Full text of journalist Katherine Eban’s talk titled “A dose of reality about generic drugs” at TEDMED conference.
Listen to the MP3 Audio here:
TRANSCRIPT:
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.
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?
[read more]
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.
Any generic drug company, anywhere in the world, wanting approval to sell its drugs into our market has to follow a lab-written rules known as good manufacturing practices. I decided to learn every detail of how to manufacture a legitimate generic drug. At a top New Jersey lab, I watched as technicians ran tests on specialized machines and used flasks that mimic stomach conditions to measure drug disillusion.
But one remarkable fact jumped out. The lab banned Wite-Out correction fluid across its facility. Under FDA Rules, data serves as the cornerstone of quality. It has to be gathered at each manufacturing step preserved and shared with regulators.
Wite-Out was high risk. It invited tampering. It was clear that for the FDA’s regulatory regime to succeed, any company applying for approval had to be ethical and its data had to be unaltered.
But what if neither was true? What if the applicant was not ethical? What if the data was not pristine?
I started to hear about a company in India called Ranbaxy, India’s largest drug company, one of its first successful multinationals, and one of the fastest growing generic suppliers to the US market. A whistleblower was supplying internal Ranbaxy documents to the FDA. I got copies.
Deciphering the company’s charts, graphs, and numbers unveiled a shocking swindle. They substituted unapproved, lower purity ingredients. They invented documents like standard operating procedures, steaming them overnight in a sauna like room to make them look old. They conjured up three, six, nine, and eighteen months stability studies, all generated on the same day.
Gradually, I was able to unearth the story behind this regulatory nightmare. In 2004, Ranbaxy hired a new research and development director. He suspected something was amiss. He ordered a young engineer named Dinesh Thakur to study the data in every drug application to find out if it was real or fake.
Thakur eventually put together a devastating PowerPoint showing Ranbaxy had falsified data for over 200 products in more than 40 countries. New R&D director showed this PowerPoint was subcommittee of the board of directors. The subcommittee ordered the report and the laptop on which it was created, destroyed. Then they forced Thakur out of the company.
Thakur couldn’t sleep thinking about Ranbaxy’s perilously bad drugs.