I am not an alarmist, but when I finished reading Bottle of Lies: The Inside Story of the Generic Drug Boom, by Katherine Eban, all I could think was, “how the (strong expletive) could this possibly be happening?”
This exhaustively researched book reads as part documentary, part crime novel, and includes a cast of characters both hero and villain. The victims are, potentially, anyone who takes an off-brand (generic) drug; and I mean you, me––literally, anyone from any country. This is not an isolated problem.
Katherine Eban, is an investigative journalist who spent ten years delving into the shenanigans of global generic drug makers and the under-resourced regulators charged with overseeing them––in the United States, this is the Food and Drug Administration (FDA). The result is a book that is gripping and deeply troubling as it uncovers deception on a global scale.
The drama starts in the 1980s with the HIV/AIDS crisis. There was a political push to bring cheaper generic drugs to market as the brand name medicines were too costly for most patients. Brand name drug companies battled with generic drug makers and regulators over intellectual property, while thousands of people who could not afford treatment died.
Eventually, Indian companies were granted FDA approval to sell affordable generic drugs to Africa to help with the AIDS crisis. It was then thought that “if Indians could make affordable medicine good enough to be approved by American regulators, then the drugs were good enough for Americans to take too.”
So, over the ensuing decades, India has emerged as a major provider of generic medicines globally. Unfortunately, we did not (and some might say we still do not) have a robust system in place to ensure these drugs are safe and effective.
Generic drugs cost, on average, about 20% less than a brand-name counterpart. But, the term “counterpart” is where some of the trouble lies. A generic drug is required to be bioequivalent to its brand-name version. This means it should have the same therapeutic effect; be administered in the same way; have the same dosage and strength formulations. Essentially, the manufacturer has to prove that its generic drug works the same as the brand name version before it is allowed to be sold in the United States and many other countries. And this is where the shenanigans come in.
Generic drugs are mostly made in countries where labor is cheaper and regulations less stringent. India hosts the lion’s share of generic drug manufacturers and has been spotlighted, time and again, for being the nexus for many of the irregularities. (But India is not alone in getting away with fraudulent, unsafe manufacturing processes.)
The FDA is responsible for ensuring the quality and safety of our medicines, but with much of the manufacturing occurring offshore where it does not have legal jurisdiction or adequate in-country resources, oversight is spotty.
Bottle of Lies reveals how effectively many major international drug makers have managed to obstruct and deceive regulators. Even when the FDA has learned of drug maker fraud and obfuscation it has failed to hold companies and individuals accountable.
It should surprise no one that money is the root of the problem. India’s generic drug manufacturing industry is too big to fail, and the U.S. is under enormous pressure to lower drug costs. Each side is highly motivated to ensure the generic spigot stays open.
Bottle of Lies details incidences where the FDA has cut regulatory, safety and accountability corners with the companies it is charged with overseeing. If people cannot access affordable generics because the FDA has shut down the factory––even if due to significant drug safety concerns––Congress and patients (voters) are unhappy, and international relations are impacted. Drug safety and supply are intertwined with politics and profiteering.
(NB: As an Amazon Associate I earn from qualifying purchases.)
The drug manufacturers are motivated solely by profits. They go to great lengths to show that their drugs are safe and effective without actually making sure that they, indeed, are safe and effective. It is all smoke and mirrors, and companies have become highly skilled at deception.
Testing is incomplete and documents are routinely created, altered, or destroyed in order to provide data that will lead to FDA approval. Whistleblowers are ignored and/or punished; ethical people get fired; companies are allowed to ship drugs that are known to be unsafe or ineffective; and very few people, if any, are held accountable.
Bottle of Lies reads like a thriller, which is troubling given the book is non-fiction. It offers little in the way of relief in terms of personal action that the reader might take.
The drug manufacturers are motivated solely by profits. They go to great lengths to show that their drugs are safe and effective, without actually making sure that they, indeed, are safe and effective.
CBS News reported on this issue in May 2019, saying, “One of the problems here is the lack of public information if you’re curious about where your medication is coming from. You can ask your pharmacist which company made your generic medication, but you’ll have to do some research to figure out whether that company has ever had to recall products or has been found to have manufacturing issues. And it’s difficult — if not impossible — to find out where the companies actually make each drug. The FDA says that’s considered “confidential information” under federal law.”
It’s hard to know whether the generic landscape is truly changing. The FDA certainly defends its practices and the safety of the drug supply. My sense is that safety and efficacy occur on a prescription-by-prescription basis––many doses might meet standards; the question is, what about the drug I am taking today? I would certainly be telling my doctor the moment medication is not working or is making me feel unwell.
Katherine Eban provides a nice summary in the Author’s Note. “Generic drugs are essential to our health care system, and their quality is critical to us all. Nonetheless, in my effort to answer the question that Joe Graedon posed ten years ago––what is wrong with the drugs?––I uncovered the labyrinthine story of how the world’s greatest public health innovation also became one of its greatest swindles.”
I truly hope the villains and their playbooks have been corraled, but I think this is unlikely given the profits at stake and the huge challenges involved in effectively overseeing off-shore manufacturing.
Bottle of Lies: The Inside Story of the Generic Drug Boom.
(NB: As an Amazon Associate I earn from qualifying purchases.)