What’s In That Prescription Medicine Bottle?

Jeffrey Billman
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3
Mar
21
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“Before I embarked on this project,” the investigative journalist Katherine Eban writes in her 2019 book, Bottle of Lies: The Inside Story of the Generic Drug Boom, “I had always assumed that a drug was a drug.”

She was wrong.

Generic drugs—“bioequivalents” of brand-name drugs sold at significantly lower prices—have saved millions of lives across the globe and become ubiquitous in the United States. Indeed, nine of every 10 prescriptions dispensed in the U.S. is a generic. Quite literally, we can’t live without them.

But as Eban discovered, you don’t always get what you pay for.

In a narrow sense, Bottle of Lies tells the story of Ranbaxy Laboratories Ltd., an Indian generic drug manufacturer that pleaded guilty to seven federal criminal charges as part of a record $500 million settlement in 2013. For years, the company had falsified data to push adulterated drugs on the American market. Had an insider not blown the whistle to the U.S. Food and Drug Administration, Ranbaxy’s deception would likely have gone unnoticed.

But Ranbaxy’s fraud was the rule, not the exception, Eban says. And nothing changed with its guilty plea.

Bottle of Lies offers a disturbing window into the generic drug industry in India (and, to a lesser degree, China), where the pressure to generate profits by any means necessary is matched only by the FDA’s fecklessness. This perfect storm of globalization, avarice, and lax regulation has given rise to what Eban calls both “the world’s greatest public health innovation” and “one of its greatest swindles.”

Drawing on a decade of reporting, Eban—a Vanity Fair contributor who has previously investigated CIA interrogations, gun trafficking, and counterfeit pharmaceuticals—crafts a narrative that grows more infuriating by the page. It’s a systemic indictment warning us that the pills we take might not be what we think they are.

Eban spoke via Google Meet with Jeffrey Billman from her home in Brooklyn, NY. Their conversation has been condensed and edited for clarity.

NPLB: The generic industry took off in India because plants there produced cheap drugs. What were the most common problems you found in those facilities?

Eban: The biggest problem that Bottle of Lies focuses on is fraud, which is that these companies are either manipulating or inventing quality data to present to regulators to make it appear as though they have a perfect product to get approval. But the truth underneath that faked data is that the drugs are not bioequivalent, have impurities, have toxic particulate matter, carcinogens—[and] the FDA is essentially closing its eyes to because it has been announcing its inspections [of overseas facilities] in advance, maybe months in advance.

I should add that right now, [regulation is] even worse because overseas inspections have been suspended [due to] COVID. So the FDA is almost entirely relying on data from these plants. And we know what the data is like.

NPLB: Like you, I’d assumed generics were copies of brand-name drugs.

Eban: Many consumers think there is this peaceful transfer of intellectual property once a [brand name] patent lapses, as opposed to the reality of generic drug makers going into a lab with their samples of the brand-name drug and reverse engineering it and trying to come up with their best guess of how to make it.

To get a new brand drug approved, the drug maker has to prove safety and efficacy to the FDA. To do that, they have to have really broad clinical trials with sometimes thousands of patients and reams of data. But when you’re talking about a generic that has the same underlying molecule, the FDA’s position is that safety and efficacy have already been proven. The burden on the generic company is to prove bioequivalence, which is the same absorption into the blood. But the rate of absorption is not part of that equation. So you have cases where generics have been approved that dumped the drug into the bloodstream very swiftly as opposed to a slow release, and the experience for patients can be quite debilitating.

NPLB: How often do bad drugs actually make it to the market?

Eban: I think it’s fairly common. I get emails every single day from patients who are just at the end of their rope, they don’t know who to turn to for help. Their drugs don’t work. This can lead to all kinds of consequences—hospitalizations, suicides. In the book, I focus on these Cleveland Clinic cardiologists who realized that their heart transplant patients were suffering organ rejection when they were switched to an Indian-made immunosuppressant.

NPLB: And doctors tend to write off patients’ complaints as psychosomatic?

Eban: When I’ve talked to doctors and pharmacists about these [cases], I’ve had so many of them come up to me and say, “I just thought my patient was a whiner and a complainer.”

NPLB: The book talks about the Indian culture of jugaad. Could you describe what that means?

Eban: It’s essentially the art of the shortcut. Indian life is really onerous and highly bureaucratic, and a corporate culture has developed where the ability to navigate around obstacles is really prized. The problem is when these regulations that can mean the difference between life and death are viewed as the obstacles that one is going to navigate around.

My investigation showed that this is really a prevalent view. In the book, I feature an FDA investigator named Peter Baker, who inspected, I think, 86 plants in India and China over four years and found evidence of fraud in four-fifths of them.

NPLB: The FDA had to notify overseas facilities about inspections weeks in advance, and inspectors often seemed manipulated. There was a period after the Ranbaxy settlement when the FDA seemed to toughen its stance. But a few years later, it backed off. What happened?  

Eban: We have very serious drug shortages in this country. The problem is that serious inspections and serious compliance and serious enforcement, all of which are absolutely essential to protect consumers, can exacerbate drug shortages. If you’re going to sanction a plant that is not complying with good manufacturing practices, you’re going to restrict it from operating, and you’re going to reduce the flow of those low-cost drugs into the U.S.

