PrEP: Third FDA Anniversary

Three years ago today the FDA approved Truvada as a daily HIV preventive. Since then PrEP has remained controversial. Powerful naysayers like the AIDS Healthcare Foundation run anti-PrEP ads in a major publications while other HIV/AIDS groups and health departments in major US cities vigorously promote PrEP for at-risk populations. In another PrEP promotion, the hook-up app Scruff is today supporting PrEP Action Day on social media. Meanwhile, the guy in the clip below delivers a raunchy anti-PrEP rant.

FDA To Ease Gay Blood Ban

The FDA today followed up on its December hearings and announced that the lifetime ban on blood donations by gay men will soon end. But under the new rules, gay men will only be allowed to donate if they have been abstinent for the previous year. The new policy is currently only in draft form and the public will have 30 days to comment. Both Sen. Tammy Baldwin and the HRC say the change isn't good enough.

"While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said HRC Government Affairs Director David Stacy. “This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology. We are committed to working towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve.”

The one year ban was adopted in recent years by Britain, Australia, and several other countries. The AMA and the American Red Cross have called for lifting the US ban entirely.

FDA Approves "Functional HIV Cure" Trials

Via Medical Daily:

A possible “functional cure” for HIV has recently been granted FDA approval for further human testing. The method uses genetic modification to cause a specific mutation in the white blood cells of HIV patients which mirrors those found in the naturally immune. It has so far shown to be both receptive and long-lasting.

The novel therapy involves taking stem cells from HIV-infected patients and using a gene editing tool to cause them to form into white blood cells with a specific mutation. The mutation affects a protein known as CCR5, and interferes with the virus’s ability to latch onto blood cells. The mutation occurs naturally in a small percentage of the world’s population and gives these individuals a life-long resistance to HIV infections. Although the virus may remain in their body, without being able to enter the T cells, it cannot replicate and therefore will stay at low numbers, uncompromising the immune system.

In theory, when these genetically edited stem cells are reintroduced into HIV patients they will repopulate the body with cells possessing the same mutation. This would give the patients the same lifetime resistance to the virus’s harm with just one procedure. The method was developed by Sangamo BioSciences Inc., but has also been tested in early human clinical trials by drug research company Calimmune. 

San Francisco's KQED reported on this development on Friday.

(Tipped by JMG reader Paul)

GLAAD & GMHC Enlist Alan Cumming As Spokesman For FDA "Celibacy Challenge"

From the Celibacy Challenge site:

The FDA recently announced that gay and bisexual men may finally be allowed to donate blood after being banned for life since the ’80s—but only if they remain celibate for one year. So straight guys can have safe sex with woman after woman and still donate blood. But gay and bi men who have had safe sex for an entire year—even with a monogamous partner—would still be banned. Sounds like discrimination to us. Sign this petition to pressure the FDA to screen all prospective blood donors based on risk, regardless of their sexual orientation or gender identity.

You'll enjoy the clip.

Freep This FDA Poll

On the lower left side. (Tipped by JMG reader Spur)

FDA Eases Gay Blood Ban, Donations Allowed After One Year Of Celibacy

Via Reuters:

Gay men will be able to donate blood one year after their last sexual contact, the U.S. Food and Drug Administration said on Tuesday, under a proposal that will be introduced early next year to end a ban that has been in place since 1983. Scientific evidence shows the move will not create risks for the nation's blood supply, the FDA said. The policy change is expected to boost the supply of donated blood by hundreds of thousands of pints per year. Blood donations from gay men have been barred since the discovery that HIV, the virus that causes AIDS, was being transmitted through transfusions.

The FDA said it will issue draft guidance on the policy, hopefully early in 2015. It would then review the comments and issue final guidance "as quickly as possible," Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, said during a press briefing. An FDA advisory committee met this month to discuss issues around changing the policy, such as the effectiveness of new blood supply tests for HIV infections. In November, an advisory committee to the U.S. Department of Health and Human Services recommended a one-year deferral. The FDA stopped short of eliminating the ban for gay men altogether. Marks said during the briefing that scientific evidence for a ban shorter than a year was not "compelling."

