AIDS nonprofit group faces union campaign

Medical staff members at the AIDS Healthcare Foundation are seeking representation by the National Union of Healthcare Workers, charging that care is suffering.

By Abby Sewell

September 24, 2013

A group of medical providers at clinics run by an influential but controversial AIDS-focused nonprofit group have launched a bid to unionize, saying that the organization's leadership has lost sight of its mission and patient care is suffering.

Doctors, nurses and physicians assistants in the AIDS Healthcare Foundation's Los Angeles and Bay Area clinics have been engaged in a behind-the-scenes struggle with the organization's leadership for the last two months.

On July 31, medical staff members submitted a petition to the National Labor Relations Board, announcing their desire to organize under the National Union of Healthcare Workers.

The foundation's leadership has contested the validity of the petition, saying that some of the employees involved in the union drive are supervisors not allowed to take part in union organizing.

The organization, with a budget of $750 million, runs a network of HIV and AIDS testing and treatment facilities around the world, as well as its own pharmacies. Its 10 clinics in the Los Angeles area serve more than 7,000 patients, many of them through contracts with the county.

Local providers say that those clinics are understaffed, that there is a lack of Spanish interpreters and that there has been a push to pack more patients into the schedule each day at the expense of quality care. They say their complaints have been disregarded and that the organization is focusing too much energy on political advocacy. Those include fights with the county and with the adult film industry over attempts to mandate condom use on set as a way to reduce exposure to social diseases.

"We support AHF's mission — that's why we're all here in the first place, but we feel like they're not really carrying out their mission," said Felipe Findley, a physician's assistant at the foundation's downtown clinic.

Kim Sommers, medical director at the organization's Hollywood center, recalled that one day the clinic was so over capacity that a patient suffering from chest pains was sent home by the lone over-stressed medical assistant on duty because no one was available to give him the electrocardiogram Sommers had ordered.

"He came back two days later and he ended up being OK," Sommers said. "But the point is, we don't want to wait for something horrible to happen."

AIDS Healthcare Foundation founder and President Michael Weinstein said the union process had been "tainted" by the involvement of middle managers.

"They've got an absolute right to form a union, but right now it's been organized by people in management, and they've put a lot of pressure on rank-and-file employees," he said. For their part, employees have filed complaints alleging that the executive leadership retaliated against them for their union activities.

Weinstein said the organization is indeed focused on patient care and that changes in scheduling policies were made because the organization had lost patients when they were unable to get follow-up appointments scheduled in a timely manner. He defended the organization's political activities as a core part of its mission.

"The advocacy is who we are, and I would argue that the advocacy we do has very much helped us to improve the care in our patient centers," he said.

The workers went public with their complaints as the foundation's leadership is heading into another political fight with Los Angeles County. The foundation says that the county's Department of Public Health is sprawling and inefficient and is campaigning for a measure for the June ballot that would create an independent health department in the city of Los Angeles.

The county Board of Supervisors voted 3 to 2 last week to go to court in an attempt to stop the measure from getting to the ballot. The board is scheduled to discuss the potential effects of the proposal Tuesday.

abby.sewell@latimes.com

Times staff writer Seema Mehta contributed to this report.

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AHF Launches First 1-minute “INSTI” HIV Testing Program in New York City

June 05, 2013 09:00 AM Eastern Daylight Time 

AIDS Healthcare Foundation will launch the program at the Brooklyn Pride Festival on Saturday, June 8^th, offering free one-minute results HIV tests through two mobile testing units

1-minute “INSTI” testing will be available on an ongoing basis through AHF’s new Out of the Closet Thrift Store in Brooklyn and through its mobile testing program

NEW YORK--(BUSINESS WIRE)--On Saturday, June 8^th, AIDS Healthcare Foundation (AHF) will make history as the first HIV testing program in New York City to use a revolutionary HIV test that provides results to people in just one minute. The program will be launched at the 17^th annual Brooklyn Pride Festival where free testing will be offered out of AHF’s mobile testing unit and the visiting Condom Nation van throughout the festival from 11:00 am to 5:00 pm. Free, confidential 1-minute INSTI testing will be available on an ongoing basis at AHF’s new Out of the Closet Thrift Store in Brooklyn (475 Atlantic Ave.) every Monday-Saturday from 10:00 am to 7:00 pm beginning on Monday, June 10^th. AHF is a proud sponsor of this year’s Brooklyn Pride.

