Wednesday, January 14, 2009

FDA Weighs Gardasil for Boys and Men

Share
Note: If you are interested in Gardasil for boys and men, please see more recent posts:
here (9/9/09) and here (9/10/09)

FDA Weighs Gardasil for Boys and Men

In late December pharmaceutical giant Merck filed for FDA approval to market its controversial Gardasil vaccine to boys and men.

The move was not unexpected, given that a Merck study of 4,000 boys ages 16 to 26 showed Gardasil to be effective in preventing 90 percent of cases of penile cancer and genital warts, caused by the same four strains of HPV that currently cause 70 percent of cases of cervical cancer.

The FDA will take up to two months to decide whether Merck’s application meets its standards; it could then take ten months or more to review the data.

Although Merck might have a tough job persuading heterosexual males to undergo the expensive and painful series of shots, homosexual men are expected to be a big market as Gardasil may well be an effective weapon against anal cancer.

Presumably men will experience the same side effects of the shots as women. Gardasil has been associated with Guillain-Barré Syndrome, pancreatitis, seizures, paralysis and blood clots in the heart, lungs, and legs, among other issues: the majority of side effects reported to VAERS thus far, however, are pain at the injection site and fainting.

Gardasil is currently being marketed to girls as young as nine. The CDC recommends that it be routinely given to 11 and 12 year-olds or before sexual activity begins.

Merck’s stock is still down after the FDA denied its application for Gardasil to be marketed to older women, citing the need for further data and completion of a 48-month study. MRK is trading at less than half of its one year high.

What do you think? Would you get Gardasil’s 3-shot vaccine for your sons? Or have you yourself, or your daughter, experienced any side effects from the shot?

31 comments:

ShelbyG said...

If all the women are getting it then that should fix the problem at the lowest level, but what if a man wants to get it down to avoid getting HPV down the road. Why not let the men choose? Obviously it has to be approved, but the FDA isn't approving whether it will be given to all young men and boys, they are determining if it is safe for them if they want to have it. From my understanding.

Anonymous said...

I'm not getting it for my daughter, so I wouldn't get it for a son either. There's too much we don't know, including how long it will last. Be a bit of a bummer to go through all that and risk the side effects and then get HPV down the road anyway, right?

Mary Ann said...

I would absolutely get Gardasil for both my boys. At age 50, my husband was diagnosed with cancer of the tonsil, which was likely caused by HPV. In fact, HPV is now thought to be one of the primary risk factors for head and neck cancers. After seeing what my husband went through, there is NO WAY I want my boys to go through the same thing. NO WAY. And if there's a vaccine that can prevent that, I'm signing up. It's idiotic that this vaccine is available to girls but not to boys. Who are the girls having sex with?? If you want to prevent this infection, which can cause cancer in BOTH sexes, then let both sexes choose vaccination.

Anonymous said...

Mary Ann is absolutely true, from my standpoint.
Why to vaccinate only girls? Boys also can have the anogenital warts. The thing is that the relationship between cancer and warts in men seems not to be very strong, but if we can prevent men spreading the disease it will be killing two birds with one shot. On top of that, we'll never know our boys sexuallity and I'd rather vaccinate my boys before start having sexual intercourse that found out later that they are gay and they have a disease that I could prevent.

Anonymous said...

I'm a straight 27 year old male and i'm looking into vaccination for a variety of reasons; not the least of which involves protecting those whom i have relationships with. There's no reason why i should be an agent in spreading life threatening viruses. Its a series of shots for me that can prevent cancer in others. Small sacrifice on my part.

Kristin said...

Good attitude--as a woman I sure appreciate it when guys look out for their partners, and as a mother particularly so.

I'm not getting it (at this point) for my daughters, because at a 17-45% efficacy I don't think the risks are worth the potential benefits and I believe that there are a couple of better options coming down the pike. However, if I were to get it for a daughter, I'd sure get it for a son, too.

To the last poster--please also be aware that there are risks if you get the vaccine and you already have HPV. Background info supplied to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May 2006 noted that when the vaccine was administered to women with a dormant or harmless form of HPV, the virus became activated, increasing the likelihood of precancerous lesions developing by 44.6 percent. VRBPAC not unnaturally expressed concern.

So if I were considering getting it as a sexually active adult, I'd want an HPV test first.

Anonymous said...

Kristen -- Gardasil is nearly 100% effective against the target viruses, not 17-45%.

National Cancer Institute: "FDA-approved Garasil prevented nearly 100 percent of the precancerous cervical cell changes caused by the types of HPV targeted by the vaccine for up to 4 years after vacciation." (They are awaiting more data to prove length of effectiveness)

I'm an older 20-something male and I have tried to seek out the vaccine already.

Carol said...

I will absolutely get the vaccine for my son as soon as I can. I can't believe that it's not already available.

Kristin said...

To last anon poster:

Yes, Gardasil is effective against HPV 16 and seems to be pretty good with the 2 strains (forget which) that cause genital warts.

