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THANK YOU TIM! I am "sick" from all the emails I receive from AHCF asking me to write our government and stop further research into this VERY important advancement in the treatment of HIV/HIV prevention. Information is vital for our community to correctly respond to the epidemic. As we have seen over the last 20 years, ignorance = death. Why not provide a means to stop transmission of the HIV virus? No (or reduced levels of) transmission would be a welcomed addition to the current risk reduction model most informed medical professionals subscribe to. This form of treatment might help to decrease those persons at risk of infection who do not have the luxury of requiring their partners use a condom. Women in many countries are denied the right to protect themselves by using condoms (male or female versions). This form of prevention could be of great use. Enough with the drama.. Information saves lives.
for all the hostility directed at the FDA, Gilead and "Big Pharma" in general, i have yet to see a single comment anywhere addressing the issue of poor adherence to PrEP...it seems to be accepted as a given in the "real world". HIV medications only work for the adherent, and i see very little attempts at offering POZ and at-risk people even a basic education in Evolutionary Microbiology...specifically, that microbes exposed to toxins (such as HIV meds) will quickly produce mutated/resistant versions of themselves if HIV drugs are not taken faithfully. I find many HIV+ people fairly oblivious to this truth, despite all the pamphlets available that warn of resistance. I expect similar levels of scientific ignorance amongst the HIV- at-risk populations...we need to educate our peers better in this regard. there is no good reason to fight FDA approval of PrEP, doing so will not provide leverage for lowering ARV pricing, nor will it help the ADAP waiting lists. These are separate issues requiring and deserving of separate focus. All that fighting PrEP approval by the FDA will achieve is making some doctors scared to provide PrEP to patients that need it. some of those patients will go on to seroconvert as a result. i see many parallels with the contraception/abortion debate here: many prevention activists seem to fear PrEP the same way they fear "Test And Treat", as some sort of back-door rejection of the "use a condom every time" message they have pushed for decades. that message is no panacea and never will be, no matter how much or for how long it is pushed...yet many seem to feel that "if you don't want to use condoms then you deserve HIV". many abortion opponents feel that pregnancy is the proper consequence of sex, and if it amounts to a punishment, so be it. many activists ostensibly dedicated to HIV prevention very definitely seem to feel that HIV-infection is the proper and deserved consequence of bareback sex...and if it amounts to a punishment, so be it. this attitude is addled, but it appears quite widespread.
A little note about AZT, we know that it was harmful in the full doses prescribed in the 80's and I watched my first partner have hope and then go from hope to death, from his bone marrow being drain out by overdosing of the prescribed AZT and I thank God and him for having the courage to lead the way in new HIV treatment options, for with out him and many others that die for us HIV people, than many may not be on safer treatment now, however AZT became one of the most prescribed safer drugs in HIV cocktails in small doses for decades and worked for many and many are still taking small doses, plus a flood of new drugs in competition came to light because of one drug. It is kind of like sugar in moderation it is not harmful, but in super doses it can be harmful. Like an aspirin, if taken in moderation, it is safe and effective, but take a whole bottle then it is unsafe. I am not tiring to be rude, but for some reason D.C think tanks that help mold new public policy believe that the public doesn’t have a brain and are to stupid to take control of their healthcare, and I find that offensive to say the reason some have assess is that the other are not educated enough to follow directions on the label to do their own research or will sell the drugs for food or even worst a small number my sell their drugs for illegal drugs , in that case, we might want to take bleach off the market for some may drink it by mistake. Even better, let us go back to only allowing the educated to vote for in the past some believed the uneducated are not smart enough to vote for a representative. This proposed policy is not just about HIV people or non-HIV people or MSM or TSM, it is about assess to affordable safe treatment and knowledge that is available now, for many progressive counties have Over the Counter treatment options that reduce healthcare cost allowing people to go buy preventive treatment with out going through thousands of dollars in doctor visits, lab cost, over and over again and then to buy an over price drug that may work. (How can a market place drive prices down in healthcare, if four powerful unions like doctors, labs, pharmacists and insurance companies have their hands and control in the treatment options with out regards to the consumer?) We must change our old ways of thinking about healthcare education, prevention and treatment to empower the consumer to take action in research, informed decisions and obtainable open assess to treatment options with patient safety being the focus and the patient being in control of the directions and out comes with professional advice in the process, with out having to bribe doctors, big labs i.e (Abbot), pharmacists (i.e CVS, Walgreens) and insurance companies to allow open assessable treatment options and transparent knowledge for all Americans.