 

What:		AHF launches 1-minute HIV testing at Brooklyn Pride Festival
When:		SATURDAY, June 8th 11:00 am to 5:00 pm
Where:		Brooklyn Pride Festival
		Park Slope on 5th Avenue from 3rd to 9th Streets
		AHF booth will be located at 5th Ave. between 4th and 5th Streets
Who:		Michael Camacho, MPH, NYC Regional Director, AIDS Healthcare Foundation
		AHF HIV testing counselors
B-roll:		Mobile testing unit and Condom Nation van offering free INSTI HIV testing
Contacts:		Michael Camacho, AHF NYC Regional Director, mobile 646.265.7460
		Lori Yeghiayan Friedman, AHF Assoc. Dir. of Communications, mobile 323.377.4312

Last September, AHF was the first HIV testing program in the United States to use the revolutionary HIV test when it launched a program to offer it at all of its Los Angeles locations last September. AHF now offers the test at many of its locations throughout Florida as well. For more information about AHF’s testing locations in New York and other parts of the U.S., please visit: www.freehivtest.net.

“With an estimated 15% of people who are HIV-positive unaware of their status, our hope is that the INSTI one-minute test removes a barrier that prevents people from getting tested regularly,” said Michael Camacho, NYC Regional Director for AHF. “Though the 1-minute test has been widely deployed in other countries in Africa and elsewhere over the past four years, it has only been available in the U.S. since last September. Unlike other tests that take 15 to 30 minutes for results, the INSTI™ test produces results in as little as 60 seconds—a revolution for testing in the U.S. – and, now, New York!”

bioLytical Laboratories’ one-minute HIV test, the INSTI™ Rapid HIV Test, was approved for widespread use in the United States in late July 2012 by the Food and Drug Administration (FDA). At the time, Whitney Engeran-Cordova, Senior Director of AHF’s Public Health Division, said, “The increased availability of the INSTI™ 60-second rapid test in the U.S. … is a game-changer and will allow for large-scale testing events and new ways for point-of-care testing in Emergency Rooms. Most importantly, it will lead to new techniques to reach people.”

According to a bioLytical statement of the time of FDA approval in July, “The INSTI™ Rapid HIV Antibody Test is the first rapid HIV test to meet the stringent requirements of the updated Clinical Laboratory Improvement Amendments (CLIA) guidelines, which pertain to the complexity of laboratory tests. A CLIA Waived test is categorized as a ‘simple laboratory examination or procedure that has an insignificant risk of an erroneous result,’ meaning the tests can be performed by untrained users at point-of-care (POC) locations across the country.” bioLytical also noted, “The INSTI™ Rapid HIV-1 Antibody Test, the world’s only proven 60-second test for HIV/AIDS, is being made more widely available to the U.S. population. Found to meet the CLIA Waived performance requirements for finger-stick blood samples, INSTI™ can now be used by HIV testers and healthcare providers in a significantly expanded variety of settings.”

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 200,000 individuals in 28 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Contacts

AIDS Healthcare Foundation
Lori Yeghiayan Friedman
AHF Assoc. Director of Communications
Telephone: 323-308-1834
Mobile: 323-377-4312
loriy@aidshealth.org
or
Michael Camacho, MPH
NYC Regional Director, AHF
Mobile: 646-265-7460
michael.camacho@aidshealth.org

Source

AHF Advocacy Against Gilead’s Truvada as HIV Prevention Yields Stronger FDA Drug Warning Label

October 11, 2012 09:52 PM Eastern Daylight Time

New warning label is welcomed by AIDS advocates who were astounded by recommendation by an FDA Advisory Panel earlier this year to allow Gilead to market use of its blockbuster AIDS treatment as a form of HIV prevention in uninfected individuals without any HIV testing requirement whatsoever

AHF and other advocates strenuously opposed use of the AIDS treatment as a form of HIV prevention pill, concerned about efficacy, medication adherence issues among uninfected high-risk populations; ‘Black box warning’ label on Truvada for prevention now recommends HIV testing every three months

WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences’ blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year. The new warning label is being welcomed by AIDS advocates from AHF and other organizations who were astounded by a recommendation by a Food and Drug Administration (FDA) Advisory Panel to allow Gilead to market use of Truvada as a form of HIV prevention in uninfected individuals, particularly when the panel—comprised of 23 physicians, scientists and members of the general public—also recommended that the FDA allow Gilead to market the drug for such use without any requirement for HIV testing whatsoever.

