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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Launch of the Critical Path to TB Drug Regimens (CPTR) Initiative

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
The National Press Club
Washington, D.C.
March 18, 2010

Good afternoon—and thank you, Dr. [Mel] Spigelman, for your generous introduction.

Part of my role as Commissioner is to speak often—several times a week, usually (today unfortunately it is four times in a day) —to all sorts of groups all over the country. But it is rare that I get the chance to participate in an event that carries such personal meaning for me. I thank you all for the opportunity to be here today.

But the truth is I wish we didn’t have to be here. We are here because every year, nearly 2 million people worldwide die of a disease we learned to cure half a century ago. We are here because many of today’s patients have developed resistance to those decades-old drugs, and these new strains pose a threat to us all. We are here because the science of this disease has been stagnant for too many years—and we still use a primitive diagnostic and a dizzyingly complex regimen that makes treatment and compliance difficult.

Very early in my tenure as New York City Health Commissioner in the early 1990s, I was grappling with an epidemic of resurgent TB. As I strove to get quickly up to speed on the issues, I remember talking to a TB researcher who wistfully observed to me that TB was probably the only field in modern medicine in which he could have gone into hibernation for decades—decades—and woken up to find that almost nothing has changed. His words were true then. And they remain more than a little too true today.

I was appointed Commissioner in New York in 1991. That year marked the highest reported TB case rate in almost three decades. The nearly 4000 cases that were reported that year represented a 152% increase over 1980. It was not an easy year to assume office.

The number of TB cases had been mounting throughout the 1980s—fueled by poverty, homelessness, AIDS, and the erosion of the public health infrastructure. Even then, as you know, the disease was controllable and treatable. Yet it managed to reach epidemic proportions, this time in resistant forms that were harder to treat and cure effectively.

We quickly mobilized to put together a comprehensive approach, investing significant energy and resources to assure appropriate treatment, including the implementation of DOTS—increasing the number of patients receiving directly observed therapy from 100 in 1988 to 1300 in 1993—and increased screening, monitoring, and isolation capacity in hospitals, shelters, and other congregate facilities.

Eventually, thanks to a well-designed program, adequate resources, and real political and program commitment from the Mayor and others, we were able to turn the epidemic around in New York City. Between 1992 and 1997, the number of TB cases in the city dropped by almost 46%, and for the most drug-resistant cases the drop was 86%. Even we were surprised by how much our efforts mattered. It was quite an accomplishment, and I am still proud of how the Department of Health and the city of New York responded to the epidemic.

We were fortunate, and it shows what can be done. And while the situation overall has very significantly improved here in the United States, the global tuberculosis crisis today is far from resolved. The fact is that we are still not harnessing all that science and technology have to offer. The state of TB is already devastating and getting worse—and millions in the developing world are paying most dearly. And it is now more important than ever that policy makers—and the public—really understand what’s at stake here so that the urgency of taking meaningful action can be sustained.

The real reason we’re here today is because everyone in this room is dedicated to fighting this disease.

We all agree: we need better, more effective treatments—innovative combination therapies with shorter-duration regimens that are not just effective but manageable for patients around the world. And to do this quickly, we must simultaneously develop new regulatory processes that test drugs together in combination earlier on—so that these solutions are not dozens of years away, but only a few.

So it is time for us to emerge from hibernation—to advance TB innovation and develop regulatory processes that can deliver innovation quickly to the people who need it most.

We want FDA to be a gateway, not a barrier…linking scientific opportunity and unmet need.

You are all here today because you are taking action by developing what I am hopeful will be an effective solution to this devastating problem. I applaud all the partners involved in this initiative—my friends from industry, from civil society, from academia and from the advocacy community—for taking a risk and for being innovative against a disease that has eluded all of us for so long.

Good luck and thank you. It has been a pleasure to be here today.