Updated: Aug 12
I don't review too many books, but after reading Wonder Drug by Jennifer Vanderbes, I couldn't help myself. I posted it on Amazon, where it'll hopefully show up in the next few days, but thought I'd post it here as well--it's THAT good.
"Jennifer Vanderbes's Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims is an enthralling, impossible-to-put-down exploration of one of the great tragedies perpetuated by drug companies upon unsuspecting (and trusting) victims. The drug, Thalidomide (sold and "freely" distributed under various names and derivatives as a sedative in the late 1950s and early 1960s), caused phocomelia (a shortening of the "limb/s being reduced or missing and leaving distal elements (handplate) in place" (National Institutes of Health). If you've ever seen a thalidomide baby, you've likely seen a photograph of a baby with "flipper-like" hands and/or feet. Many of those babies are now in their sixties; plenty died or were forgotten about once they were born, swaddled and pulled from their mothers and either put in homes or taken care of in other ways.
The William S. Merrell Company had been inundating medical facilities with pills that were causing severe birth defects, passing the pills off as remedies for such things as insomnia, morning sickness, and headaches, and it indeed felt like a "wonder drug." But the truth of that wonder drug was far from what was being claimed. It soon became apparent that “ten thousand babies worldwide” at the time were killed or born with deformed limbs and/or defective organs due to the drug. As I read these facts and as a father myself, I couldn’t fathom what these parents had gone through. It angered me.
The evolution and importance of the FDA, and how it altered the safety of the American public, materialized during the time of the thalidomide tragedy. But it was a slow process.
The story of thalidomide as a tested and effective drug reviewed by doctors and scientists was horrific. From Nazi experimentation with the drug in concentration camps to a lack of due diligence by the gatekeepers of healthcare around the globe, patients seeking relief from various ailments were treated as Guinea pigs. Many of them died, yet doctors continued to prescribe the drug, even before animal testing was completed, if any testing was ever completed at all. To say that the industry dropped the ball would be to put it mildly. But no one seemed to care, except a brave, inquisitive, and tough Dr. named Frances Kelsey, who brought thalidomide's dangers to light and pushed for its halt as the drug of choice for so many doctors.
The scientific evaluations being done were too rushed, but, for the drug companies, the profits were too tempting. Inevitably, due to the rules of the game at the FDA, those testing the medications had 60 days to kill them. But 60 days often wasn’t enough time to conduct the trials. And so the runaway trains of profit over people were set free.
The reality was that the politics of the early days of the FDA and its association with the drug manufacturers it was supposedly overseeing was not what it is today. What it was during the days of thalidomide's introduction into the hands of patients can be considered criminal. Profits above human decency seemed the norm. Trials were either not performed, performed inadequately, or simply overlooked in terms of what the actual results were. Thalidomide, or Kevadon, as it was called by the drug manufacturer Richardson-Merrell, was pushed to the public the way a street corner drug dealer pushes their product to their neighborhoods—except it was much worse, because Merrell had the financial ability to market their drugs heavily, all while sending an army of detail men (sales reps) to supplement demand.
Time and again, the need, or the results, of safety research, was sidelined, all for the profit of the companies hawking pills that would ultimately be proven lethal or extremely damaging, in particular to the unborn children of women given the medicine.
Vanderbes is brilliant at breaking down the way the medicine makes its way from the manufacturer to the detail men, to the receptive doctors or "clinical investigators" who would provide the drugs to their patients (these doctors were known as Dr. Backslappers), who then prescribed the meds to patients (or passed them along to other doctors, who were not clinical investigators), effectively making it impossible for accountability if anything went wrong, as the chain of custody of the medicine was lost.
In the hurricane of drug pushing for profit, ethical, detail-oriented doctors at the FDA like Dr. Frances Kelsey, sought to put a stop to the Wild Wild West days of profits over patients.
Yet the immorality of some of the doctors involved with the thalidomide tragedy, including a thoroughly repugnant study they executed on minors with brain damage in Bonn, Germany (where the drug was known as Contergan) is mind-boggling. That so many doctors went along with human trials of a drug proving fatal to so many will leave the reader not only astonished but wondering how such a thing could happen at all.