“From the beginning, AHF and many other advocates strenuously opposed use of this well-established AIDS treatment as a form of an HIV prevention pill, concerned about both the efficacy of the treatment as well as medication adherence issues among uninfected high-risk populations,” said Michael Weinstein, President of AIDS Healthcare Foundation. “It is difficult for many of those who are already infected with HIV to properly comply with daily drug regimens. Expecting uninfected people to remember to take a drug every day for a disease that they don’t have is an even more daunting challenge. At least now the ‘black box warning’ label on Truvada for prevention recommends HIV testing every three months. It is good to see that the FDA and Gilead have finally come to this realization. I believe it was in part because of our advocacy over the past year opposing the drug for this use that this warning label is now stronger.”

The FDA Advisory Panel took place in May in Silver Spring, MD, at FDA headquarters. Nearly 30 advocates from AHF and other groups spoke against use of the drug for HIV prevention to the panel, which nevertheless indicated it would give preliminary approval to Gilead for use as HIV prevention.

Later in the summer, at the ‘Controlling the HIV Epidemic with ARVs’Summit, held in London June 11-12, a Gilead official publicly disclosed in a plenary session in which he was participating that use of its blockbuster AIDS treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to prevent possible HIV infection would have labeling indicating that a negative HIV test will be required before a prescription.

Following is what the Truvada packaging and printed drug warning inserts now state regarding use of the drug for pre-exposure prophylaxis (PrEP) for HIV prevention:

For PrEP:

"When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:

• prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [See Warnings and Precautions (5.9)];
• counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [See Warnings and Precautions (5.9)];
• confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. [See Warnings and Precautions (5.9)]; and
• screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP."

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Source

AIDS Protesters Led by AHF Target Gilead’s CEO John Martin over Drug Pricing, Salary at USCA

AIDS advocates from AHF and other groups around the US protest Gilead for its $28K price of the HIV drug, Stribild and CEO John Martin's $54M earnings at the 2012 U.S. Conference on AIDS in Las Vegas. (Photo: Business Wire)

October 03, 2012 10:10 PM Eastern Daylight Time

Advocates target Gilead with three days of protests and actions at United States Conference on AIDS (USCA) over steep price of Gilead’s latest AIDS treatment, Stribild, at $28,000 per patient, per year while CEO John Martin earned $54.5 million in his most recently reported compensation, landing him 10^th on Forbes’ List of highest paid U.S. CEOs

LAS VEGAS--(BUSINESS WIRE)--AIDS protesters and advocates targeted Gilead Sciences and its CEO John Martin with three days of protests and actions at the United Stated Conference on AIDS (USCA) in Las Vegas over the steep pricing of Gilead’s latest AIDS treatment, Stribild—priced at $28,000 per patient, per year in early September after FDA-approval of the drug—which came on the heels of the news that CEO Martin earned $54.5 million in his most recently reported annual compensation from Gilead, an amount that landed him tenth on Forbes’ List of highest paid CEOs in the United States. Martin joined CEOs for Disney, Occidental Petroleum and Starbucks in an elite club of top executive earners.

AIDS Healthcare Foundation (AHF) spearheaded the protests at the conference, which ends today and according to the website of conference host, the National Minority AIDS Council (NMAC), “…is the largest annual AIDS-related gathering in the U.S., bringing together thousands of workers from all fronts of the HIV/AIDS epidemic—from case managers and physicians, to public health workers and advocates, people living with HIV/AIDS (PLWHAs) to policymakers—to build national support networks, exchange the latest information and learn cutting-edge tools to bring an end to the HIV/AIDS epidemic.”

