A Dose of Reality About Generic Drugs: Katherine Eban (Transcript)

Katherine Eban at TEDMED conference

Full text of journalist Katherine Eban’s talk titled “A dose of reality about generic drugs” at TEDMED conference.

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Katherine Eban – Journalist

In 2008, I got an unusual phone call from a guy named Joe Graydon. Joe said he was getting flooded with complaints from patients who’d recently been switched to generic drugs. Joe was a trained pharmacologist and co-host of a radio show on NPR.

Patient after patient said their generics were causing unwelcome side effects or even relapses. Joe believed the patients’ claims.

But when he reported these complaints to the FDA, officials there argued, it was probably psychosomatic. Patients are upset by pills that look different from their old ones. Joe didn’t buy it. He wanted someone with investigative firepower to dig into this.

And since I was an investigative journalist, he called me.

And then he posed a question that I couldn’t get out of my head, “Katherine, what is wrong with the drugs.”

I spent the next 10 years trying to track down the answer. Our healthcare system relies on generics. My family does too.

But a decade of interviews, meetings with whistleblowers, on the ground reporting across four continents, and thousands of confidential files from the FDA, from generic drug companies and from the courts, all pointed me in the same direction: a large number of generic drug manufacturers in certain overseas countries are passing off substandard drugs as legitimate generics for profit.

They are deliberately flouting FDA regulations and standards. Basically they are committing fraud. In the process they are risking the health of patients around the world. They may even be costing patient lives.

One leading company in India has already shut down because of this activity. I wanted to know: was that company an outlier or the tip of the iceberg?

What I uncovered is disquieting and anyone who takes generic drugs has the right to be deeply concerned. If you’re skeptical about any of this, that’s fair. I saw generics as one of the world’s great public health innovations, a giant win for patients worldwide. 90% of our drugs today are generic. I knew generic HIV AIDS medicine had saved many lives in Africa. Here at home, programs from Medicare to Medicaid and the Affordable Care Act depended on them.

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In an overpriced drug market, generics were the heroic underdog. But my biggest assumption was based on the FDA’s reassurance that properly regulated generic drugs are not only safe and effective, but bio-equivalent – interchangeable with the brand and with one another.

Well that’s true, if companies follow the rules on paper. But inside far-flung drug plants, I uncovered a different unwritten set of rules.

I started my investigation by focusing on the regulatory framework. Right away, one fact surprised me. The FDA does not vet manufacturer applications by testing the drugs. Instead it reviews company data. As the FDA’s generic drugs director actually told me: “The approval system requires the ethical behavior of the applicant. Otherwise, the whole house of cards will fall down.”

Really? It’s the honor system?

After nine months of digging, I published my first article on generics. I wrote about patients who’d been switched to generic drugs and suffered medical setbacks. I quoted doctors who questioned whether generics really were bio-equivalent to the brand.

A month later, I got an anonymous email from someone calling himself $4 refill. $4 is what you’d pay to fill a generic prescription at Walmart. $4 refill worked inside the generic drug industry. He said, if I really wanted to uncover the problem, I’d better go look where the majority of our generic drugs are made: in India and China.

$4 refill was right. 80% of the plants making the active ingredient for all our drugs, brand or generic, are overseas, mostly in China and India.

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