However, there are at least 40 strains of HPV out of more than 100 that can cause cancer and Gardasil is not effective against them. In fact, 16 was already being replaced prior to Gardasil, according to one study. Replacement disease is a serious possibility, and when replacement diseases occur, they tend to be worse.

The 17-45% efficacy figure came from Merck's own studies and is consistent with prior studies. So you're right--it's effective against the targeted strains - but that doesn't mean you're fully protected from HPV. Very, very far from it.

Even if you are willing to risk any side effects of the vaccine, which are still unproven but still might give pause for thought, you still are at risk from HPV and at the very least should continue with annual Pap smears.

Personally, I'd prefer to wait for the far more effective preventatives just down the pike, but everyone needs to educate themselves and then make their own choice. There are NO risk-free choices.

Anonymous said...

I think it's great that they want to approve gardasil for men. I am 24 and I have HPV and got the gardasil vaccines after I already had HPV, it actually cleared up my HPV sypmtoms (got Gardasil in 2007, and haven't had anymore symptoms ever since). Unfortunatley my husband who is 26 has the HPV symptoms as well so we are waiting patiently for Gardasil to be approved for men, hopefully it will clear up his HPV symptoms as quickly as it did mine. Nothing else that has been given to him for g. warts has worked. As for me I tried a couple different things for g. warts and nothing seemed to work either, they seemed to have cleared up shortly after I got my first gardasil shot. So any one with these similar problems, I would recommend trying out Gardasil. I also had my mom take in my 17 yr old sister for the shots, she got the same reaction as I did, just a littler pain in the injections site for the day.

Kristin said...

That's exciting about your warts. You should contact Merck, though, as according to all current information, including Merck's literature, Gardasil does not clear up existing HPV infections. In fact, according to their early studies, Gardasil can cause existing dormant infections to become persistent.

If your experience is different, you should definitely let them know.

Anonymous said...

AS a response to one of the comments earlier to Anonymous. The one who had g warts and got the gardasil shots and it cleared up her symptoms.

My girlfriend who was 24 when we got together, got the shot in the early stages of our realtionship and never had any syptoms of g warts.

I on the other hand am now a 25 year old male and have been dealing with g warts for over 2-3 years now. I am glad my girlfriend did not have to go through what I am going through.

But the purpose of this post is that I went to my general doctor and asked for the gardasil shot. He debated me at first but I stuck to my wants and pretty much demanded I get it. He eventully caved in and gave me the Gardasil shots. I am hoping they clear up my symptoms of this annoying and ugly thing.

So what im trying to say is dont wait till it gets approved for your bf to get a shot. Have him go to his doctor and have him demand it. Tell the doctor youve resaerched it online and you want it. Thats what I did.

Good luck to the both of you.

Anonymous said...

I'm a 31 yo male with HPV. Although my symptoms are minor, what would happen if I were to follow a Gardisil treatment program? Is it a waste of time?

Kristin Johns said...

Gardasil does not cure existing infections; it's a preventative only, protecting against 4 strains of HPV out of more than 100.

You should talk to your doctor, but IMHO you would do well to rev up your immune system to help it shrug off the infection you have. Get sufficient sleep, quit smoking if you smoke, eat plenty of fruit and veg, exercise, and take immune boosters like Jade Screen/ astragulus.

Also, make sure you protect your partner by using condoms (which help, although HPV is spread skin to skin, so they're only about 70 percent effective) - maybe use a lubricant containing carageenan if it doesn't clash with the spermicide in the condom.

Anonymous said...

I'm a 28 year old male who had the 3 shot series about 3 years ago (whenever it first came out). I had a doctor that used it "off label" and I have had no problems at all. In fact, my insurance even picked up the tab on it so it didn't cost me anything either. Overall I'm content with my choice to get the series. If I can help myself, and help prevent the spread of a disease, I'm going to do it. Though it has not been officially approved by the FDA, I'd like to hope that it offers males some protection too - so I don't mind being a lab rat :)

Anonymous said...

okay everyone, im new to all this! what if i have hpv, the types that causes cervical cancer can i give it to my boyfriend? Can he get cervical cancer? should he go get tested for that? i thought there were no cervical cancer types found in men! i'm so confused!

Anonymous said...

Yes, you can certainly spread HPV to your boyfriend and he is at a very small risk of developing very, very rare cancers. (None of which are cervical cancer, given that he doesn't have a cervix.) (unless he's had a sex change operation!)

You should both be very careful about taking care of your immune systems so that you, like the vast majority of cases, can shrug off the HPV. Most cases resolve themselves.

Anonymous said...

my God! Imagine we can eradicate cervical, penile, anal and oropharangeal cancers all at once: a new silver bullet for Public Health! ONE vaccine to FOUR cancers! I think it's a no-brainer.

Kristin Johns said...

IF we could eradicate four cancers...but Gardasil won't do that by even the wildest stretch of imagination.

Brian said...

I am a man 20 years old and I got the Gardasil vaccine and I have not had any problems. The only thing that I see that is bad is about 20 minutes there is a lot of pain and a scale 1 to 10 it was a 10. But, what is a little pain compared to the viruses?