But at the same time, the FDA is going to Congress and saying, “Look at how many low-cost drugs were brought into this country. We are on the side of right.”

NPLB: So Congress is pressuring the FDA to import more low-cost drugs, and that’s at cross purposes with a regulatory regime that insists on perfection?

Eban: Right. The FDA is not being fundamentally straight with the American people as to what the real risks of these drugs are.


"There are manufacturers I avoid. I keep that little list in my head."

NPLB: The Serum Institute of India, the largest vaccine manufacturer in the world, is helping manufacture AstraZeneca’s COVID vaccine. Would you take a vaccine made there?

Eban: I’d never take that. Not in a million years if it was being made by The Serum Institute.

[Note: On Feb. 15, the World Health Organization approved the AstraZeneca vaccine manufactured at The Serum Institute for the United Nations’ vaccine program for low- and middle-income nations. The AstraZeneca vaccine intended for Americans arms, which will probably be approved in April, is being manufactured in Baltimore.]

NPLB: I found this disturbing: You reported that Indian pharma companies shipped lower-quality drugs to the developing world, where there aren’t sophisticated regulatory regimes, than to the developed world. So drugs sent to Africa might be inert or adulterated.

Eban: I just assumed that a drug was a drug. If you get generic Lipitor anywhere in the world—you’re in Portugal, you’re in India, you’re in Timbuktu, you’re in the U.S.—you’ve gotten generic Lipitor. To understand suddenly that there’s wild quality variation, that there’s a generic Lipitor on planet Earth that bears no relationship to something called generic Lipitor on another part of planet Earth, was kind of mind-boggling for me.

NPLB: The ramifications for antibiotics are frightening.

You have these sub-potent antibiotics that are being sold around the world that are driving drug resistance. So even if you’re sitting in your nice house in the U.S. and saying well, who cares, it’s affecting you.

NPLB: Are we any closer to ending this practice?

Eban: There has been discussion now for quite a long time about creating some kind of global treaty that would define drug quality. It was high on the global agenda—and then COVID hit.

NPLB: Right now, 90 percent of drugs dispensed in the U.S. are generics, and they account for just 22 percent of prescription spending. The system runs on cheap drugs. Would quality make it unsustainable?

Eban: I believe there is a hidden cost to these cheap drugs—in hospitalizations, re-admissions, stabilized patients who become unstable. But the problem is that cost has not been assessed. Insurance companies don’t have a number for that. So we need to understand what the costs are in order to solve it. Attached to that idea is that we have to incentivize quality. What is the incentive for drug makers to make a higher-quality and possibly higher-cost drug? Are they getting rewarded in the marketplace? No, because nobody’s measuring the quality.

NPLB: You wanted Bottle of Lies to help people “make informed choices.” When I fill a generic prescription, no one asks which manufacturer’s version I want. How do we know if we’re getting a quality product?

Eban: This is the question I’ve been asked the most, and this is why I put together on my website a guide to investigating your own drugs. It’s my effort to get a little bit of power into the hands of consumers—but not much, because there’s not much that consumers can do. You could read a book like Fast Food Nation and be like, “God, this is terrible. I am never going to eat factory-farmed meat again.” And you have labeling that can help you to make those choices.  

But that does not presently exist for [drug] consumers. There is no Yelp guide, no Zagat guide to quality for these manufacturers. We’re all led to believe that the quality is the same because once the FDA approves it, it’s all good.

So what are consumers to do? The number one thing they need to do is know who’s making their drug. Because if it works, they want to stay on it. If it doesn’t work, they want to switch. You can’t do any of that unless you know who’s actually making the drug.

What’s needed here is a consumer revolution—the kind of revolution that has now led to you walking into Whole Foods Market and you see that your apple was flown 575 miles from wherever. That’s what we need. We need transparency. We need information.

NPLB: Is this the kind of thing where people should trash their medicine cabinet?

Eban: When I was selling the book, I was speaking with different editors at different publishing houses, and I had a conversation with a guy where I could hear the sound of plunking into the garbage can. As we were talking, he was going through his desk drawer tossing bottles.

NPLB: Are there generic manufacturers whose drugs you won't take?

Eban: There are manufacturers I avoid. I keep that little list in my head.

NPLB: Let me ask a different way. Are there generic manufacturers with good reputations?

Eban: There are companies that seem to have better track records. None of these companies is perfect. But then, there are a lot of brand companies that have set up manufacturing plants in India and have no idea what’s going on in their own plants.

NPLB: In the paperback edition’s postscript, which you wrote in December 2019, you wrote that we were “closer than ever to real reform.” Do you still think that’s true?

Eban: We are closest to a real reshoring movement, which is the rebuilding of [pharmaceutical] manufacturing sector capacity. That is a real bipartisan goal, and COVID has helped underscore why that’s so important.

There are models for how to do this. You might be looking at a somewhat increased cost, but the savings would be in reliability and quality. I suspect we may see some real movement around that.

Unfortunately, there’s always more momentum right after a big scandal, so we might be a scandal away.

Jeffrey Billman is an award-winning investigative journalist based in North Carolina.

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