Tuesday, June 8, 2004

Many want to honor the memory of former President Reagan by increasing National Institutes of Health’s (NIH) support for university and private-sector stem-cell research. Because stem-cell research offers a possible cure for Alzheimer’s disease, the illness that afflicted the former president, as well as countless other illnesses, such a move might seem fitting. But a truer tribute to the president and to the medical progress those would secure by invoking his death would be to reaffirm the policies that he himself crafted to launch America’s biomedical revolution.

Ronald Reagan’s role in promoting medical progress began with the passage of the Orphan Drug Act in 1983, a law that gives companies seven years of market exclusivity, fast-track approval and tax credits for investing in drugs for rare diseases. Before the Orphan Drug Act, the high cost of getting a drug through the Food and Drug Administration made such investment nearly impossible. Attention to the problem and legislation proposed by Congressman Henry Waxman was scarce until Jack Klugman, the star of “Quincy,” did two shows around the issue of federal inaction on orphan drugs and testified before Mr. Waxman’s subcommittee.

The Orphan Drug Act had passed both houses of Congress, but Reagan administration officials wanted the president to veto the bill because of the tax credits. Mr. Reagan, hearing that “Quincy was coming to town” to drum up support for the bill, would have none of it. Characteristic of Mr. Reagan’s pragmatism and vision, he ignored the veto recommendation and signed the bill. With Messrs. Waxman and Klugman and other supporters looking on, the president said, “I only wish with the stroke of this pen I could also decree that the pain and heartache of people who suffer from these diseases would cease.” Twenty years later, there are 250 orphan drugs on the market, with nearly 1,000 more in the pipeline. As a result, people with rare diseases have seen their life expectancy increase faster than society as a whole.

During his tenure as president, two laws were passed to encourage private investment in discoveries and developments made by or with grants from federal research labs. The law allowed small businesses and nonprofit organizations title to own inventions that emerged from cooperative ventures, as long as they spent the money to patent and develop the discovery. But drug development and collaboration did not take off under the laws until Mr. Reagan issued an executive order to include all private companies, for-profit subsidiaries created by university labs and other partnerships. Then he pushed for and won passage of the Federal Tech Transfer Act of 1986, which established cooperative research and development agreements (CRADAs).

Under a CRADA, federal labs can transfer technologies like most every other public- and private-sector organization worldwide — negotiating royalties and exclusive use for future research purposes without any pricing restrictions or oversight. Joint ventures under the CRADA arrangement have greatly benefited the public health and the NIH. Without them, the first AIDS medicines, such as AZT and DDI — both of which were orphan drugs as well — might have been developed many years later or never been successfully produced. Hundreds of other CRADAs involve cutting-edge medicines to treat cancer, stroke and Alzheimer’s.

And while Mr. Reagan was excoriated for not caring about the emergence of the AIDS epidemic, in fact his administration worked closely with AIDS activists to accelerate approval of the first HIV drugs in development. Behind the scenes, administration officials and AIDS activists pressured the FDA to come up with ways to reduce dramatically the time and money required for approval and to allow people early access to medicines through expanded and non-randomized clinical trials. These techniques were the beginning of the FDA reform movement that continues today.

These very policies that would ensure that increased federal support of stem-cell research leads to a massive investment of America’s wealth and scientific ingenuity in a new generation of cures are under assault by some the same forces that want to use stem-cell research to pay “tribute” to President Reagan. They see the growth of private investment in biotechnology and new medicines, and see only greed, danger and despair. They — and some of them are self-styled Reagan Republicans — now call for importation, price controls, cuts in the orphan drug law, slower FDA drug approvals, proposals to have the government seize — instead of award — patents to companies that work with or invest in federal researchers to force down drug prices.

Today Washington is full of handwringers over the cost of the newest medicines, even those breakthroughs that could curtail cancer or wipe out heart disease in our lifetime. By contrast, Mr. Reagan often declared: “We could put a price tag on the value of these human benefits, but who would want to do that? Who can even imagine the wonders that lie ahead if we just have the faith and the courage to push on?” Should we stay frozen with fear and filled with envy at this point in the biomedical revolution or show we move forward knowing that everything is before us?

Those wishing to honor Ronald Reagan and ensure brighter, not bitter, lives for people with Alzheimer’s surely know which step to take.

Robert Goldberg is director of the Center for Medical Progress at the Manhattan Institute for Policy Research.

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