Anonymous said...

I am a 22 year old man, at age 21 I was exposed to HPV genital warts. I was my first time I ever had any sort of sexual intercourse. My partner wasnt aware tha she was HPV until 2 months after she informed me about it. I currently in a middle of a break out and I'm telling it is not fun, the fact that Ih have these warts. my urologist has to burn them off leaving me scabs that will heal and go away. however the embarrassment and the shame that I have to go through. I did tell me friend about the vaccine and he is very interested to get unfortunately he cannot find the vaccine. If anybody knows or can help me out please. We are located in the NYC area it would be greatly appreciated.
thanks

Heather said...

Yes, this is great news for boys, men and mother's who want to protect their sons from HPV, but a lot of people aren't seeing the bigger picture. HPV often goes unnoticed in boys for years, and maybe even forever, but they still end up spreading it to women. It shows up more often in women. If the male population has the option to get the Gardasil vaccine, it won't only protect them, but it will also protect the spreading it. Yes, we want to reduce the number of cases in men and women, but what causes the cases? The spread of it. If fewer people get HPV, fewer people will be spreading it. The males getting Gardisil doesn't only help the males, it helps everyone.

Brian said...
This comment has been removed by a blog administrator.
Kristin Johns said...

Note: all "comments" that are ads will be removed.

Anonymous said...

Absolutely NO! Better do your homework here. There are dangerous risks for young girls including Death online blogs. Just Google Gardasil for yourself. There is money to be made in this industry, beware who you trust. The FDA has been bought here. My girls are Never getting this one. Side affects are very risky. If I had any young boys- equally, NO way on this vaccine. Do your own homework.

Anonymous said...

I am a 22 year old male and learned that I have hpv two days before Christmas (was not happy at all) I have g wartz...I don't like them at all. I went to the clinic because at the time I didn't have any health insurence...the doc (who didn't make me feel to great about my situation) froze them off. They have came back but I really don't feel to comfortable with him.

Any way...I've been hearing about this vaccine and I'm wondering if it will clear my breakouts? I do smoke cigs...a lot and a lot of 420...I'm wondering what should I do. I hear that if my immune system is strong I can fight it off...or should I just get the shot? Please some one help

Kristin said...

Pot definitely alters the immune system--last I heard, in a good way if you have an inflammatory disease but in a very bad way if you are exposed to a virus--and obviously, HPV is a virus. Smoking makes you up to 27 times more likely to get a persistent HPV infection and at least twice as likely to get an HPV-related cancer.

So yeah, your 420 and cigarette habits are very possibly the reason your immune system didn't just shrug off the infection. Sorry, but there it is. If you can rev up your immune system by significantly changing your lifestyle and adding lots of vegetables and fruits to your diet, you stand a decent chance of throwing off the infection now. You need to exercise regularly and get enough sleep as well as stop smoking stuff.

Gardasil doesn't cure existing infections so there's not really any point in getting the shots.

We've all done stupid things to our bodies. You're not alone. But the intelligent thing is to change your habits once you realize that they're seriously screwing up your health. Good luck.

ERIN said...

I allowed my Son who was 13 to take the vaccine and he as had nothing but adverse effects from the drug since. He has been having, fatigue,migraines,tingling in his legs and hands, and passing out all since he had the vaccine 2 months ago. They are testing him for MS and Lupus now. I hope to have results this week. Think twice about this drug people it is KILLING CHILDREN!! Don't listen to your Dr. or you might have the same guilt I feel right now for allowing them to give him this stuff.It does not work for life it only last for 3 years in boys and protects girls for 5, so truthfully when your children are at the age they are becoming sexually active the drug will not even be working anymore. DO YOUR RESEARCH. I wish I would have.

MG said...

Do not give this vaccine to your son or daughter! My 18 yr old son just had the first shot two days ago. He had a terrible headache all night with body shakes and pains in his legs, pelvis and back He has never had such a reaction to a vaccine and he has had all his childhood and adolescent shots, plus the pneumovax, menactra Dtap and yearly flu shots. There is something WRONG with this Gardasil vaccine!!! I hope there are no more adverse reactions to come. We are very worried.

Anonymous said...

Just make a cure. Since doctors don't look into it enough I wonder if the government put this shit out like all other diseases that can't b cured that all of sudden cause a great epidemic. Does anyone know when hpv first came on the seen.

Anonymous said...

Please, please do your research. Everyone is saying that this prevents so many cancers but there is way too much research out there stating that since giving girls this vaccine, normal PAP smears have DECREASED. There is so much we don't know about how this will effect out children long term. Too much of a gamble to subject my child to. How about educating your child(ren) on obstaining from sex (all types) until you are in a committed relationship? Educate them on what could happen and the risks? No vaccine can cure something without causing other problems. pharmaceutical companies are BIG business. They care about the bottom line - not your child. Think about this - if everything was prevented/cured, they would be out of business. They won't let that happen.