The issues surrounding PrPE have yet to be fully identified! This is going to be a very wild ride through unchartered terrain. Every PrPE meeting I attend I feel sucked back into time when we were demanding AZT be made available at any cost. Is history repeating itself?
Fr Writing for GNPUSA healthcare open letter publication, GNPUS
Writing for GNPUSA healthcare open letter publication, GNPUSA is for opening up Pre-exposure prophylaxis or PreP for over the counter sale from the FDA, to create fair and free trade for the American Healthcare consumer, if it is safe and effected, Also just like we are for rapid HIV home screening kits over the counter and safe microbicides over the counter and over the counter clean needle access too. Let’s get the facts straight for a moment concerning PrEP, for it is now available and assessable to some, like Doctors, first responders and the informed, along with free access to HIV positive mothers to stop the transfer of HIV to a new borne infant in most USA counties and Truveda is just a new generation of PreP and can be prescribed off label to the informed, educated and for those who have money to purchase it. If this HIV prevention tool works well like the first generation of PreP treatment for pregnant mothers and infants, which successfully stopped all most 99 percent of Mother to Child transmissions of HIV infection in the USA. Then open assess of PrEP could reduce new HIV cases safely for many, until marriage or once a loving monogamous partnership is obtain for many, if marketed right and safely in unity with our communities and within AIDS inc. Then logic tell us that new HIV infections might be reduced by 25 percent globally to knock out 100s of thousands of new HIV infections from accruing globally. Yes, the HIV morning after pill or morning before pill that is safe called PrEP needs to be accessible to all people, not just for First Responders, Doctors, Nurses, Police, Government Employees and Pregnant Mothers, but for all people, including prisoners should have access to these medical treatments. If Pre Exposure Prophylactics (Pre-Exposure Pill) (PrEP) could stopped new HIV infection and what a blessing it would be to start turning the tide on New HIV infection while savings lives and huge savings in Medicare and State Medicaid expenditures or the people's monies. If PreP and related social marking education reduction new HIV cases by 25 percent a year then the proof would be for all to see and if it did not as in all fair and free market places then PreP would go away.. The new knocking it out message for preventing new HIV cases needs to have a demonstration projects, in major cities to expand HIV prevention and HIV Education and the this new toolbox could look like this, beginning with Healthier Relationships, Condoms use, "Don'T do it, don't do it" message, and 3 new concepts , Over the Counter (OTC) fair access to rapid HIV home screening Kits for private home uses, OTC Safe Microcopies, OTC Safe affordable PrEP , and Over the Counter Clean Needle access, making fair knowledge and creating life saving enterprises in knocking out new HIV infections and Hep C too. Again, these combine tools old and new would cause HIV to be discussed more openly and could reduce new infections just in the social media discussions for many and bring new conversation around Healthcare Treatment and Equal Access in Fair and assessable healthcare knowledge, treatment options, prevention, and improve patient safety for the consumer to know their options to stop New HIV infections within the USA and beyond. FDA must approve and allow the free market place to move forth in hopes Gilead will create a fair price and help create a free market place for Global Assess to many which GNPUSA believes is a win, win for our communities to strive for eradicating new HIV infections.
I agree!!! I really do. Of course we don't want people to become infected...but then, what about those who are infected? I guess i'm concerned too about those infected who can't get medicine, who are sick. I mean, Elizabeth Taylor is gone and we didn't find the cure in time for her to see....can we find it for those who are sick? Please!
Great job, Tim. I completely agree with you that the primary challenge is holding Gilead and our health care infrastructures responsible for doing the right thing re: pricing, education, monitoring (esp. population level resistance monitoring) etc. And is anyone other than me concerned about creating street market (AKA black market) demand for these drugs? If I am dirt poor and getting Truvada for treatment, how am I not going to sell it on the street when a jumped up demand for it exists among affluent people who want it for prevention but don't want to go to an MD and get the condom lecture? Seems to me that there are some pretty serious ethics questions to be addressed there, also. Just one woman's opinion.
James Cooper
News flash.. there are "street" versions of every FDA approved drug where there is a demand. I have even heard of pain management clinics which prescribe addictive drugs to persons who do not actually need them except to get high. Imagine that. Educate our communities on the best use of this drug for the prevention (risk reduction of) transmission of HIV. Anything less is not acceptable. Police people, not medications/treatments.
May 1, 2011