“On Sunday we effectively shut down the Gilead booth that was promoting Stribild when we surrounded it, chanting and doing a ‘die in.’ The response from conference attendees was pretty positive, as many of them photographed the action and took the John Martin $1,000 bills that we handed out. We had some attendees join in our protest holding signs and chanting with us,” said Joey Terrill Director of Community Mobilization for AIDS Healthcare Foundation. “On Monday, we changed our strategy protesting and returning after twenty minutes or so effectively ‘chasing’ playing this ‘cat-and-mouse’ game. We also marched with signs around their other booth, which was not Stribild-specific, spreading out our advocacy action to another central location in the exhibition hall. All this was part of our overall effort to highlight and shame Gilead for the huge wealth that John Martin is accumulating by gouging government programs—the largest purchaser of pharmaceuticals—for their AIDS drug pricing and policies exemplified by the astronomical $28,000 price of Stribild.”

Each day at the protests, AHF’s Terrill dressed as John Martin wearing a mask with his likeness. Terrill was joined by dozens of others from AHF and other AIDS groups around the U.S. at the actions sporting a mix of handwritten signs, banners with the $1,000 John Martin bill and handing out smaller versions of the bill with information about the group’s concerns printed on the back.

“It’s outrageous for Gilead’s CEO to be one of the highest paid executives in the nation, making tens of millions of dollars by selling lifesaving medications at such high prices that more than 2,000 Americans in desperate need of medications cannot access them,” said Michael Weinstein, AHF’s President. “People living with HIV/AIDS, their families, friends and communities should be up in arms over this sort of corporate greed in the face of life-or-death need. So too should taxpayers, who are almost directly responsible for placing wads of cash in Martin’s pockets. It’s the taxpayers who foot the bill for government health care programs—like state AIDS Drug Assistance Programs—a significant contributor to Gilead’s profit margin.”

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 183,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50430476&lang=en

Contacts

AIDS Healthcare Foundation
Ged Kenslea
Communications Director
Los Angeles, CA, USA
+1.323.791.5526 [mobile]
+1.323.308.1833 [work]
gedk@aidshealth.org
or
AIDS Healthcare Foundation
Joey Terrill
Director of Community Mobilization
Washington, DC, USA
+1.213.405-5831 [office]
+1.213.453.3630 [mobile]
timothy.boyd@aidshealth.org

Source

AHF Says DISH-TV Censors TV Ad Targeting Hershey over AIDS Discrimination

PRESS RELEAE

May 1, 2012, 6:06 p.m. EDT

 

DISH-Network refuses to run advocacy ad in L.A. market targeting Hershey Company over its rejection of a 13-year-old boy for enrollment at the Milton Hershey School due to his HIV-positive status; TV network states it has contracts with the agency representing Hershey as well as other networks that Hershey advertises on and it would be a conflict of interest to run an anti--Hershey campaign

LOS ANGELES, May 01, 2012 (BUSINESS WIRE) -- --AIDS advocates will continue to press Hershey Company--which funds the school--to denounce the discrimination and facilitate the boy's enrollment at the school

AIDS Healthcare Foundation (AHF), today criticized the DISH Television Network over its refusal to broadcast a 30 second paid television advertisement in the Los Angeles market that was produced by AHF and targets the Hershey Company over a high profile case of AIDS discrimination at the prestigious, Hershey-funded Milton Hershey School. The television spot, which was to start running on stations on the DISH Network in the Los Angeles market May 1st, was rejected by DISH executives who stated they have contracts with the agency that represents Hershey as well as with other networks that Hershey advertises on and it would be a conflict of interest to run an anti--Hershey campaign.

"We are extremely disappointed that DISH Television censored a paid television advocacy ad in which AHF speaks out against the Hershey Company over HIV/AIDS discrimination at the Hershey School," said Michael Weinstein, President of AIDS Healthcare Foundation. "Technically, as a satellite broadcaster, DISH may have a bit more cover than a traditional broadcaster regarding infringing on our free speech rights under the first amendment; however, it is ironic that we specifically sought to place this spot through DISH on stations like MSNBC, which are filled with policy programs and serious talk shows whose bread and butter is lively debate and discussion about many controversial issues and topics. We think it is cowardly of DISH to block our message as they have."

In rejecting the spot, DISH officials also noted that they would have to apply a 'Controversial Issues' filter to the TV spot, a move which would block it from almost every network they air, based on the restriction documents DISH receives from the programmers. DISH officials also added that even on the networks that technically allow this type of content, they would risk receiving subscriber complaints.

