AT SIGNING OF THE RYAN WHITE HIV/AIDS

TREATMENT EXTENSION ACT OF 2009

Diplomatic Reception Room

11:58 A.M. EDT

THE PRESIDENT:  Good morning, everybody.

AUDIENCE:  Good morning.

THE PRESIDENT:  We often speak about AIDS as if it’s going on somewhere else.  And for good reason — this is a virus that has touched lives and decimated communities around the world, particularly in Africa.  But often overlooked is the fact that we face a serious HIV/AIDS epidemic of our own — right here in Washington, D.C., and right here in the United States of America.  And today, we are taking two important steps forward in the fight that we face here at home.

It has been nearly three decades since this virus first became known.  But for years, we refused to recognize it for what it was.  It was coined a “gay disease.”  Those who had it were viewed with suspicion.  There was a sense among some that people afflicted by AIDS somehow deserved their fate and that it was acceptable for our nation to look the other way.

A number of events and advances over the years have broadened our understanding of this cruel illness.  One of them came in 1984, when a 13-year-old boy from central Indiana contracted HIV/AIDS from a transfusion.  Doctors assured people that Ryan White posed no risk to his classmates or his community.  But ignorance was still widespread.  People didn’t yet understand or believe that the virus couldn’t be spread by casual contact.  Parents protested Ryan’s attendance in class.  Some even pulled their kids out of school.  Things got so bad that the White family had to ultimately move to another town.

It would have been easy for Ryan and his family to stay quiet and to fight the illness in private.  But what Ryan showed was the same courage and strength that so many HIV-positive activists have shown over the years and shown around — show around the world today.  And because he did, we didn’t just become more informed about HIV/AIDS, we began to take action to fight it.

In 1990, the year Ryan passed away, two great friends and unlikely political allies, Ted Kennedy and Orrin Hatch, came together and introduced the Comprehensive AIDS Resources Emergency Act — the CARE Act — which was later named after Ryan.

In a few minutes, I’m going to sign the fourth reauthorization of the Ryan White CARE Act.  Now, in the past, policy differences have made reauthorizations of this program divisive and controversial.  But that didn’t happen this year.  And for that, the members of Congress that are here today deserve extraordinary credit for passing this bill in the bipartisan manner that it deserves:  Tom Harkin and Mike Enzi in the Senate, we are grateful to you for your extraordinary work; Speaker Pelosi, who’s always leading the charge on so many issues; Frank Pallone, Jr., Joe Barton, Barbara Lee and Donna Christensen in the House, thank you for your extraordinary work — oh don’t worry, I’m getting to Henry.  (Laughter.)  Nancy is always looking out for members, but we’ve got a special section for Henry.

And Chairman Henry Waxman, who began holding hearings on AIDS in 1982, before there was even a name for AIDS, was leading here in Washington to make sure that this got the informed attention that it deserved and who led the House in passing the original Ryan White legislation in 1990.

I also want to acknowledge the HIV community for crafting a consensus document that did so much to help move this process forward.  Some of the advocates so important to this legislation are with us here today:  Ernest Hopkins from Cities Advocating for Emergency AIDS Relief; Frank Oldham, Jr., President and CEO of the National Association of People with AIDS; and Julie Scofield, Executive Director of the National Alliance of State and Territorial AIDS Directors.

And I’m especially honored that Ryan’s mother, Jeanne White-Ginder, is here today.  For 25 years, Jeanne had an immeasurable impact in helping ramp up America’s response to this epidemic.  While we lost Ryan at too young an age, Jeanne’s efforts have extended the lives and saved the lives of so many others.  We are so appreciative to you.  Thank you.  (Applause.)

You know, over the past 19 years this legislation has evolved from an emergency response into a comprehensive national program for the care and support of Americans living with HIV/AIDS.  It helps communities that are most severely affected by this epidemic and often least served by our health care system, including minority communities, the LGBT community, rural communities, and the homeless.  It’s often the only option for the uninsured and the underinsured.  And it provides life-saving medical services to more than half a million Americans every year, in every corner of the country.

It’s helped us to open a critical front on the ongoing battle against HIV/AIDS.  But let me be clear:  This is a battle that’s far from over, and it’s a battle that all of us need to do our part to join.  AIDS may no longer be the leading killer of Americans ages 25 to 44, as it once was.  But there are still 1.1 million people living with HIV/AIDS in the United States, and more than 56,000 new infections occur every single year.

