Two years ago, the prime minister of India said that doctors should prescribe generic drugs for Indian patients. How do you see the quality affecting patients in India? How is it any different when it comes to US patients?
My book exposes how a number of generic drug companies routinely alter their manufacturing standards and the quality of their drugs, depending on the vigilance of regulators in the markets to which they are selling. They sell drugs of lower quality in less regulated markets, which includes India.
The practice is so widespread that it has a name: dual-track production. This is not just a question of companies following different standards, based on those set by a country’s regulators, but rather flouting standards with impunity in making drugs with lower-quality ingredients and fewer manufacturing steps, or simply fabricating testing data.
That is bad news for patients in India, where some companies do not even feel compelled to actually test drugs or submit authentic data for Indian regulators. The result is a drug supply of very uneven quality, where the safety and efficacy of each dose is far from guaranteed.
When it comes to medical devices, too, questions have been raised on the ways in which FDA assessments might be compromised, endangering the safety of patients. What changes do you think the FDA should bring about to ensure quality?
The problem now is that the FDA is regulating overseas drug plants largely on an honour system. It is reviewing data submitted by companies, and conducting inspections after giving the manufacturing plants weeks of advanced notice that its investigators will be arriving. That allows the plants to stage inspections and create a façade of compliance. Plants will invent data, fabricate documents, conceal offline equipment and clean up lizard and bird infestations.
The FDA’s top officials like to talk about promoting a culture of compliance, in which companies willingly raise their own standards. But that simply doesn’t happen without the threat of regular, unannounced inspections that require compliance 24/7.
How has the FDA responded to the serious allegations in your book?
The FDA’s position has long been, and continues to be, that it has an effective inspection and oversight system. However, the US Congress has grown sceptical of these claims, and appears to be gearing up to do some real oversight, which, of course, is its designated role. In June, a month after the release of Bottle of Lies, a Congressional committee sent a letter to the FDA, asking questions about its regulation of overseas drug plants.
How long did you work on the project? Could you recall a particularly challenging moment during your investigation?
I reported on the generic drug industry for a decade, with the last five years specifically spent on the book. Along the way, there were numerous challenges. The first came early on, essentially with the premise of the project.
My reporting began in 2008, when I was contacted by the co-host of a US radio show, The People’s Pharmacy. He said that patients were contacting him with complaints about side-effects from their generic drugs, and he posed a question to investigate: what is wrong with the drugs? It quickly became apparent to me that just documenting patient concerns would not get me very far in answering that question. I realised the answers most likely lay in the manufacturing plants and boardrooms of the companies making our drugs, which meant in India and China. So that was the first challenge: how was I, an independent journalist without a newsroom, a team of colleagues or other resources at my disposal, going to undertake a project like that? The answer was: with great difficulty.
The other challenges along the way stemmed from that initial one. Warned of safety risks in India, I tried to meet sources only in public places. In China, I was followed by government security officials, who, in one instance, commandeered the home screen of my iPhone to send me a message that I was being watched: a picture of a security official seated in my hotel lobby, holding up an English language newspaper. I met a reluctant whistleblower from one company in a bar in Mexico City, and he ultimately gave me important documents. The reporting was like that: global in scope, painstaking, and trying to convince one source at a time to cooperate and share information.
In the run-up to publication, the threats were legal ones, from companies who were trying to intimidate me and my American publisher into not including all the information we had. But in the end, I am happy to say, the book and the truth won out.
The world, including the US, needs more generic drugs that are safe, cheap and accessible. At this point, what do you think are the biggest hindrances in making that possible?
To some extent, the pathway to affordability is clear. The model, used during the height of the AIDS crisis, is for governments to unite in aggregating purchases, so that low-cost manufacturers can achieve sales in large volume. The problem is really with how we can guarantee quality when companies are willfully undercutting their own products in order to increase profits.
The big purchasers—The Global Fund to Fight AIDS, Tuberculosis and Malaria and The President's Emergency Plan For AIDS Relief—must provide stronger incentives for quality, while regulators must increase their vigilance. Regular unannounced inspections at manufacturing plants, coupled with routine surveillance testing of drugs on the market, are required to ensure compliance.
Besides drugs safety, do you think patents are also a big issue when it comes to developing countries having access to generics?
Bottle of Lies does not delve into the patent issues so much, but they certainly can be a barrier. History offers one model for how to overcome that problem, in extreme circumstances. During the height of the AIDS crisis, so much public pressure was brought to bear on big pharma companies that they were forced to waive their patents so that generic drugs companies like Cipla could step in to manufacture the AIDS cocktail. As the multinational companies expand into the generic sector, I would like to think that, in the future, patents will serve as less of a barrier.