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FOR IMMEDIATE RELEASE
Thursday, May 10, 2001
Contact: HHS Press Office
(202) 690-6343

Remarks by HHS Secretary Tommy G. Thompson
Press Conference Announcing Approval of Gleevec for Leukemia Treatment


Today I have the privilege of announcing a medical breakthrough.

Like most scientific breakthroughs, this one is NOT sudden, nor does it stand alone. Rather, like most scientific advancement, it is a culmination of years of work and years of investment, by many people in many different institutions, and even in different fields of medicine.

We are here to announce one dramatic product of all those efforts. But we believe many more products will follow, based on years of scientific groundwork.

So this is the right time to acknowledge those efforts, to recognize that our investments in research are paying off, and to praise the teamwork that has brought us here. It's also the right time to talk about what this can mean for our future - a future that promises a new level of precision and power in many of our pharmaceutical products. Today the Food and Drug Administration has approved a new drug, Gleevec, for treatment of chronic myeloid leukemia -- or CML.

You'll hear more about this drug later. Let me just say that it appears to change the odds dramatically for patients. And it does so with relatively low occurrence of serious side effects.

That's because this drug has been engineered in the laboratory to target a single cancer-causing protein and -- like a light switch -- turn off its signal to produce leukemia cells. It's designed to kill leukemia cells while leaving the normal white blood cells alone.

If this does not sound like the same arduous chemotherapy regimen that one of your friends or loved ones has received in years past, that's because it isn't. This oral drug is based on the concept of molecular targeting -- and we believe such targeting is the wave of the future.

A wave of scientific progress in which researchers find the bad circuit buried inside of a tumor cell. They craft a drug in the laboratory to shut off its erroneous, cancer-causing signal. Then they deliver the drug directly to the cancer cells, leaving the healthy cells alone.

Today, we celebrate Gleevec, but we also have good reason to think that there may be other Gleevecs under development in our nation's laboratories, medical centers, and drug companies. We need to do all we can to develop these drugs and get them to the people waging their own personal battles against cancer.

I also want to highlight this new cancer drug because it epitomizes the type of scientific research that is taking place in America today, in the public and private sectors.

We are on the cusp of so many breakthroughs in ways to treat diseases that were previously untreatable, or at least untreatable without painful side effects and uncertain results. We're on the path to finding cures to diseases that have long plagued humans, such as leukemia and other cancers.

This breakthrough underscores the importance of continued investment in research in this country. The President is giving research the highest of priorities in his administration.

In his budget, the President increases spending for the National Institutes of Health by $2.75 billion next year and double 1998 spending levels by 2003. A cornerstone of the budget proposal for NIH is an increase of $514 million for cancer-related research in 2002 -- a 12 percent increase over fiscal year 2001.

The President believes in the power of research. He understands that the payoff for scientific investment stands to be tremendous for the health of millions of Americans.

And here at HHS, throughout our agencies, we are committed to aggressively pursuing the medicines and scientific discoveries that will help us better tackle hideous diseases and improve the quality of health for our citizens.

Scientists in government, academia, and industry have been laying the foundation for molecular targeting for several years. They've recognized that it represents an exciting and promising approach in cancer research. And speaking for the president and scientists in my department, especially at National Cancer Institute, I know that they will not let up in the future.

The truth is that we are here today because of teamwork and collaboration. I cannot overemphasize the importance of this point. Dr. Brian Druker of the Oregon Health Sciences University and scientists at Novartis Pharmaceuticals have worked in tandem to bring Gleevec to market. They have done a remarkable job. And joining in the long-term effort have been many colleagues from other medical centers and the NCI.

The Food and Drug Administration has also contributed to this remarkable project, by awarding Gleevec the status of an orphan drug to add incentive to its development, and by reviewing Gleevec in just two-and-a-half months. That is an all-time record for the evaluation of a highly complex, novel drug.

Today, Gleevec arrives as a remarkable new medicine for people with CML. It arrives as a proof of principle for molecular targeting in cancer care. It arrives based on a firm foundation of research investment -- a foundation we intend to continue nourishing. And, it arrives as a testament to the "can-do" attitude and will of our nation's scientific community.

That's a lot to celebrate -- and a tall order for continued progress in the future.

FDA's press release on Gleevec is available at www.fda.gov/bbs/topics/NEWS/2001/NEW00759.html

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Note: All HHS press releases, fact sheets and other press materials are available at www.hhs.gov/news.