Some communities still experience unacceptably high rates of infection.  Gay men make up 2 or 3 percent of the population, but more than half of all new cases.  African Americans make up roughly half of all new cases.  Nearly half of all new cases now occur in the South.  And a staggering 7 percent of Washington, D.C.’s residents between the ages of 40 and 49 live with HIV/AIDS — and the epidemic here isn’t as severe as it is in several other U.S. cities.

So tackling this epidemic will take far more aggressive approaches than we’ve seen in the past — not only from our federal government, but also state and local governments, from local community organizations, and from places of worship.

But it will also take an effort to end the stigma that has stopped people from getting tested; that has stopped people from facing their own illness; and that has sped the spread of this disease for far too long.  A couple of years ago Michelle and I were in Africa and we tried to combat the stigma when we were in Kenya by taking a public HIV/AIDS test.  And I’m proud to announce today we’re about to take another step towards ending that stigma.

Twenty-two years ago, in a decision rooted in fear rather than fact, the United States instituted a travel ban on entry into the country for people living with HIV/AIDS.  Now, we talk about reducing the stigma of this disease — yet we’ve treated a visitor living with it as a threat.  We lead the world when it comes to helping stem the AIDS pandemic — yet we are one of only a dozen countries that still bar people from HIV from entering our own country.

If we want to be the global leader in combating HIV/AIDS, we need to act like it.  And that’s why, on Monday my administration will publish a final rule that eliminates the travel ban effective just after the New Year.  Congress and President Bush began this process last year, and they ought to be commended for it.  We are finishing the job.  It’s a step that will encourage people to get tested and get treatment, it’s a step that will keep families together, and it’s a step that will save lives.  (Applause.)

We are continuing the work of crafting a coordinated, measurable national HIV/AIDS strategy to stem and suppress this epidemic.  I’m pleased to report that the Office of National AIDS Policy, led by Jeffrey Crowley, has already held eight in a series of 14 community discussions in cities across the country.  They’ve brought together faith-based organizations and businesses, schools and research institutions, people living with HIV and concerned citizens, gathering ideas on how to target a national response that effectively reduces HIV infections, improves access to treatment, and eliminates health disparities.  And we are encouraged by the energy, the enthusiasm, and great ideas that we’ve collected so far.

We can’t give Ryan White back to Jeanne, back to his mom.  But what we can do — what the legislation that I’m about to sign has done for nearly 20 years — is honor the courage that he and his family showed.  What we can do is to take more action and educate more people.  What we can do is keep fighting each and every day until we eliminate this disease from the face of the Earth.

So with that, let me sign this bill.  (Applause.)

The legislation provides care, treatment and support services to nearly half a million people, most of whom are low-income.

Obama also announced that the Department of Health and Human services has finally crafted a new regulation spelling the  end to the HIV Travel and Immigration Ban. The regulation goes into effect in January.

“We often speak as if AIDS is going on somewhere else. Often overlooked is that we face a serious HIV/AIDS epidemic of our own,” Obama said prior to the signing. He noted that early on, AIDS was considered a “gay disease, and those who had it were viewed with suspicion.”

This is the fourth re-authorization of the Ryan White bill, and Obama said it was the first time that the bill was not controversial or divisive, and passed with bi-partisian support.

There are 1.1 million living with HIV/AIDs in the United States; more than 56,000 cases are added each year. Obama noted that gay men, though they comprise 2 to 3 percent of the population, make up about half of all new cases, and that African-Americans make up almost half.

Obama said he hoped the lifting of the travel ban would help end the stigma attached to HIV/AIDS. He also said that he and his wife Michelle would be getting a second AIDS test soon.

For 22 years, United States had one of the most restrictive policies on the immigration and travel of HIV-positive people in the world. According to a historian writing for SHAFR.org:

“It compelled all non-citizens to attest that they were HIV-negative before being admitted to the United States for any reason – despite the obvious impossibility of enforcing this provision. At the same time, non-citizens living long-term in the United States were denied permanent resident categorization solely on basis of their HIV-positive status. While invoking its sovereign rights to control immigration and tourism, the U.S. government clung to policies suffused with the ignorance and bias toward HIV-positive people illustrated at the earliest stages of the AIDS pandemic.

“It disregarded the fact that for almost 25 years, it has been common medical knowledge that one cannot contract or transmit HIV casually. AIDS activists asserted that the HIV bar dissuaded immigrants unsure of their HIV status from getting tested; prompted HIV-positive immigrants not to seek to medical treatment until they had full-blown AIDS; and caused HIV-positive people seeking visas to lie on their applications and then enter the U.S. without their medications – situations posing exactly the threats to public health the 1987 ban aimed to prevent.”

