Wonder drug : the secret history of Thalidomide in America and its hidden victims

“A shocking saga of pharmaceutical malpractice . . . Wonder Drug is both a first-rate medical thriller and the searing account of a forgotten American tragedy.”—Patrick Radden Keefe, author of Empire of Pain A page-turning account of the most notorious drug of the twentieth century and the never-before-told story of its American survivors. In 1959, a Cincinnati pharmaceutical firm, the William S. Merrell Company, quietly began distributing samples of an exciting new wonder drug already popular around the world. Touted as a sedative without risks, thalidomide was handed out freely, under the guise of clinical trials, by doctors who believed approval by the Food and Drug Administration was imminent. But in 1960, when the application for thalidomide landed on the desk of FDA medical reviewer Frances Kelsey, she quickly grew suspicious. When she learned that the drug was causing severe birth abnormalities abroad, she and a team of dedicated doctors, parents, and journalists fought tirelessly to block its authorization in the United States and stop its sale around the world. Jennifer Vanderbes set out to write about this FDA success story only to discover a sinister truth that had been buried for decades: For more than five years, several American pharmaceutical firms had distributed unmarked thalidomide samples in shoddy clinical trials, reaching tens of thousands of unwitting patients, including hundreds of pregnant women. As Vanderbes examined government and corporate archives, probed court records, and interviewed hundreds of key players, she unearthed an even more stunning find: Scores of Americans had likely been harmed by the drug. Deceived by the pharmaceutical firms, betrayed by doctors, and ignored by the government, most of these Americans had spent their lives unaware that thalidomide had caused their birth defects. Now, for the first time, this shocking episode in American history is brought to light. Wonder Drug gives voice to the unrecognized victims of this epic scandal and exposes the deceptive practices of Big Pharma that continue to endanger lives today. “A shocking saga of pharmaceutical malpractice . . . Wonder Drug is both a first-rate medical thriller and the searing account of a forgotten American tragedy.”—Patrick Radden Keefe, author of Empire of Pain A “fascinating and compassionate” ( People ) account of the most notorious drug of the twentieth century and the never-before-told story of its American survivors. Longlisted for the Andrew Carnegie Medal In 1959, a Cincinnati pharmaceutical firm, the William S. Merrell Company, quietly began distributing samples of an exciting new wonder drug already popular around the world. Touted as a sedative without risks, thalidomide was handed out freely, under the guise of clinical trials, by doctors who believed approval by the Food and Drug Administration was imminent. But in 1960, when the application for thalidomide landed on the desk of FDA medical reviewer Frances Kelsey, she quickly grew suspicious. When she learned that the drug was causing severe birth abnormalities abroad, she and a team of dedicated doctors, parents, and journalists fought tirelessly to block its authorization in the United States and stop its sale around the world. Jennifer Vanderbes set out to write about this FDA success story only to discover a sinister truth that had been buried for decades: For more than five years, several American pharmaceutical firms had distributed unmarked thalidomide samples in shoddy clinical trials, reaching tens of thousands of unwitting patients, including hundreds of pregnant women. As Vanderbes examined government and corporate archives, probed court records, and interviewed hundreds of key players, she unearthed an even more stunning find: Scores of Americans had likely been harmed by the drug. Deceived by the pharmaceutical firms, betrayed by doctors, and ignored by the government, most of these Americans had spent their lives unaware that thalidomide had caused their birth defects. Now, for the first time, this shocking episode in American history is brought to light. Wonder Drug gives voice to the unrecognized victims of this epic scandal and exposes the deceptive practices of Big Pharma that continue to endanger lives today. A riveting account of the most notorious drug of the twentieth century and the never-before-told story of its American survivors. In 1959, a Cincinnati pharmaceutical firm, the William S. Merrell Company, quietly began distributing samples of an exciting new wonder drug already popular around the world. Touted as a sedative without risks, thalidomide was handed out freely, under the guise of clinical trials, by doctors who believed approval by the Food and Drug Administration was imminent. Butin 1960, whenthe application for thalidomide landed onthe desk of FDA medical reviewerFrances Kelsey, shequicklygrewsuspicious.Whenshelearned that the drug was causing severe birth abnormalities abroad, she and a team of dedicated doctors, parents, and journalists fought tirelessly to block its authorization in the United States and stop its sale around the world. Jennifer Vanderbes set out to write about this FDA success story only to discover a sinister truth that had been buried for decades: For more than five years, several American pharmaceutical firms haddistributedunmarkedthalidomide samplesin shoddy clinical trials, reaching tens of thousands of unwitting patients, including hundreds of pregnant women. As Vanderbes examined government and corporate archives, probed court records, and interviewed hundreds of key players, she unearthed an even more stunning find: Scores of Americans had likely been harmed by the drug. Deceived by the pharmaceutical firms, betrayed by doctors, and ignored by the government, most of these Americans had spent their lives unaware that thalidomide had caused their birthdefects. Now, for the first time, this shocking episode in American history is brought to light. Based on thousands of previously unseen documents and over three hundred interviews that spanned three continents, Wonder Drug lays bare a shocking episode in American history. This landmark expos finally gives voice to the unrecognized victims of the 20th century's most notorious drug. "When the application for a new sedative called Kevadon--commonly known as thalidomide--landed on Frances Kelsey's desk at the FDA in 1960, it seemed destined to sail through the review process. The drug, billed as entirely risk-free, was already being sold in forty-six countries. But when Kelsey learned that the drug caused terrible birth defects, she and a team of dedicated doctors, parents, and journalists fought Merrell, the drug's American manufacturer, and Chemie-Gruenenthal, the German company founded by former Nazis that first synthesized the drug, to recall the product. It marked a rare victory in America's perennial battle between capitalism and consumer protection. Though Kelsey received a presidential medal and a LIFE magazine photo spread of European children missing limbs shocked American readers, an essential chapter laid buried for decades. Jennifer Vanderbes discovered that even though Frances Kelsey refused to approve Merrell's application to "sell" thalidomide in the United States, the drug firm, under the guise of clinical trials, had quietly sent millions of pills to doctors nationwide. Years before that, an additional drug company had asked doctors to test the drug on patients. The toxic sedative that was ostensibly "never sold" in America had, in fact, been distributed for five years, reaching tens of thousands of unwitting patients, including hundreds of pregnant women"-- Provided by publisher