summer-2003-Part 2-live - Nieman Foundation - Harvard University

Medical ReportingDisputing the ‘Tale’This 1908 fraudulent newspaper ad led to a Supreme Court decision that the FDA couldnot crack down on therapeutic claims. In response, President William H. Taft askedCongress to override the decision. It did, but prosecuting such claims remains difficult.Courtesy of The Office of History at the Food and Drug Administration.drug company research and manufacturing.In fact, when British scientistshad the first batches of aworkable penicillin in hand in May1940, they took them to one drugcompany after another, offering thebrilliant discovery for free to anycompany that would do the developmentand marketing. British companiesturned them down, and thescientists flew to the United States,certain that the wealthy Americanswould jump at a chance to marketthe miracle drug. American companiesturned them down flat. Toorisky an investment, they said. Instead,the scientists turned to scientistsworking in government labs;they accepted the challenge the sameday it was offered, and during thenext year carried out the most crucialwork in the drug’s development.Then, after the United States enteredthe war, the U.S. governmentasked the companies to join in nowthat important progress had beenmade. The companies still balked.Finally, they were all but ordered towork on penicillin for the sake ofthe troops. The companies weregiven financial incentives as well and,finally, belatedly, agreed to work onpenicillin.• After the AIDS epidemic started andwas identified as a viral plague, scientistsand public health advocatesurged American companies to beginwork making anti-AIDS drugs. Butthe companies balked; the investmentwas too risky. Perhaps the epidemicwould go away, or not enoughpeople would get sick to make adrug profitable, analysts said. So itwas that the first three vital drugsagainst AIDS came not from industrybut from work in governmentlaboratories.Reading the record of regulationclosely, it appears that the tale of theterrible regulators is just that, a tale. Ithas sprung from a belief in a too-simpletheory of economics, the market ideal.But this belief holds great sway inAmerica in these times.Because of the conflict between thetales and the facts of food and drugregulation that I kept finding in myreporting, eventually I decided to documentit in a book. I found that the truestory of regulation and business hasbeen that modern medical science hasmoved forward by willing and unwillingcooperation between them. Modernmedicine could not have happenedwithout this synergy. The role of theregulator was not that of a barrier; itwas that of a goad. Regulation set highscientific standards that businessesnever would have set or met on theirown, and progress has depended onhigh research standards. Without them,the proof that an advance is really anadvance might never come.Of course, the tales of the terribleregulators go on. And young journalistsare faced with the same difficultchoices. They can quote those who aretelling the “tale” and move on, whiletrying to bring to bear skepticism theymight feel. Or they can take a risk—askfor extra time and try to dig up factsthat can put these “tales” in their propercontext. Take this route and they mightirritate editors, sources and the organizationsthey are questioning. And theymight mark themselves as problemcases, especially if they fail to documenttheir suspicions and end up witha weak story or no story.Chasing this second kind of story isa lot harder. But once in a while, settingthe record straight on one or twowhoppers can make the risk worth it. ■Philip J. Hilts, a 1985 Nieman Fellow,has covered health and sciencefor The New York Times and TheWashington Post. He is the author offive books. His most recent is “ProtectingAmerica’s Health: The FDA,Business and One Hundred Years ofRegulation” (Alfred A. Knopf, 2003).philts@botsnet.bw34 Nieman Reports / Summer 2003