Background on Hershey School AIDS Discrimination

The Milton Hershey School--a boarding school for low-income students funded by the Hershey Company--recently rejected the boy for admission citing his HIV-positive status as the reason, misguidedly calling him a "direct threat to the health and safety of others." AHF has also launched a website www.EndHIVStigma.org where the public can learn more about the case, learn the facts about HIV/AIDS and send e-letters to three Hershey Company board members who also sit on the board of the Milton Hershey School Trust, urging them to denounce the discrimination and facilitate the boy's admission into the school.

According to the Associated Press (claim:Hershey School Rejects HIV-Positive Pa. Boy)(claim:By Peter Jackson)(claim:12/1/11): "A private boarding school connected with the Hershey chocolate company says it was trying to protect other students when it denied admission to a Philadelphia-area teenager because he is HIV-positive. The AIDS Law Project of Pennsylvania filed a lawsuit on behalf of the unidentified boy in U.S. District Court in Philadelphia on Wednesday, claiming the Milton Hershey School for disadvantaged students violated the Americans with Disabilities Act. School officials acknowledged that the 13-year-old boy was denied admission because of his medical condition. They said they believed it was necessary to protect the health and safety of the 1,850 others enrolled in the residential institution, which serves children in pre-kindergarten to 12th grade and where students live in homes with 10 to 12 others."

Ryan White was an American teenager from Kokomo, Indiana who, in the mid-1980s, was expelled from middle school because he was HIV-positive. A lengthy legal battle with the school ensued and White became a galvanizing force in educating the country about HIV & AIDS at a time when misinformation about the disease was widespread. After his death in 1990, the U.S. Congress passed a major piece of legislation named in his honor, the Ryan White CARE Act, which provides funding for HIV/AIDS programs for low-income American.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 166,000 individuals in 25 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. www.aidshealth.org

SOURCE: AIDS Healthcare Foundation

Source

AHF Asks 'What's Rotten at FDA?' in New Politico Playbook Ads

PRESS RELEASE

March 13, 2012, 6:00 a.m. EDT

According to AHF, the FDA spied on its own scientists and doctors, shows little or no transparency and granted fast track review to Gilead Sciences for its application for use of its blockbuster AIDS treatment, Truvada, as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application

WASHINGTON, Mar 13, 2012 (BUSINESS WIRE) -- --In response, AHF expands advocacy campaign targeting the FDA and Gilead with a new online banner ad asking, "What's Rotten at FDA?" on the Politico.com website and Mike Allen's Politico Playbook; public is invited to send e-letters to HHS Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA

As part of its ongoing effort to ensure that the Food and Drug Administration (FDA) does not hastily approve Gilead Sciences' controversial application for expanded use of its blockbuster AIDS treatment, Truvada, as a form of HIV prevention in uninfected individuals, AIDS Healthcare Foundation (AHF) this week expanded its media and advocacy campaign targeting the two parties with a series of pointed online text and banner ads on Mike Allen's Politico Playbook on Politico.com asking, "What's rotten at FDA?" The banner ad runs in the online version of Politico Playbook March 12 through March 16. In addition, text ads embedded into Allen's editorial content will run each of those days. The 'What's rotten...' banner ad directs people to a website where the public may send e-letters to H.H.S. Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA.

"In January, the FDA was sued for spying on its own scientists and doctors. In February, it announced it was fast tracking consideration of expanded use of Gilead's AIDS treatment, Truvada, as a possible HIV prevention pill drug despite numerous failed clinical trials for that purpose. Overall, it has shown little or no transparency in its dealing with the public--this, in a presidential administration that has vowed to be the most transparent in history," said Michael Weinstein, President of AIDS Healthcare Foundation. "Something is certainly rotten at the FDA and through these ads and this campaign, we hope to shine a bright light on it."

On December 15, 2011, Gilead issued a press release formally announcing that it had filed an FDA application to expand use of Truvada as a form of HIV prevention; however, no date of the application was included in Gilead's statement. On February 13, 2012, Gilead announced that FDA had granted its fast track application for consideration of Truvada as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application.

