainly desirable.
Nice to know that my kids and I are liars. Done. Bye.
Oops, my apologies. Didn’t mean to call you a liar. What I should have said was that I’m sure there was a misunderstanding, since the vaccine is only approved for the 9-26 age group. It just isn’t given to newborns any place I’m familiar with.
And you didn't actually address the rest of my post. If this is all about cancer, why the concern that ceravix doesn't prevent genital warts? I thought cancer was their bogeyman?
There's also the problem of the base used in Gardasil. By itself it causes adverse reactions. GSK chose a different base to use. I think Merck rushed out with their product and the FDA is protecting them. GSK chose to hold theirs back another year for more testing.
I'm sorry but I'm not on my machine so I have no links. My machine is, um, "resting". I'm on an alternate computer that sits on a dresser. Ya gotta be a committed Freeper to sit on a tub and lean WAAAAAAY forward to post. LOL My knees are screaming so I'm going to have to call it quits soon.
Preventing cancer is by far the most important thing. Preventing genital warts is an added advantage that Gardasil has over Cervarix. However, on the flip side there is evidence that Cervarix may protect against more than just the top two virus types, although this evidence is preliminary.
I'm not an expert on vaccine bases so I can't really comment on that. Just to say that in the clinical trials of Gardasil the adverse reaction rate in both the study and control groups was the same and no serious reactions were reported.
Yeah, I gotta go back to work as well. Which, believe it or not, is to prepare a medical school lecture on HPV!
Maybe we can chat again sometime. My problem with Gardasil is they aren’t quite honest in testing methods etc. A placebo shouldn’t be the same as the adjuvant as that skews the outcome. I have more concerns but maybe we can chat again sometime.
Sure, that would be fine. This subject isn’t going away, that’s for sure.
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