Bottle of Lies: How Poor FDA Oversight & Fraud in Generic Drug Industry Threaten Patients’ Health https://www.democracynow.org/2019/5/20/bottle_of_lies_how_poor_fda Around 90 percent of all prescriptions filled in the U.S. are generic drugs, most of them made in pharmaceutical plants in India and China. The U.S. Food and Drug Administration (FDA) recently said the quality of drug factories in those two countries scored below the world average. Of course, from that, the FDA concluded “the quality of the drug supply has never been higher.” Well, that’s good news. That is the kind of regulation your tax dollars are buying.
After doing some digging, investigative journalist Katherine Eban found some interesting little factoids about generic drugs. The FDA inspects pharmaceutical factories overseas, so everything is fine, right? Well, everything certainly looks fine when the FDA announces its “surprise” inspections overseas up to two months in advance.
Peter Baker was a thirty-two-year-old FDA investigator relocated to New Delhi to inspect Indian factories. He carried out inspections that were not announced ahead of time. His findings were somewhat different from those of other FDA inspectors. Baker found that data fabrication teams come in ahead of FDA inspections to shred and fabricate documents, invent quality data, invent standard operating procedures and so forth. At a company called Wockhardt, he found seventy-five torn batch records indicating that insulin the company was manufacturing was contaminated with metallic particles but nonetheless had been released to patients in India and the Middle East. Baker inspected eighty-six plants in both India and China, and he found at least some data fraud or deception at sixty-seven of those plants.
Baker left the FDA in March 2019. This might have been due to the experiences he had in India. He was followed, threatened and, in one case, poisoned with tainted water at a plant. Some of the investigators that he worked with were spied on. A hotel room was bugged. And based on this sort of experience, he was diagnosed with post-traumatic stress.
Not only are FDA inspections announced two months in advance, but the FDA turns to these same plants to arrange its inspectors’ local travel and hotel ground transportation. What happens is that inspectors are picked up at the airport in a luxury car. They’re taken to a hotel, where their rooms are magically upgraded, and they never get a bill. There are trips to the Taj Mahal, shopping trips, massages and golf outings. The schedule must be grueling.
Whistleblower Dinesh Thakur found that more than two hundred products in over forty countries were filed with falsified data; the company was literally running tests off the brand drug and submitting the results as its own data for the generic version of the drug. He found this kind of information on a Powerpoint presentation shown to a subcommittee of the board of directors. He took this to the FDA.
The FDA did investigate. During the criminal investigation of this company (Ranbaxy) for fraud, the FDA greenlighted Ranbaxy to manufacture the biggest generic drug in U.S. history, the first generic version of Lipitor (the popular cholesterol drug). Millions of doses of Lipitor had to be recalled because one of the ingredients turned out to be glass fragments.
Thakur also found that the quality of drug production is different for the U.S. and European Union compared to the rest of the world. When discussing the poor quality of the company’s AIDS drugs for Africa on a conference call, a Ranbaxy medical director said: “Who cares? It’s just blacks dying.” This gives us some idea of the mentality and ethics of large pharmaceutical companies.
Almost no drug manufacturing takes place in the U.S. because it is much more expensive; and it is easier to bypass environmental regulations in other countries, which companies do. In most cases, there is also less regulation overall.
The interviewer asked Katherine Eban, “What can an individual do?” (besides quit taking drugs you don’t really need, but that’s just me). You usually can’t tell from the label that a drug is generic. The brand name will be there, but there is no information on where the drug was made, which is a problem for generic and non-generic alike. Part of Eban’s response was, “Well, I do take generic drugs. Of course, we all take generic drugs.” Uh no, “we” don’t, but the number of Americans taking some kind of drug is so high I won’t quibble over a few percentage points. This video is not very strong on solutions, but it gives us more good reasons to stay away from drugs as much as possible. The thumb is UP.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Fall 2019