World needs generic drugs but their quality must be guaranteed: Journalist Katherine Eban
Eban discusses her findings and how regulators and countries need to step up to protect patients.
In her new book Bottle of Lies: The Inside Story of the Generic Drug Boom, New York-based investigative journalist Katherine Eban highlights malpractices among generic drug makers in India and China, which dominate the segment, the shortcomings of regulators in checking these and the threat this ultimately poses to patients. In an email interview with ET, Eban discusses her findings and how regulators and countries need to step up to protect patients. Edited excerpts:
Your book is a damning indictment of generic drug manufacturers in India and China, with countless examples of fraud and corruption. In the course of your investigation, what was the most shocking revelation?
I reported on the generic drug industry for 10 years, five spent exclusively on Bottle of Lies. In all my reporting, two examples stick in my mind. One was of a plant in India that had perfect data showing that it was sterile. Microbial limits testing, bacterial endotoxin testing — all the samples had perfect results.
Yet the samples didn’t exist. They were testing nothing. The entire laboratory was a fake, which an FDA investigator uncovered during an unannounced inspection. This deception, to me, was really a shock. If they would fake their own sterility data, what wouldn’t they fake? And then, there was an incident in which a Ranbaxy executive was on a conference call with the company’s medical directors, and she raised concerns about the quality of the AIDS drugs Ranbaxy was making for Africa. One of the company’s medical directors said on the call, ‘Who cares. It’s just blacks dying.’ This, to me, was a chilling anecdote about a company that had come to value profits over human lives.
There are people quoted in your book saying they have stopped taking generic drugs, after they became aware of malpractices. But with prices of branded drugs soaring, what should be the ideal way forward?
The world needs generic drugs. They are indispensable. But their quality must be guaranteed. They are not a bargain if they don’t work properly, as one of my sources likes to say. At the moment, unfortunately, patients must become detectives and figure out: What company is making their drugs? What is the regulatory track record of that company? Do switches in manufacturers create side effects or relapses? Ideally, the manufacturing country of origin, for both the active ingredients and finished formulation, should be on the dispensing label. For that to happen, we need new laws. And it is critical that governments move beyond a regulatory honour system, relying on pre-announced inspections and company-generated data. Governments need to conduct unannounced inspections and randomly test the quality of drugs in an ongoing surveillance system. Finally, the world’s regulators need to come together and help hammer out international laws that clearly define acceptable standards for drug quality and enforce strict penalties for negligence or deliberate deception.
Former FDA head Scott Gottlieb recently tweeted that he has ‘extreme confidence’ in generic drugs. Have there been improvements in the sector in the last few years?
I would like to agree with his statement. But I don’t. Currently, the FDA is giving overseas generic drug plants weeks, if not months, of advance notice that investigators are coming. Those same plants are arranging local travel and hotel accommodations for FDA investigators, providing luxury cars and upgraded hotel rooms. The result is what one of my sources called ‘regulatory tourism’. In some instances where the FDA’s own investigators have found strong evidence of fraud, FDA officials have downgraded recommended penalties against the plants. Some FDA investigators and regulators I interviewed specified that they would not take low-cost generics from many of the plants in India and China that they inspected.
Your book emphasises the risks to the health of the American consumer. What’s at stake for Indian patients?
Unfortunately, the picture is far worse for the Indian consumer. Generic drug companies routinely make drugs of lower quality for less regulated markets. The practice is so widespread that it goes by different names: dual-track, multi-tier or row A/row B production. The companies send their worst (and most cheaply made) drugs to markets with less vigilant regulators, who are unlikely to detect the poor quality. One of those markets is India. The glut of substandard generics in developing markets has a profound public health impact, not just on patients who take them, but on everyone. Increasingly, researchers believe that while substandard drugs do not contain enough active ingredients to effectively cure sick patients, they can contain enough to kill off the weakest microbes while leaving the strongest intact. These surviving microbes go on to reproduce, fuelling a growing epidemic of drug resistance worldwide.
Are better oversight by regulators and stricter enforcement of regulations at the heart of a solution?
The world needs a unified system of drug regulation across markets that prioritises both low cost and high quality. The model for this is the aviation industry which, through a body of international laws, has stipulated basic safety provisions and strict consequences for failing to meet them. Basic tenets of drug safety must include unannounced inspections of drug plants in every market, as well as surveillance testing of drugs already in the market. Regulators need training, and must view themselves as working for patients, not companies. And patients need transparency, with clear information about who made their drugs and drug ingredients, and where they were manufactured.