In July 2008 as part of an AIDS bill,  Congress voted to restore the authority of the Secretary of Health and Human Services to remove HIV from the immigration and visitor ban list. George W. Bush signed it into law – but HHS had not yet issued a revised rule until today, which meant that those with HIV and AIDS were still banned from the country.

When it comes to HIV, AIDS, and communities of color the news is always bleak. To break that cycle a new study, focusing in the Bronx and Washington, DC, will attempt to test and treat every adult.

Surprisingly, or not, this new study isn’t about slowing the virus. Instead the survey will examine  if a test and treat program can be carried out here—testing and treating is much more common in the developing world.

One of the reasons why this is being considered is because in some communities people fall through the cracks when it comes to HIV treatment, whether it’s getting tested or getting connected with drugs if needed. Apparently in DC in 2006, about half of residents with a recent HIV diagnosis sought out a physician about it within six months. In New York City, the Bronx has the highest rate of AIDS deaths, even though Manhattan has a larger rate of cases. This discrepancy is due to a delay in treatment.

There are multiple reasons why people wait to seek out medical care. Fear. Concern of what families and friends will say. A stubborn trend to be dismissive of traditional medicine. A sense that HIV and AIDS is a disease of the other. I still marvel at talking to a preacher, about 9 years back, who went into the history of AIDS. According to his rendering  AIDS was created in a federal lab, spread to gay men as a way to rid the world of homosexuality.

“Thank goodness the virus hasn’t hit the black community yet,” he said.

Hopefully that man of faith joined the reality based world, but as the numbers show too many are not there yet.

Yet, the findings are exciting to scientists, who think they may show how to make a better vaccine.

The results also hint that the vaccine may work better in the general population than in those at higher risk of infection, such as gay men and intravenous drug users. It was the first time an AIDS vaccine was tested mostly in heterosexuals at average risk, and doctors have long known that how a person is exposed to HIV affects the odds of becoming infected.

“This study becomes a landmark. You can put it on a map and begin to figure out where you go from here,” said Col. Jerome Kim, the U.S. Army doctor who co-led the trial.

Last month, researchers announced that a two-vaccine combination cut the risk of becoming infected with HIV by more than 31 percent in a trial of more than 16,000 volunteers in Thailand.

Full results, published online Tuesday by the New England Journal of Medicine and presented at a scientific conference in Paris, include two additional analyses that merely suggest the vaccine is beneficial, rather than providing definitive proof.

That’s mostly because so few participants became infected – only 125 people, 10 times less than in previous HIV vaccine trials, said Dr. Anthony Fauci, director the National Institute of Allergy and Infectious Diseases, the study’s main sponsor.

Critics had leaked one of the analyses last week, saying it showed the original results may have been a fluke. A California-based AIDS advocacy group criticized study leaders for not giving a fuller picture when they held their news conference last month.

“The bottom line is that those results are real,” even though they are not good enough to justify using this vaccine now, said Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, an alliance of governments, AIDS scientists, the World Health Organization and funders such as the Bill & Melinda Gates Foundation.

“We, for the first time, have evidence of protection, and the nitty gritty (arguments) to me don’t matter a damn,” Bernstein said.

Other scientists who, like Bernstein, had no role in the trial, agreed.

“It’s a consistent story. There seems to be some effect. And I think it is an important study. It redirects the field to look at a different kind of vaccine and different kinds of immune responses” than what have been the focus in the past, said Dr. Lawrence Corey of the University of Washington. He heads the HIV Vaccine Trials Network, an international group of scientists who test vaccines.

The Thailand Ministry of Public Health conducted this trial, which used vaccines made from strains of HIV common in Thailand. They are ALVAC, made by Sanofi Pasteur, and AIDSVAX, originally developed by VaxGen Inc. and now held by the nonprofit Global Solutions for Infectious Diseases. The vaccines are not made from whole virus and cannot cause HIV infection.

The combo was tested in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four doses of ALVAC and two of AIDSVAX over six months; the rest received dummy shots. All were given condoms and counseling, and were followed for three years after vaccination ended.

New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group.

In a smaller analysis of just the 12,452 participants who received all six shots exactly on schedule, there were 86 infections – 36 in the vaccine group and 50 in those given dummy shots.