The ACLU has slammed the change:

"The FDA's proposal must be seen as part of an ongoing process and not an end point," said Ian Thompson, ACLU Legislative Representative. "The reality for most gay and bisexual men -- including those in committed, monogamous relationships -- is that this proposal will continue to function as a de facto lifetime ban. Criteria for determining blood donor eligibility should be based on science, not outdated, discriminatory stereotypes and assumptions." The FDA blood donation policy, which has been in place since 1983, prohibits any man who has had sex with another man, even one time, since 1977 from donating blood. The American Civil Liberties Union previously submitted comments urging the FDA to reassess its policy based on current scientific evidence.

Similar sentiments from Lambda Legal:

This is a step in the right direction, but blood donation policy should be based on current scientific knowledge and experience, not unfounded fear, generalizations and stereotypes. Merely changing the parameters of this outdated policy does not alter its underlying discriminatory nature, eliminate its negative and stigmatizing effects, nor transform it into a policy based on current scientific and medical knowledge. Within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV. Therefore, a deferral of more than two months--for anyone--is not necessary and does not noticeably enhance the safety of the blood supply. Furthermore, donor deferrals should be based entirely on the conduct of the potential donor and not on sexual orientation, gender identity or the perceived health status or risk factors of the donor's sexual partners.

The reason is straight-forward, and is a foundational principle of our prevention efforts: an adult person becomes HIV-positive--or acquires another blood-borne pathogen--only after engaging in activities that present a risk of transmission. To base deferrals primarily on prevalence within certain communities rather than behavior could serve to disqualify other segments of the population based on race, sex and where they reside--a very slippery slope toward more easily recognizable forms of illegal discrimination. If we are serious about a policy that is truly most protective of the blood supply, it will treat all potential donors the same and base any deferrals on the conduct of those potential donors within a scientifically justified 'window period' prior to donation.

FRC: Keep Gay Blood Ban

Via press release:

The FDA created the rule -- not out of prejudice, but precaution. Now, a growing chorus of liberals is insisting that federal agencies should ignore the risks so that homosexuals feel “more accepted” in society. In other words, the Left is willing to taint the U.S. blood banks to make a political point. If the FDA wants to protect people’s health, it has to be selective. The government can’t afford to contaminate the blood supply just to validate people’s risky sexual behavior. Not to mention, Peter points out, that the very small size of the LGBT population (2.3% according to this year’s CDC survey) means that any potential benefits to the blood bank would be “marginal.” In fact, the only thing they would add with 100% certainty is liability. Yet every year, the government wastes taxpayers’ time and money debating what is nothing but a naked push to normalize and celebrate homosexual behavior. The blood donation policy doesn’t exist to serve a political agenda -- and it shouldn’t be changed to advance one. Even if the new screening can detect virtually all tainted blood, no test is completely safe. And the government shouldn’t be willing to risk America’s blood supply to prove it.

FDA Mulls Gay Blood Ban

Via the Washington Post:

The Food and Drug Administration during a two-day meeting starting today will consider lifting the ban that was put into place in 1983 amid fears — and little understanding — of the AIDS virus. An FDA advisory committee last month recommended that the agency lift the restriction, but only for men who hadn't had sex with other men for at least a year. The scientific and medical communities have increasingly rejected the ban currently in place in the United States. The American Medical Association, the nation's largest physician organization, voted last year to oppose the ban, calling it discriminatory and not based on sound science. Instead, the AMA urged federal policymakers to take a more personal approach assessing each individual's level of risk. The approach recommended by the FDA advisory committee last month falls short of that standard. And it still falls short of what a number of other countries have done to allow blood donations from gay and bisexual men.

Australia, Hungary, and Japan have all recently instituted one-year bans like the one being considered by the FDA. Among those testifying against any change today was FRC vice president and non-scientist Peter Sprigg, who is best known for declaring that sodomy should still be illegal in the United States and that American gays should be exported rather than allowing foreign gays to immigrate here.

Matt Barber's Site: AIDS Patients Should Sue Groups That Promote Safer Sex

In a post on Matt Barber's website, infamous anti-Kinsey activist Judith Reisman today declares that AIDS patients should file a class action lawsuit against "condom pushers" because the FDA has never approved condom use for anal sex.

