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By Rational Vaxxer
Why do some people think it's odd that clinical trials are held outside the United States? It's actually more common than realized. Why? There are many reasons but one main one is the cost. It is nearly impossible for start up companies that have viable products that could be tested but cannot raise 50-100 million dollars to get any headway in the United States. That cost is ridiculous. So let's look at the facts. . .
STAT analyzed FDA records ( https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm ) on the first 29 new drug approvals this year, 2017. (The agency approved two more new drugs in late August, but it has yet to post detailed information about their supporting clinical trials.) The findings:
• 86 percent of approvals were supported in part by data from trials conducted outside the U.S. and Canada.
• A new drug for amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, was approved in the U.S. exclusively based on trials conducted in Japan.
• In the 11 cases in which a detailed breakdown of the data was available, a collective 58 percent of patients were enrolled outside of the U.S.
• The trials were conducted in more than 18 countries outside the U.S., ranging from Russia to South Africa to New Zealand to Italy. (Some countries that hosted trial sites were not named.)
Info from https://www.statnews.com/2017/09/08/clinical-trials-overseas-data/
In conclusion and response to the haters and fake news media, (regardless of what side of the fence you are on.)
1. Dr Halford never broke any laws.
2. FDA rules are in place for the United States. NOT other countries.
3. St Kitts follows regulations under EU laws, no laws or regulations were broken.
4. Under EU Laws. The Names Patient Program allows doctors to administer medicine to individuals who have exhausted all other options. Outside the US, named patient programs provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country.
Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.
While I am not a fan of the current president, I do not see how it is constructive to attack investors who are willing to put up boatloads of money to help other people ( that they don't know, ) and further research that is going to help so many us. Why is this bad?
I think before people jump on the hate bandwagon and start vomiting their insidious opinions all over the Internet on how awful it is that a billionaire; who supported the current president is now an investor. Perhaps they should ask themselves "What have I done to help other people who suffer from herpes?" "What positive actions have I done to to make someone better?" I'm sorry but if all you have is nothing but hate and nothing to add to help others, then please remain in the herpes closet and shut the door.
I have created a group on Facebook called Theravax HSV1 & 2 as a platform for people to share their experiences from the Theravax Trails. This is a closed group. Please avoid any negativity as we already have enough of that in the outside world and we don't need it here on this group. You can share your experiences on the consultation, pre and post travel as well so that it helps every one make better decisions.
Members of this group can also help each other to travel together to get the vaccine (Not necessarily by means of funds) but just support as it's not always easy to go to a new country for an objective as strong as this. This group is for support. We are with you. <3
I urge the aspiring participants and the people who have been selected for the trails to join the Group and share their experience.
Im a 30 something year old mother of four. I was diagnosed five years ago. My soon to be husband had it and had no idea, never had an outbreak of a symptom and I had a terrible outbreak and was diagnosed and it's been from that July day that my world started crumbling.
I know you guys get it. Problem is, I have had a difficult time dealing with it. I have shut out my family, friends, and the hatred I have for my now husband grows by the second.
I have been feeling so down the last couple days. I have found it physically exhausting to even get ready for work. I only have about 2-3 breakouts a year and only take Valtrex when needed. For whatever reason I have had a small breakout this week. I am having nerve pain and I'm too ashamed to go to my doctor for more meds. My emotions are all over the place. Knowing I have to live with this for the rest of my life and there's nothing I can do about it makes me feel trapped inside my own body and full of anxiety. I think about who I used to be before this virus ruined my life and I have changed significantly. I am such an angry bitter person. I am so tired of being happy for everyone around me and putting on a show. I need therapy but the fact of the matter is that therapy won't take this away. Nothing I do will change this outcome. If it weren't for my kids I would end it all but I'm not that selfish.
I feel the best thing to do is divorce my husband cause I make his life hell for doing this to me. I feel so stuck.
So this is another post from me because, once again, I'm not sure if I'm having an outbreak!
I've only ever had two definite OBs;
My primary OB which was terrible, swelling, about 10 sores up to 5mm in diameter on foreskin and frenelum, painful and swollen lymph nodes in my groin, lasting about 2-3 weeks until I was back to normal.
Then unsure of if I was having them for about 3-4 weeks but I think it was just scare tissue from the healing sores.
About 5 weeks after initial OB my definite Secondary OB which was only 1 sore around 3mm on my foreskin, slight/no tingling, no pain, no swelling in my nodes, this lasted about a week until fully healed.
Now, I remember how the stinging, tingling, feeling felt of my Primary OB and I've never experienced that since, I am at around 10 months since my Primary OB and other than the above occurrences I've never been able to tell if I'm having an OB. All I've had is the occasional red dot that's around 0.5mm either right under my glans at the join to my foreskin or on the corona of my glans and it doesn't seem to ever act like a sore, doesn't blister, no pain, doesn't seem to be a little hole in my skin but more of a bump outwards and it hasn't been in the same place as my Primary or Secondary OBs. I can't seem to tell if I'm just experiencing redness, thrush, irriation or a popped blood vessel after sex with my girlfriend or masturbation. I'm starting to drive myself mad with checking in case I am indeed having an outbreak and I can't seem to find any information on this!
Basically what I'm looking for is descriptions of what you all experience with your OBs, HSV1 or 2? size of your sores, number of sores, location (glans? Corona? Frenelum? Foreskin?). I know that may seem weird but I need to see if what I'm experiencing is an OB. I think this may help a lot of people know what they're experiencing!
Thanks for any answers!
I've had issues with my lips for years including bad cold sores all throughout my childhood. Any crack or chapping of my lips would through me into a panic over what was impending. This is what caused me to be a lip balm addict, and honestly certain balms have really cut back my outbreaks. One such, which I found recently is a natural balm containing wild oregano oil. I've been putting it on before I go to bed nightly and have noticed a huge difference. I purchased mine off of ebay searching "oregano oil lip balm", and its called heens apothecary, but I'm sure there are others. Let me know if this helps anyone prevent outbreaks. I hope this helps me during the cold months.