AHF's What's rotten at FDA? Advocacy advertisements on Mike Allen's Politico Playbook, March 12-16

Text of Ad #1 What's Rotten at FDA? ** A message from AIDS Healthcare Foundation: What's rotten at FDA? The U.S. Food & Drug Administration refuses to release documents regarding contact with drug company Gilead Sciences about the drug Truvada for HIV prevention. The FDA is now hastily considering approving this drug despite several failed clinical trials. More info at www.nomagicpills.org . **

53 words

** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about safety and effectiveness. Current studies show that patients failed to take the drug (Gilead Sciences' Truvada) daily, a precondition for effectiveness. There is also a significant risk that the people who take it haphazardly will mistakenly believe they are protected from HIV and other STDs and behave recklessly, increasing the number of new infections. The agency has refused to release documents regarding its contact with Gilead. What do they have to hide?

The mismanagement at FDA reaches beyond HIV. The Washington Post reported that the agency's own scientists are suing because the FDA secretly monitored the personal e-mail of a group of internal "whistle-blowers." Clearly, the FDA can no longer fulfill its mission to protect the public health.

What is rotten at FDA? More info at www.nomagicpills.org . **

154 words

Text of Ad #2 What's Rotten at FDA?--No Transparency ** A message from AIDS Healthcare Foundation: AIDS advocates and doctors warn that FDA's hasty review of Gilead's Truvada for HIV prevention threatens the safety of the American public. The FDA is ignoring this warning, claiming that its drug review process "is not a participatory process," and the "premise that FDA's review of a pending drug application should be transparent is also wrong." More info at www.nomagicpills.org .

67 words

** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about its safety and effectiveness. AIDS advocates and the medical community have loudly warned that this drug (Gilead Sciences' Truvada) has failed to prevent HIV in multiple clinical trials, and carries an increased risk of kidney damage for people who take it.

In response to these concerns and calls for greater transparency at FDA, the agency says that its drug review process "is not a participatory process," and that the "premise that FDA's review of a pending drug application should be transparent is also wrong." FDA has also refused to release documents regarding its close contact with Gilead. What do they have to hide?

More info at www.nomagicpills.org .

135 words

Text of Ad #3 What's Rotten at FDA?--Spying ** A message from AIDS Healthcare Foundation: What's rotten at FDA? Spying. The 'Washington Post' reported the FDA secretly monitored personal e-mail accounts of some of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients. More info at www.nomagicpills.org .

49 words

** A message from AIDS Healthcare Foundation: The Post said the surveillance, unearthed by six of the scientists and doctors, who then filed a federal lawsuit against the FDA, took place over two years as the group accessed their personal G-mail accounts from government computers. This behavior took place at the highest levels of the FDA during the Obama administration--which vowed to be the 'most transparent' in history. Now, FDA is considering fast track approval an HIV prevention drug despite serious concerns about its safety and effectiveness, which might actually result in MORE HIV infections. Why? People may think they are fully protected when they are not, and may not use condoms, a proven HIV prevention method 95% effective when used correctly and consistently. Something is rotten at FDA--jeopardizing the health and safety of the American people--the very people FDA is charged with protecting. More info at www.nomagicpills.org .

150 words

Background on Gilead and the FDA

Gilead is seeking FDA approval to market the AIDS drug, Truvada, as a means of Pre-Exposure Prophylaxis, or PrEP. The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS. While early studies saw some initial potential, more recent studies have been halted because the drug has shown little or no preventative effect. In addition, a study released this month found that people who take Truvada are at higher risk for kidney disease and long-term kidney damage that persists even after they stop taking the drug.

AHF strongly opposes Gilead's application because the science does not yet demonstrate that Truvada for HIV prevention is safe or effective. While some studies claim to show a limited preventive effect (only 44%), other studies have been halted because PrEP was not shown to be any more effective than a placebo. A primary reason for these poor results is the failure of study participants to take the drug daily, a precondition for PrEP to have any preventive effect. When this occurs in a "real world" setting, people will not only be at higher risk for developing drug resistance, but we will see an increase in HIV infections.

The alleged mismanagement at FDA reaches beyond HIV. In January, the Washington Post reported that the agency's own scientists are suing the agency because "the [FDA] secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients." Clearly, the FDA can no longer fulfill its mission to protect the public health by ensuring that our food, drugs and medical equipment are safe and do not cause harm to the public.

For more information, please visit www.nomagicpills.org .

