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Remarks for World AIDS Day

Remarks as Delivered by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
White Oak Campus, Silver Spring, Maryland
December 1, 2011

I want to thank all of you for joining us today for this World AIDS Day event: “Looking Backward-Forging Forward.”  I also want to thank you for joining us to remember all those who have lost the battle against AIDS…all those who are still struggling with the disease…and all those patients who may be facing prejudice and discrimination.

As many of you are aware, the international theme for this year’s World AIDS Day is:  "Getting to Zero: Zero New HIV Infections.  Zero Discrimination.  Zero AIDS-Related Deaths.” 

Twenty-five years ago, it would have seemed improbable, if not impossible, to envision a time when we could discuss getting to “zero”…when we could imagine the day when AIDS would no longer be a death sentence, but a chronic, yet manageable, disease.

So despite all the work we have ahead of us, and the real crisis that still exists in many parts of the world, we should be proud of how far we have come.

Today’s event is an appropriate recognition of the extraordinary progress made…and an important reminder that the most profound challenge still remains before us:  to end this devastating epidemic…to truly get to zero.

As some of you know, this was the disease that redefined my career and redirected me to public service. When I was a medical student, I was part of the generation that was being told that we were on the threshold of removing infectious disease from the headlines and consigning them to the history books.   

Then the AIDS epidemic began.  I remember seeing these strange cases of immune deficiency, mainly in previously healthy young men.  No one knew where it came from.  No one knew what caused it.  And no one knew how to cure it…or even what to call it. 

By the time I did my residency in New York City, I was taking care of many AIDS patients. But there was nothing we could give them. Patients were wasting away before our eyes, but there were no drugs available…only supportive care.  We had no effective treatments…no medicine or miracle on the horizon. It was an extremely difficult time for those who contracted HIV.

Soon after, I went to work for Dr. Tony Fauci at the National Institute of Allergy and Infectious Diseases. And at that point in the AIDS epidemic—back in the late 1980s—candidate drugs were just emerging. The great push was getting as many people as possible into clinical trials, so they’d have at least some chance for treatment.

It’s interesting that some advocates and others questioned why these clinical trials had to happen at all. They reasoned that patients facing death should have the chance to take anything that might bring them benefit. Not surprisingly, it turned out that some of those medications worked and others did not.  And since then, knowing which medications are effective has extended the lives of millions of patients in the United States and around the world.

It was these experiences that helped me decide to put aside my dreams of academic medicine…and to instead pursue a career in public health.  And in almost three decades, I’ve never looked back. 
For thirty years, the FDA has also never looked back on its efforts to ease the suffering and extend the lives of AIDS patients—while also working for a cure.

Since approval of the first AZT in 1987, we now have 33 HIV/AIDS drugs in seven different classes. After decades of research, we have proof of concept for next-generation ARV-based microbicides, which could transform global response to HIV.  We have new strategies for prevention.  And we have more hope than ever that we might find the path to a cure.

But what is remarkable is not just that the FDA has been involved since the very start of the epidemic—it’s that the FDA has also been profoundly changed by it.
We’ve seen incredible examples of systemic change: patient-driven clinical trials…a more collaborative regulatory paradigm for drug approval…and innovative models for HIV education.

Additionally, the FDA established the AIDS Health Fraud Task Force to help educate patients about treatment options…the Division of Antiviral Drug Products to help bring new treatments for HIV to market…and the Office of AIDS and Special Health Issues to coordinate HIV/AIDS related activities within the agency, and to liaison with a broad spectrum of AIDS patients and patient advocates.

In fact, AIDS activists ushered in a new era of patient action, impact, and involvement at the FDA. Those advocates were able to challenge researchers and regulators in science and drug development to think in new and novel ways.

They were the first to sit at the table at FDA advisory committee meetings.  And, for the first time, they brought the unique perspective of the patient to our discussions.

Today, thanks to those early activists and advocates, patient involvement is routine, and the FDA incorporates patients on advisory committees for nearly all serious and life-threatening diseases.

These were all great steps…but they are steps to build on, not to rest on.  As we “look back” on our activities, we must also “forge forward” in our efforts…because there is still so much left to do. 

We still need a vaccine. We need better preventive strategies. We need Phase II trials and beyond for the new microbicides. We need to deepen our understanding of the pathogenesis of disease and the human response. We need more awareness, so that we can bring down rates of new infection. We need to better understand and address the impact of prolonged treatment—such as antibiotic resistance and adverse side effects. And we need a cure.

Of course, if we really want to do all of this, then there is one more thing we need: New and better tools—and we need them now.

As a nation, we are spending billions on scientific research that could, if harnessed, transform and enhance our mission of public health—including the fight against AIDS.  But all of us here know that we’re not even close to fully translating new discoveries and emerging opportunities into products for people who need them.

That’s why we also need to invest in regulatory science…the science that underlies our ability to gather and evaluate the data required to make the best possible—and most efficient—regulatory decisions

In fact, it was earlier investments in regulatory science that enabled FDA to say that surrogate markers could be used in clinical trials in the first place.  And that led to the approval of some of the earliest ARVs.

Of course, in all of our AIDS’ work, it’s important for us to recognize that this is a dynamic process—a continuing process—which builds on what we’ve done over the past thirty years…and which can’t stop until we “get to zero.”

Thanks to so much that’s been done by the FDA—and the concerted efforts of many of you—if the day when we may be able to consign AIDS to the history books is not in sight—it’s certainly in reach. 

We’ve come a long way together since the AIDS epidemic first emerged when I was a medical student.  And here at the FDA, we continue to forge ahead to help write the final chapter on this disease.