Editor: Puneet Bhatia
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Investigative journalist Katherine Eban's book 'Bottle of Lies: The Inside Story of the Generic Boom' created a sensation when it release in mid 2019, as it blew the lid off the corruption that has plagued the generic drugs industry. It has been released in India by Juggernaut as 'Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma'.
I got an opportunity to chat with the author and ask her questions about her investigation, the Ranbaxy scandal, her reaction to the criticism in India and where the US Food and Drug Administration, as a regulator, failed to do its job.
Q. Before we start, can you explain to our viewers what generic drugs are?
Ans: So, generic drugs are not supposed to be very different, they are supposed to be bio equivalent, meaning they will work in the body the same way as brand name drugs. So typically, a brand name drug has been innovated or created by a brand-name company and it has been patented. After a certain amount of time that patent lapses, and then a generic company will come in and reverse engineer the brand-name drug which means figure out how it is made in a laboratory. But it is the same molecule and it is supposed to work in the same way in the body.
Q. You've stayed with the story for almost a decade. Tell us how you got involved?
Ans: It began in 2008, I got a phone call from a man in the US who has a radio show about pharmaceuticals. American patients were calling him and complaining to him about side effects from their generic drugs, They were having relapses when they switched from brand named drugs to generics. He thought there was a problem and he brought those problems to the our FDA (US Food and Drug Administration) and they said well it is probably psycho somatic, patients have a negative response when their medicine looks different. So I began reporting what was more like a consumer health story, but as I learned more I switched my attention to markets where a majority of our drugs are made, which is India and China.
40 % of our supply of generics is coming from India. So the US is very dependent upon India and China to supply both active ingredients and finished doses.
Q. A key figure in your book is Dinesh Thakur, a whistleblower who was behind the biggest Ranbaxy expose. Tell us about your investigation into Ranbaxy and Dinesh's role in it.
Ans: For a long time, I had not met him but I knew about Ranbaxy. I knew there was a whistleblower investigation. He was tasked by his boss to figure our if the data in Ranbaxy's regulatory filings globally real or fake and when he finally put together all of this data, he uncovered the fact that more than 200 drug products in more than 40 countries were filed with Ranbaxy with fake data. This was literally a system of fraud that was institutionalized throughout the company to the extent that you had senior executives who were asked to smuggle in samples of 'brand-name' drugs in suitcases and they would use these samples to test and create data that they would pass off as their own.
Q. But before this, your book starts on a very positive note. It starts with Gandhi and Yusuf Hamid of Cipla and how he actually transformed how HIV drugs are distributed and reaching the people who need it the most. There's a very positive side to generic drugs.
Ans: Absolutely, this is really a very heroic chapter in Indian history and in the history of public health. The idea that you could take US taxpayer dollars, that India could make affordable medicine and breakthrough this obstacle course of patents and as part of a global collaboration, we could get life saving drugs to Africa. It was wonderful, it was all good. The problem started after.
Q. The US FDA rules sort of lent them to corruption. There is that chapter where you describe pharmaceutical executives lining up outside FDA just wanting to be the first to get inside the door and it is incredible how patents and licenses were being issued in this manner.
Ans: It is extraordinary. The incentive was called First To File. Basically, what that legislation said was the first company, the very first one to put down an application for a drug in the US with the FTA, if they were approved, they would have six months of exclusivity on the market. Which is essentially the difference between making a living and making a fortune. That was so lucrative, that First To File that when Ranbaxy got it for generic Lipator which is the largest generic launch in the US, they made 600 Million Dollars in 6 months.
So this is big money.
Q. And eventually they had to withdraw the drug from the market
They did. I mean it turned out that it was suffused with glass particles due to a massive manufacturing failure, and it was recalled.
Q. The reaction to your book is coming from a lot of Indian pharma companies is that ‘not everyone’s bad’ and ‘the book focusses so much on the bad that it is not focusing on the good, that it is painting a very negative image of the Indian Pharma industry’ what is your reaction to that?
Ans: You know, I guess I have a few different reactions, first of all the book absolutely showcases the very positive history here and the contributions of Indian Pharma.The heroes of the book are Indian. You know, the people who blew the whistle on this conduct are Indian. Concerned about the health of patients world-wide, concerned about the health of Indians, heroically blowing the whistle at risk to themselves, I did what a journalist must. Which is simply to follow the facts where they led.
Q. One of the facts that led to, the story led to was something that us Indians and other people in developing countries should be extremely concerned about,the book talks about a grading system. Where companies are making certain level of drugs to suit the most stringent regulators in the US and Europe and making another level of drugs for developing countries that slightly lacks regulation.
Ans: So what you are describing actually has a name inside of the industry. It is called Dual Track Production.You know to me, essentially that amounts to a manufacturing standard of whatever you can get away with.We’ll make our best drugs for the more regulated markets and we’ll send our worst drugs that will not pass in any other market, to Africa, and even to India. You know, I think that is really tragic. When I started reporting this project, I just assumed a pill is a pill, if you buy it in Mumbai or you buy it in Memphis. There should be no difference whatsoever. But infact the drugs are different in different markets.
Q. So, there is this conundrum where we can’t afford brand new drugs. What is the solution.
Ans: Good regulation is essential, but I think another part of this is, patient vigilance. So if patients take a drug, they should see who the manufacturer is, they should know and they should think about how they feel are they suffering side-effects and do their symptoms or side-effects seemed changed between prescription changes. Right, I mean those are all clues. That they may be suffering from a substandard generic, so they need to pay attention to that.
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