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 135,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare

SOURCE: AIDS Healthcare Foundation

Source

A Dose Of Caution : Petition Filed To Block HIV Prevention Pill

Mar 8, 2012 | 12:41PM

(RTTNews.com) - There has been much debate regarding Truvada ever since Gilead Sciences Inc. (GILD) sought regulatory approval to market its HIV treatment medication Truvada as a HIV prevention pill. Some public health advocates are concerned about Gilead's move as they fear that the expanded use of the drug would lead to individuals engaging in unprotected sex, and would, in fact, increase the incidence of HIV and other infections.

Truvada, a combination of Gilead's two drugs - Viread and Emtriva, received an accelerated approval from the FDA in August 2004, followed by traditional approval in March 2006, for the treatment of HIV in combination with other antiretroviral drugs.

Last December, Gilead filed a supplemental New Drug Application with the FDA seeking approval of its once-daily Truvada for HIV prevention. This prevention approach is known as pre-exposure prophylaxis or PrEP. The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS.

The sNDA application was based on two large phase III trials known as Pre-Exposure Prophylaxis Initiative, or iPrEx, and Partners PrEP.

In the iPrEx study, which involved 2,499 high-risk HIV-negative homosexuals in the US and other countries, the once daily use of Truvada reduced the risk of acquiring HIV by 44 percent compared with placebo and by up to 73 percent in men who took the drug consistently. In men with enough detectable drug presence, the risk was reduced by more than 90 percent.

In the other trial, Partners PrEP, which involved 4,758 heterosexual couples in Kenya and Uganda in which only one partner was infected with HIV, once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 percent compared with placebo.

Despite the impressive results, experts remain wary about expanding the use of antiretrovirals to include HIV prevention.

An article that appeared in The Lancet, a British medical journal, last year, cautions that "pre-exposure prophylaxis is unlikely to be 100%, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected".

On March 1st, two UK organizations, the British HIV Association and the British Association for Sexual Health and HIV issued a statement stating that the existing data on the efficacy of pre-exposure prophylaxis is not compelling enough for it to be offered to patients on demand, and therefore needs more study.

In light of experts voicing concern over the new pharmaceutical prevention approach to HIV, AIDS Healthcare Foundation, the largest global AIDS organization, is gearing up to block the regulatory approval of Gilead's AIDS treatment, Truvada, for expanded use as a method of preventing HIV infection in non-infected people.

The AIDS Healthcare Foundation, or AHF, filed a citizen's petition on March 7 asking the FDA not to approve the pending sNDA submitted by Gilead, which seeks permission to market once-daily Truvada for pre-exposure prophylaxis to reduce the risk of HIV transmission in uninfected adults.

Under law, the FDA has 180 days to respond to AHF's complaint. However, the FDA can approve Gilead's supplemental New Drug Application for expanded use of Truvada during that same time window.

The supplemental New Drug Application for Truvada, which has been granted a six-month Priority Review, has a decision date set for June 15, 2012. The application of Truvada for PrEP is also expected to be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May.

According to the AHF, the prevention approach to HIV, will not work on a large-scale basis because, "consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed. Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection".

A new analysis by UCSF (University of California at San Francisco) researchers, published last month in the journal AIDS, reveals that Tenofovir - the active ingredient in Viread, ( one of the two drugs that make up Truvada) is associated with an increased risk for kidney disease and damage that increases over time and doesn't appear to be reversible.

According to Michael Weinstein, AHF's president, it is sheer corporate greed that is behind the idea of giving healthy people a toxic drug that will damage their kidneys in order to possibly prevent HIV - when a simple condom use is 95% effective.

Truvada, Gilead's second-best selling product, generated sales of $2.88 billion in 2011 compared to $2.65 billion in 2010. If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV.

The first mention of the HIV virus was made in a report by the Centers for Disease Control and Prevention, or CDC, on June 5, 1981, which marked the official beginning of the HIV/AIDS epidemic. It is estimated that over 33 million people are living with HIV worldwide and 28 million have died from an AIDS-related illness since 1981, mostly in Africa.

There has been a tremendous progress in the treatment of HIV/AIDS since the introduction of antiretroviral therapy in 1996. Advancing to HIV prevention from HIV treatment may mark the beginning of the end of AIDS.

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