But what Vanderbes does so well is shed light on exactly how something so horribly wrong and unethical could happen in the shadow of WWII and in the 20th century, given all the progress the world had made. Shady business relationships between medical companies and medical journals was one factor that contributed to the problem. Another was that doctors who wished to publish their findings about the harmful effects of Thalidomide were often “delayed.” Yes, the world was different back then, but one has to ask themselves, Where was the decency? Where was the morality of all involved? Had these people and companies no shame?
Time after time after time, the drug companies selling Thalidomide hid any mention of safety findings related to the cash cow drug lining their pockets. Some of the companies outright lied, or contrived ways to get around halting the sale of it, which, by 1961, was in about 42 countries. Babies were being born with extremely malformed limbs and other birth defects, and the mothers and families of these children were being kept in the dark as to why. Responsibility was a game of hot potato no one wanted to play. so no one was held to account. Not the doctors, who didn’t have to tell patients what they were giving them, nor that the drugs they were being given had reported birth abnormalities, not the drug companies, who misled the FDA, nor, it seemed, anybody else involved with the spread of the wonder drug.
To mitigate the losses that acknowledging the drug's issues might cause, A Merrell press release “affirmed that thalidomide was ‘never sold in the United States.’" But as Vanderbes makes clear, “sold” did not mean not distributed. "At the time of Merrell’s “premarket distribution of [thalidomide, it was] . . . the largest in U.S. history.”
But then, in 1960, things began to change. A paper was published in the British Medical Journal, and the FDA in America caught on. Merrell was eventually found to have put the drug out into the market and then suppressed data and submitted false data in its Kevadon application. More companies followed suit. Once it was abundantly clear that the house of cards would fall, Grunenthal, the German seller of the drug, settled with its affected patients, rather than go to trial. But the damage was done. 150,000 worldwide victims were affected, 45 nations had thalidomide in circulation, and, in effect, it was still the Wild Wild West on who had thalidomide and where it was still being prescribed (or given out).
While Thalidomide was later found to be beneficial for treating certain symptoms of AIDS and leprosy, the WHO (the World Health Organization) put the kabash on its use due to “murky” research on the drug’s efficacy. Things have changed recently with how thalidomide and its variants are used, but none of this changes what happened to the thousands upon thousands of victims whose lives were either cut short or adversely affected for the duration of their entire lives.
To mitigate the losses that acknowledging the drug's issues might cause, A Merrell press release “affirmed that thalidomide was ‘never sold in the United States.’" But as Vanderbes makes clear, “sold” did not mean not distributed.
Vanderbes's book is a must read, especially if you want to get a detailed understanding of how drug companies used to work (and hopefully a reminder of how things have changed since those days). It's also a history lesson in what women had to do in order to succeed in educational and career opportunities where the organizations they wanted to be a part of were overwhelmingly chauvanistic. The drug companies and even the FDA were geared towards men, directed by men, and the entire industry was controlled by the profit specific men reaped through the sale of thalidomide and other drugs. Women like Dr. Frances Kelsey and others paved the way for change. They were the champions of patients being lied to, manipulated, and physically and mentally affected by everything the drug companies in their quest for profits brought down upon them with neither their consent nor knowledge. What happened to the patients of thalidomide is horrific, and Vanderbes's book is a testament to why such a travesty should never happen again. Buy the book, and read it. Now. As a participant in the health industry, whether as a patient, a doctor, or any other role you may hold when it comes to healthcare, you should be aware of the history of thalidomide, if even just to know what to look out for any time a doctor says, "I'd like to prescribe you this . . . ."
You can donate to Thalidomide survivors here
Jennifer Vanderbes is novelist, journalist and screenwriter whose work has been translated into sixteen languages. Her writing has appeared in The New York Times, The Wall Street Journal, The Washington Post, The Atlantic, and Granta. She has received awards from the Guggenheim Foundation, the New York Public Library, the Sloan Foundation, the National Endowment for the Humanities and the New York Council for the Arts. She lives in New York City with her daughters.
For more information visit www.jennifervanderbes.com