The vaccine appeared nearly twice as effective among those at low or moderate risk for HIV, versus people who share needles, have contact with prostitutes or engage in other risky behaviors. But those results were not statistically significant, meaning they could have occurred by chance.

“Perhaps the requirements for protection against transmission in low-risk heterosexual persons are considerably different or less stringent,” Dr. Raphael Dolin of Beth Israel Deaconess Medical Center in Boston wrote in an editorial published by the medical journal.

Evidence of vaccine protection emerged at six months to one year and then seemed to wane, although this trend, too, was not statistically significant.

“It would suggest the vaccine is not that potent,” although there were too few infections in either group to make solid comparisons, said Dr. Seth Berkley, president of the International AIDS Vaccine Initiative, which helps develop and assess potential vaccines.

The U.S. Army has long had a partnership with Thailand and its Royal Army to test vaccines and medicines to protect troops and the general population. Soaring rates of HIV infection a decade ago led the Thai government to make vaccine research a high priority. Some previous experimental AIDS vaccines have been tested in Thailand as well.

He was born in 1945 in Massachusetts. He came out publicly as gay in his late twenties.

Monette received his B.A. from Yale in 1967 and dedicated himself to the writing of poetry for eight years.

He turned to fiction writing in the late 1970s and early 1980s, publishing four successful novels between 1978 and 1982.

Monette suffered a personal setback when his long-time partner, Roger Horowitz, was diagnosed with HIV/AIDS in the early 1980s.

Horowitz died of AIDS in 1986. Monette published two memoirs in 1988 that dealt with the battle he and his partner went through after the latter was diagnosed with HIV/AIDS.

Monette returned to fiction in the early 1990s with the publication of two novels about AIDS.

He died in 1995 of AIDS-related complications. He was 49.

The Food and Drug Administration’s panel of virus experts voted 10-4 in favor of the new use, despite some inconsistency in company studies of the drug. Selzentry is approved as a secondary option for HIV patients who are not responding to other antiviral drugs. New York-based Pfizer is asking the FDA to approve the drug as an initial treatment.

Pfizer’s initial study comparing Selzentry with Bristol-Myers Squibb’s Sustiva failed to meet the goal of showing it was at least as effective at suppressing HIV.

But when Pfizer reanalyzed the results using a different test to screen patients, the study met its goal.

FDA reviewers raised concerns about higher levels of viral activity in patients taking Selzentry compared with Sustiva. About 32 percent of patients did not adequately respond to Pfizer’s drug, compared with 24 percent of patients taking the alternative.

A majority of panelists ultimately said the drug works and should be made available as an option for patients, though they expressed lingering concerns about the strength of its effect.

“It’s clearly an active drug, it demonstrated effectiveness,” said Dr. Russell Van Dyke, of the Tulane University School of Medicine. “But I’m worried it’s not as potent as we might like.”

Other panelists said they were not comfortable backing a product that could be inferior to drugs already on the market.

“There’s a lot that’s promising about this drug, but this trial doesn’t convince me,” said Dr. Barbara McGovern, of Tufts University Medical School.

Panelists said Pfizer should continue collecting data on the drug’s effectiveness, particularly in minority populations.

The FDA is not required to follow the advice of its panels, though it usually does.

Selzentry is part of a recently developed class of treatments that block HIV from entering white blood cells through a pathway present in some patients. While more than 1 million people in the U.S. are HIV positive, only a subset of that group respond to Pfizer’s pill. The drug works by blocking the so-called CCR5 receptor.

HIV attacks the body’s immune system, eventually causing AIDS.

Pfizer said the meeting “marks an important step in expanding available treatment options for patients with HIV infection.”

Selzentry had sales of $46 million last year, according to Pfizer.

Quinn introduced a formal resolution with council member Rosie Mendez asking the state legislature to pass the bill, which is currently languishing in committee in the Assembly. Earlier this year, the Senate version passed, sheperded by openly gay Sen. Tom Duane.

The  legislation proposes that NYC residents who are clients under HIV/AIDS Services Administration (HASA) will pay no more than 30 percent of their income towards rent.

Quinn said the bill would prevent  11,000 New Yorkers from losing their homes.

“This piece of legislation will not only save money for our state, but it will save
money for the thousands of HASA clients and provide some vital relief for their pocketbooks,” Quinn said. ” I urge Speaker Sheldon Silver and Governor David Paterson to support this bill so we can take action towards making HASA clients’ lives easier and more affordable.”

The City Council resolution passed; the Assembly has yet to take action.