The reality is that condoms are manufactured and approved every day for natural, vaginal sex, not anal “sex.” They are not effectively designed to protect from disease those people who engage in sodomy. Such a lawsuit should target the AIDS Healthcare Foundation, Planned Parenthood and a myriad of teachers and school systems, too many to count, that have taught that anal “sex” (traditionally termed “sodomy” or “buggery” under British-based legal codes) as not so different than natural coitus. The result of a class action suit should be the requirement of a label, a la cigarette packs, that states: “This condom has never been approved by the FDA for penile/anal intercourse.” Due to the lies that have told, people who practiced sodomy are under the tragically mistaken notion that a condom is effective protection from disease. Those who have believed this lie and have contracted AIDS or an STD (and the loved ones of those who’ve lost their lives) have a cause of legal action.

Reisman's post comes in support of crackpot Hawaii state Rep. Bob "Crazy Eyes II" McDermott, who is leading a campaign against sex education in public schools.

RELATED: Last month Men's Journal reported that a Los Angeles-based company founded by an HIV+ gay man is working to get FDA approval for an condom that would be marketed for anal use.

FDA Approves New Hep C Drug

Via press release from the CDC:

Today, the FDA approved an important new treatment for chronic hepatitis C. The drug, sofosbuvir, is a major advance in the treatment of a disease that affects approximately 3 million Americans and causes more than 15,000 deaths in the U.S. annually. Today marks a landmark advance in the treatment of hepatitis C, opening up new opportunities to stop the spread of this virus and the ravages of this disease. However, new therapies only work if people receive treatment – the potential of these and other treatment advances hinges entirely on our ability to get more people screened and into care. Right now, most Americans with hepatitis C don’t access treatment because they have no idea they’re infected.

FDA Zaps Online Genetic Testing Firm

The FDA has ordered the genetic testing company 23andMe to cease selling its products.

A high profile effort to make consumer-oriented genetic testing commonplace was derailed Monday when the FDA told Mountain View-based 23andMe to stop selling its personal DNA analysis kits, claiming that the $99 tests might be based on bad science. The agency pointedly said that 23andMe, which is heavily backed by Google, has failed to fulfill many requests for proof that its test is safe and reliable, and that it provides consumers with the kind of information they need to make sound decisions about everything from cancer to dementia. The private company characterizes a customer’s relative risk for about 250 diseases and disorders based on a partial analysis of genes in their saliva. The tests -- performed with chips from San Diego’s Illumina -- also suggest how a person might respond to some medications, including the blood thinner warfarin. All results are based on scientists' limited understanding of genes.

Judging merely by my Facebook feed, most folks have been using 23andMe in the hope of unearthing some "exotic" family history, not to investigate potential susceptibility to diseases.

Federal Judge Orders FDA To Drop Age Restrictions On Morning-After Pill

A federal court today ordered the FDA to drop the prescription requirement for girls 16 and younger that wish to purchase the over-the-counter medication Plan B, which prevents pregnancy.

In a decision in a lawsuit filed by advocates, the judge, Edward R. Korman of Federal District Court, ruled that the government’s refusal to lift restrictions on access to the pill was “arbitrary, capricious, and unreasonable.” Judge Korman ordered the F.D.A. to lift any age and sale restrictions on the pill, Plan B One-Step, and its generic versions, within 30 days. “More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced,” the judge wrote. “The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”

The right wing has long mischaracterized Plan B as an "abortion-causing pill" and as an "abortifacient." In fact, the drug merely prevents ovulation.  You can expect screams of outrage across Teabagistan today.

UPDATE: Right on cue, blowhard Bill Donohue.

A 12-year-old girl in a New York City school cannot be given an aspirin by her teacher, even if she has a fever. The same girl cannot buy a large soda during lunch time because Mayor Michael Bloomberg has decreed that it is not good for her. But she can be given a pill, unbeknownst to her parents, that could arguably abort her baby. Neither Judge Korman nor Mayor Bloomberg has said what the aspirin-denying teacher should do if he sees a girl reaching for a large Coke to down her abortion-inducing pill. This is what we’ve come to in our culturally schizophrenic society. Our moral code is patently incoherent, and the contempt shown for parental rights is astonishing. Hopefully, this imperial decision will be overturned.

