Jack Klugman’s secret, lifesaving legacy

[Retro4Life]

The actor Jack Klugman died on Christmas Eve at age 90. Klugman was best known for his roles as the unkempt sportswriter in “The Odd Couple” and as the crusading medical examiner on “Quincy, M.E.” the wildly popular 1980s medical drama. Few people remember it today, but he also played an instrumental role in passing critical health-care legislation, the Orphan Drug Act, through Congress in the early 1980s, using “Quincy” and his own celebrity to roll Sen. Orrin Hatch (R), who was blocking the bill.

Tony Randall, left, and Jack Klugman play a scene in the ABC comedy television series “The Odd Couple.” But Klugman did more than you might realize. (AP)

Klugman’s unlikely star turn in Washington stemmed from a 1980 hearing by the House Subcommittee on Health and the Environment on the problem of developing treatments for rare diseases. The problem was that many terrible diseases didn’t afflict enough people to entice pharmaceutical companies to develop treatments. Hence they were ”orphan” diseases. They included Tourette’s syndrome, muscular dystrophy, cystic fibrosis, spina bifida, ALS and many more. The situation was especially tragic because scientists who discovered promising treatments often couldn’t interest drug makers, who didn’t see potential for profit.

The issue of orphan diseases was so obscure that only a single newspaper, the Los Angeles Times, sent a reporter to the hearing (and the Times only did so because a local boy suffering from Tourette’s testified). But the article caught the eye of a Hollywood writer and producer named Maurice Klugman, who himself suffered from a rare cancer and also happened to be Jack Klugman’s brother. Maurice Klugman wrote an episode of “Quincy” about Tourette’s and the orphan drug problem.

To capitalize on the publicity and build momentum for a bill, Rep. Henry Waxman (D) of California, the subcommittee chairman, invited Jack Klugman to testify before Congress. Nowadays on Capitol Hill, you’re as likely to run into Bono or Ben Affleck as your own representative. But at the time, a bona fide celebrity speaking to Congress was a huge deal. The New York Times ran a front-page story on Klugman and orphan diseases. That led to a bill with three big incentives for drug makers: a lighter regulatory burden for developing new orphan drugs, a seven-year monopoly, and a 90-percent tax credit for the cost of clinical trials. It also established an Office of Rare Diseases at the National Institutes of Health.

The Orphan Drug Act of 1982 sailed through the House. But it ran into trouble in the Senate. Hatch, whose committee had jurisdiction, amended the bill to include a cancer research and screening center in his home state of Utah. But to protect the bureaucratic turf of his colleagues on the Finance Committee, which oversees tax policy, Hatch stripped the tax credit, neutering the bill, which the Senate then passed unanimously. Waxman and his allies in Congress and the medical community pushed frantically to revive the tax credit, without any luck.

In a fit of pique, Jack Klugman hit upon a novel idea. He and his brother wrote a second “Quincy” episode, this one revolving around an orphan drug bill that was being held up by a heartless (fictitious) senator. In the pivotal scene, Quincy confronts the senator in his office and demands that he look out the window. Peering down, the senator sees a huge crowd gathered with signs that read “We Want the Orphan Drug Act” and relents. To shoot the scene, the show’s producers hired 500 extras who really did suffer from rare diseases.

Hatch, too, finally relented. Thanks to Klugman, the Waxman-Hatch Orphan Drug Act became law in 1983. In an ending Hollywood might have scripted, it has been a remarkable success. The FDA has approved more than 300 orphan drugs, with 1,100 more under development. One of the first developed under the law was AZT, the early AIDS treatment. Two years later, Congress expanded the law to include biological and chemical drugs, which helped spur the biotech industry.

Klugman’s distant influence continues to live on in the current Congress. It didn’t get any attention, of course, but earlier this year, in a rare feat of bipartisan decency, Congress passed the Creating HOPE Act for pediatric cancer research. The law relies on the same model as the Orphan Drug Act, offering pharmaceutical companies various regulatory and marketing incentives to devise new treatments for rare cancers that strike children, but aren’t seen as sufficiently profitable for drug makers to pursue on their own.

All in all, an impressive addendum to Klugman’s acting career. May he rest in peace.

http://www.washingtonpost.com/blogs/...saving-legacy/