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Points Bookshelf: “Bottle of Lies” by Katherine Eban

Updated: Aug 29

Editor’s Note:  Today’s post comes from contributing editor Brooks Hudson, a PhD student in history at Southern Illinois University. As part of our Points Bookshelf series, he reviews Bottle of Lies: The Inside Story of the Generic Drug Boom (Ecco, 2019). 

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Bottle of Lies’s popularity and positive press stems from Eban asking what appears, at first blush, to be a naïve set of questions: What are generic drugs? How are they made? Where are they made? And what are the consequences? If you surveyed the American people’s knowledge of what a generic drug is, they would probably say something to the effect of “generic drugs are the cheaper version of the name-brand.” “Patients” Eban writes, “tend to assume that their generic drugs are identical to brand-name drugs in part because they imagine a simple and amicable process: as a patent expires, the brand-name company turns over its recipe, and a generic company makes the same drug, but at a fraction of the cost.”

It doesn’t happen this way. Instead companies, “erect a fortress of patents around their drugs, sometimes patenting each manufacturing step—even the time-release mechanism, if there is one. At any point, they can tweak a drug “declare it new, to add years to their patents, a move known as ‘evergreening.’” Whatever generics hit the market, they arrived there “not with help from brand-name drug companies, but in spite of their efforts to stop them.”

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Katherine Eban

Eban describes how a chemist creates generic drugs. It reminded me of those Gourmet Makes videos with Claire Saffitz reproducing America’s favorite snacks (Twinkies; Pringles). Like those videos, the process involves reverse-engineering, dismantling parts, putting things back together, adding “excipients” (extra stuff) to replicate the original. Where generic drugs and Gourmet Makes depart, unfortunately, is that pharmaceuticals’ supply chains are opaque. 

Eban shows how the generic boom was a consequence of the AIDS epidemic. Africa and India, the places least equipped to deal with an AIDS outbreak, were the epicenters. Three drugs were effective at controlling the virus, but western companies owned the patents to them. A year’s supply came with a price tag between $10,000 and $15,000. The firms saw no reason to budge. In India, Dr. Hamid, the CEO of Cipla, a generic firm, saw outside the company’s headquarters how dire things would be if AIDS couldn’t be contained. He asked a company chemist to estimate the lowest price for which they could produce generics. His calculation came back: $1 a day.

News organizations made it into a headline. Through partnerships with nonprofits, they slashed it down to a mere 38 cents a day ($138/year). Eban writes that this “led to a realization that would in short order upend the generic drug industry and transform the American drug supply: 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.” The integrity, goodwill and humanitarian motivations of Dr. Hamid and Cipla proved to be the exception, however. Firms abandoned domestic production. As they did, they saved staggering sums—in labor, environmental and regulatory costs. Savings circulated back into their coffers and any pretense this transition would lead to cheaper high-quality drugs soon slipped by the wayside. 

Dinesh Thakur and Peter Baker act as the book’s protagonists. Thakur, a Ranbaxy employee turned whistle blower, was acting as head of research information for the company when he discovered that “more than 200 products in more than 40 countries had elements of data that were fabricated to support business needs.” Company scientists, he confirmed to the FDA, substituted low-quality ingredients and “altered test parameters so that formulations with higher impurities could be approved.” To “generate optimal results, they crushed up brand-name drugs into capsules so they could be tested in lieu of the company’s own drugs.” Ranbaxy even used teams of “employees [who] backdated documents and then artificially aged them in a steamy room overnight in an attempt to fool regulators during inspections.”

The drugs Ranbaxy produced were harmful. They sometimes lacked active ingredients or contained impurities, and for patients, this exacerbated health problems, caused unnecessary hospitalizations and even resulted in death. Before Thakur became a whistleblower, he gathered information on the company and created a Power Point presentation for a subcommittee of the company’s executives, hoping they’d share his concerns about defective drugs and the threat it posed to patients and the company’s bottom line. His hopes were dashed. After ending the slideshow, he received two questions: Had the computer he wrote this on been destroyed? Were there any other copies? If this report ever leaked, it would jeopardize everything.  

Peter Baker acts as the other protagonist. In one interview, Eban described Baker as a 32-year-old “motorcycle-riding, tattooed tough guy who was up for an adventure.” As a reader, his main asset was basic: decency and a deep commitment to preventing deadly, tainted drugs from entering the United States. Beyond that, what set him apart was his ability to fashion an ad-hoc method for detecting computer fraud and manipulation. Even though Ranbaxy and the other companies he inspected gamed the system, they still needed the raw data for it to succeed. By scouring metadata on company servers, he taught himself how to spot red flags, including things such as folders labeled “MISC” or “DEMO.”

But the fraud wasn’t merely fudged numbers on digital ledgers. It was much more than that. And it wasn’t subtle. Companies engaged in egregious behavior, stuff that’s hard to fathom: they concealed drug impurities, used charcoal to bleach yellow pills white, “degraded ingredients behind ceiling tiles” and dumped chemicals into nearby rivers. In these supposedly aseptic facilities, he stumbled across snakes, “nesting sparrows” and two words you’ve never seen paired together: monkey infestations. Groups of companies even “pooled their resources and invested in the same “show” factory, so that different FDA inspectors returned to the same plant at different times, each one thinking they were inspecting a different facility.

In Bottle of Lies, Eban provides a public service, giving readers a behind-the-scenes glimpse into the making of generic drugs, making audible what executives say in private and would never dream of saying in public. One moment captures what I mean: “In a conference call with a dozen company executives, [Dr. Kathy] Spreen expressed her fears about the quality of the AIDS medicine that Ranbaxy was supplying for Africa. One of the company’s top medical executives responded, ‘Who cares? It’s just blacks dying.'” It’s an appalling, sickening answer, but it’s also honest. More infuriating are subsequent press releases after these incidents, reaffirming “values,” “commitments to integrity and quality,” “patient health and well-being” and all the rest. I don’t know about you, but I’ll take disgusting honesty over manufactured insincerity any day. 

The book isn’t an indictment of individuals or a single entity, but an indictment of a bad and bankrupt system, driven by profits to the point where it resembles the clinical pathologies the drugs are supposed to treat themselves; where brand-name prices are divorced from reality and generic companies wring every dollar through shortcut strategies and duplicitous schemes. Patients gain nothing from a system where health has only a tangential relationship to the business model. The larger truth, the larger conflict, though, boils down to medicine’s odd status as a commodity, indistinguishable from other goods like a laptop or convertible. Maybe I’m alone here—maybe this is a crazy, radical statement—but what if public health was imbued with a public purpose as opposed to serving as a vehicle for profit-maximization?

#Bookreview #genericdrugs #China #India #drugmanufacturing #KatherineEban

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