FDA Approves 4-In-1 HIV Med

The FDA has approved Gilead's latest combination once-a-day HIV pill which has been known as "the Quad." Via FDA press release:

Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection. “Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “New combination HIV drugs like Stribild help simplify treatment regimens.”

RELATED: The FDA recently approved Gilead's Truvada as a daily HIV preventive for high risk groups. As noted above, Truvada is part of the newly-approved medication. Last month the FDA also approved an in-home HIV testing kit. That item reportedly comes on the market in October.

FDA Approves Truvada As HIV Preventive

The FDA today approved Gilead Sciences' Truvada medication as a daily HIV preventive for "some high-risk populations." The medication had been under FDA review for such use for several months and today's decision was strongly opposed by some HIV activism groups although a coalition of other groups endorsed the plan. Gilead has published a press release:

Data supporting the approval of Truvada for PrEP came primarily from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the U.S. National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation, and Partners PrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. The iPrEx and Partners PrEP trials found that Truvada reduced the risk of acquiring HIV infection by 42 percent and 75 percent, respectively. Several other clinical studies also support the use of Truvada for HIV risk reduction. "This approval is a major milestone in our 30-year fight against AIDS," said Robert M. Grant, MD, MPH, Betty Jean and Hiro Ogawa Endowed Investigator, Gladstone Institute of Virology and Immunology, University of California, San Francisco and lead investigator of the iPrEx trial. "The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world."

The group that most loudly protested in advance of today's decision was the AIDS Healthcare Foundation, which published anti-Truvada ads in a California newspaper near the Gilead headquarters and sent the below mailer to more than 50,000 homes in that area. The FDA's decision to approve Truvada as a PrEP medication was supported by the San Francisco AIDS Foundation. All groups concede that the long-term effects of a daily HIV medication by uninfected persons is not yet fully known.UPDATE: The AIDS Healthcare Foundation responds to today's decision.

“The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” said Michael Weinstein, AHF’s President. “From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support. And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an ‘…unknown or HIV positive status…’ is ‘contraindicated,’ it in no way actually requires HIV testing in any manner—just strengthening of the ‘Boxed Warning’ on Gilead’s packaging. The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.’

UPDATE II: The SF AIDS Foundation reacts:

“Today’s decision by the FDA heralds a new era in HIV prevention—one with great promise for expanded access to HIV testing and prevention counseling and support,” said Neil Giuliano, CEO of San Francisco AIDS Foundation. “The approval paves the way for increased work with the federal government and Gilead Sciences to ensure they realize the incredible impact they can now have to get Truvada to the communities that stand to benefit most, especially gay men and people of color.” “The groundbreaking decision by the FDA has widespread implications for efforts to stop the spread of HIV both here in the United States and beyond our borders,” said James Loduca, vice president of public affairs at San Francisco AIDS Foundation. “Now the hard work begins to ensure that health care providers, clinics, and our community know how and when to use Truvada—and to ensure that price and delivery systems are never a barrier to access for anyone who stands to benefit from it.”

FDA Approves In-Home HIV Test

Back in May I told you that the FDA was evaluating an in-home HIV test. Today OraSure Technologies received approval to begin selling the test kit to drugstores and online. The FDA announced today's decision with a press release and a warning:

The OraQuick In-Home HIV Test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result. Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

Bolding is mine. Shortly after my first post on this product, I managed to corner an OraSure executive backstage at the NYC AIDS Walk, where I grilled him about the possible abuses of the product by parents and partners and about the potential for self-harm upon a positive result. He told me that the company had considered all of that and had the position that those hopefully rares occurrences were outweighed by the potential for getting many more people on the necessary treatments.

GlaxoSmithKline Fined $3B By Feds

Drug giant GlaxoSmithKline has agreed to plead guilty and pay $3B in fines and restitution in response to multiple federal charges of marketing deception and product safety violations. Theirs will be the largest federal penalty ever paid by a pharmaceutical company.

