The big Pharma company, a vaccine and your kid

[greg334]

I listened to a lot debate and criticism this morning on the way to and from the vet about the Texas Governor who has made it mandatory for all 6th graders to be vaccinated for HPV with a vaccine that is made by Merck, the Vioxx people.

Now working at a big Pharma company (larger than Merck) and knowing how Phase 2 and 3 studies are supposed to work, I am weighing in on the side of not to do this to your kid.

This is a vaccine that should have had a 100% disclosure of all data to the FDA, which is not done with any drug. This drug was raced through the FDA fast track system, which is a mess to the point that there are a lot of mistakes made in this system and lobbied heavily to make sure that the maximum patent time is leveraged for maximum profits.

I don’t trust the company that has been damaged through lawsuits, like the multiple Vioxx lawsuits and having the drug removed off the market. There is this mentality that they must make up the loss. They may have good drugs in their portfolio but truthfully, COX2 inhibitors (Vioxx and other drugs based on this formula) effectiveness in any form compared to the safe use of the drug has been questionable right from the Phase 2 studies.

I don’t like the marketing of the drug itself, the commercials, the lobbying and the buying of politicians. In the case of Texas, there is something else going on here and I think that there should be a serious investigation to see if the governor didn’t break any laws.

These reasons and more are a concern for me even though I don’t have kids. I simply mean we don’t know what the impact of the drug in the long term in comparison to the disease it is used to prevent. We also don’t know what if any affects the drug actually has against stopping the disease because we are fighting a virus which means that viruses by design are made to change to survive.

 

[blueeyes]

Hey Greg,
This is t-hawks wife. He thought I'd be interested in your post. He's right! What did you do with your 'big pharma' job?

Although I agree that the Texas Governor has no business making this decision and I have no idea what his motives are, I strongly support Gardasil (the HPV vaccine). I disagree that this has anything to do with the Vioxx situation.

Vaccines are a hotly debated subject, but have excellent track records and provide us protection from many viruses. Talk to someone old enough to remember the days before vaccines. These stories are not restricted to the past. Every day, around the world, they are lived again and again by people not blessed with the availability of vaccines.

You mentioned that "This is a vaccine that should have had a 100% disclosure of all data to the FDA, which is not done with any drug." I can't attest to the validity of that statement, but if it's true I wonder why you feel this way. Why would you feel that this vaccine be treated any differently than other drugs?

I also don't know if the drug was put through the FDA fast track system. How long does it take for the fast track?

What I do know is that (IMO) this was a well run and well organized study (I'm a research coordinator and coordinated one of the trials-of which there were many and continue to be many-done on this vaccine) and it showed 100% efficacy in preventing the viruses it is designed for. 100%!! Two of the viruses are the most common cause of genital warts and two of the viruses are the most common cause of high risk changes to the cervix which can lead to cervical cancer. It doesn't protect against all types of HPV and doesn't pretend to, but it's a huge start. HPV is the most widespread STI (sexually transmitted infection) with an estimate that at least 90% of us have had it at some point in our lives.

I've heard other people complain about the advertising for Gardasil. I personally think it has been good, although in general I don't like the advertising being done by the pharmaceutical companies.

 

[Fr8 Shaker]

This is also an infection which does not affect men but can and will be transmitted by men. Men will show no symptoms of having this infection but will be a carrier of it. And there is no test which can be done on men to see if they have HPV. The only way a woman will know if she has it is to have a pap test done. So if you haven't been with your partner for very long or if you are with or planning on being with a new partner use protection. (ALWAYS).

This has been a public service announcement !

 

[bambam]

i think it should be the parents choice to get the vaccine
i have had hpv for 12 years and they can not get rid of it with me but i have pap smears and no cervial cancer but they have taken samples and sent them to Moffit cancer inst to expermint and see why i have not developed cancer
i pray i will never develope cancer
god bless and keep rolling

 

[kinilu57]

Does this mean that once a man has HPV, he will spread it the rest of his life including back to the woman that has had the cancer removed through surgery? I personally know 2 woman right now that recently got diagnosed with this. After she is cleared, then what???

Cindy and Brian
FECC D6084 :'( x(

 

[Fr8 Shaker]

As far as I know the answer is yes, the man will always have it as there is no treatment for it yet. The sad fact is there is a high percentage of men that have the HPV infection but don't know they have it because it does not affect men and has no symptoms. I would say that your friend has a very good chance of being re-infected if she doesn't use protection. She should talk with her doctor and see what he/she says.

 

[blueeyes]

The info here isn't exactly accurate, so I would encourage anyone with questions about HPV to look at www.ashastd.org for better information. Or follow this link:
http://www.ashastd.org/hpv/hpv_overview.cfm

HPV is not completely understood. Many people get it and then their body gets rid of it, much like other viruses such as the common cold. Other people tend to hang on to the virus. They do know that smoking and poor diet seem to contributing factors to not getting rid of the HPV. You can also have HPV for many, many years before showing any signs or symptoms. This has been known to stress a few marriages!!

And it's not true that men aren't affected. Certain strains of HPV cause genital warts and men are definitely affected by that. It can also cause penile cancer. Not sure of other implications.

Anyways, check out the site!