Today's multibillion-dollar settlement is unprecedented in both size and scope,'' Deputy Attorney General James Cole said. "At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust - and this historic action is a clear warning to any company that chooses to break the law." Prosecutors said GlaxoSmithKline illegally promoted the drug Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18. The corporation also promoted the drug Wellbutrin from January 1999 to December 2003 for weight loss, the treatment of sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depressive disorder. GlaxoSmithKline CEO Sir Andrew Witty expressed regret and said they have learned "from the mistakes that were made."

GSK's sales force was also accused of bribing physicians to prescribe their products, dangling perks as wide-ranging as luxury vacations and tickets to Madonna concerts.

FDA Poised To Approve Home HIV Test

An FDA committee today gave preliminary approval to what would be the nation's first-ever in-home HIV test. The OraQuick rapid HIV test is already in use at many health clinics. Previous over-the-counter home HIV testing kits required sending a blood sample to a laboratory. The National Minority AIDS Council responds via press release:

“Approximately 50,000 individuals in the U.S. are newly infected with HIV each year,” said National Minority AIDS Council Director of Legislative and Public Affairs Kali Lindsey. “Even more alarming is the fact that one in five people living with HIV in America do not know it. The OraQuick In-Home HIV Test would provide an important tool to supplement current HIV screening efforts by providing an accessible, relatively inexpensive device that can be used in the privacy of one’s own home. This is especially important for minority communities, where HIV stigma often prevents individuals from utilizing traditional testing services.”

Some HIV/AIDS groups have warned that at-home HIV tests could result in self-harming actions when the result is positive. Others have expressed concerns about the potential for forced testing of teenagers by anti-gay parents.

UPDATE: Poz.com has more on the story.

Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone operator. The retail price is between $30 and $40. The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The retail price of the test is not yet known.

FDA Poised To Approve Existing Med For Daily HIV Prevention

The FDA has signaled that it is about to approve the usage of Truvada as a daily preventive for HIV infection among high-risk populations.

The Food and Drug Administration said Tuesday that Gilead Sciences' Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment." On Thursday a panel of FDA advisers will consider the review when it votes on whether Truvada should be approved as a preventative treatment for people who are at high risk of contracting HIV through sexual intercourse. The FDA is not required to follow the advice of its panels, but it usually does.

Most major AIDS groups have endorsed the usage of Truvada as a daily preventive. One notable exception is the controversial AIDS Healthcare Foundation, who recently launched a media campaign warning that the long-term effects of such medications remains unclear.

AIDS Groups To FDA: Approve Existing HIV Drug As A Daily Preventive For Infection

A coalition of major national HIV/AIDS advocacy groups is asking that the FDA approve the Gilead drug Truvada as a daily preventive or "pre-exposure prophylaxis" (PreP) against infection. Among the groups joining the demand are amfAR and the San Francisco AIDS Foundation. Via press release:

The PrEP sNDA for Truvada®meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review[4] introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

The press release notes the "unfortunate" opposition to PreP therapy voiced by the controversial AIDS Healthcare Foundation, which contends that the long-term effects of Truvada on the non-infected have not been fully examined. AHF has been vigorously lobbying to block the FDA from making the above-requested classification change.

FDA Approves HIV Vaccine Study

Promising news from the University of Western Ontario.

Kang said the vaccine, called SAV001, is the first preventative HIV vaccine approved for clinical trials to use a killed whole HIV-1 virus to activate the immune response in humans. The strategy has been used before to develop successful vaccines for influenza, polio, rabies and hepatitis A. Kang said these past successes for other viral diseases provide hope the Canadian-developed vaccine will work against HIV. The human immunodeficiency virus used in the vaccine has been genetically altered to render it non-pathogenic, or unable to cause disease. Kang and his research team then further inactivated the virus using chemicals and radiation. In the past, people did not use this strategy (using a killed whole HIV virus) because people did not know how to make a safer virus and people did not know how to make large quantities of it,” Kang said. “Now we have solved those problems by the genetic engineering of the virus.”