Thread by @KatherineEban

Friends, my book Bottle of Lies: The Inside Story of the Generic Drug Boom comes out today. When this journey began 10 yrs ago, I never thought it would lead me to expose egregious fraud in overseas generic drug plants we rely on. Looking back, here are a few key moments (thread)

2) My journey began in 2008 w/ a phone call from @JoeGraedon, co-host of @NPR’s @PeoplesPharmacy. His inbox was flooded w/ patients getting sick after being switched from brand-name to generic Rx. My scribbled notes held a question: what is wrong w/ the drugs?

3) My first story in @SELFmagazine described patient/MD struggles w/ generic Rx. Then-prez of @APAPsychiatric told me: “The FDA is satisfied that generics are ok. My question is, `Are we satisfied?’”

4) I still had unanswered questions. What was wrong w/ the drugs and why? An anonymous tip from a mysterious source – “4 Dollar Refill” - redirected me to look overseas.

5) Now, a few brief stats: 90% of our #drugsupply is generic. Nearly 40% of those drugs come from India. 80% of active ingredients in all our Rx come from overseas, vast majority India and China.

6) Digging deeper, I learned about Ranbaxy, then India’s largest Rx co. It was being investigated by @US_FDA for falsifying quality data. Inside, chaos reigned. Fistfights in boardroom. Chain-smoking executives. Drug ingredients stashed in employee fridge, next to Half-and-Half.

7) More telling was a shocking disregard for human life, from some company executives. When discussing the poor quality of the company’s AIDS drugs for Africa, on a conference call, a Ranbaxy medical director said:

8) Then, I got my hands on a smoking gun – an internal PPT presented to a subcommittee of board of directors. The top executives knew, and did not stop, a massive quality-data falsification scheme. Here’s one slide from that PPT:

9) The @US_FDA also had this document. But 5 years into investigating Ranbaxy, it still asked the company for permission to come and inspect its facilities overseas, w/ 2 months advanced notice and requested help arranging hotel and local travel. Just like this:

10) In May 2013, “Dirty Medicine,” my 10,000 word article about Ranbaxy’s fraudulent data scheme, and the whistleblower @d_s_thakur who bravely exposed it, ran on @FortuneMagazine ’s US website.

11) But still, I wanted to know: was Ranbaxy an outlier – or tip of iceberg? A new source contacted me, just as the book project began.

12) Suspicions had long lingered around generic drugs manufactured overseas. A compliant manufacturing plant usually discards a certain % of drug batches. But in India, @US_FDA’s investigators rarely saw a rejected batch.

13) Around 5 yrs before taking top @US_FDA job, @ScottGottliebMD recounted to me the struggle to secure quality of @PEPFAR drugs for Africa:

14) As it turned out, Ranbaxy was tip of the iceberg. With the help of multiple corporate whistleblowers, 20,000 internal FDA documents, and reporting on four continents, I learned that a culture of fraud permeated the industry.

15) From 2012-2016, @US_FDA investigator Peter Baker found fraud/deceitful data practices in 67 of 86 drug plants he inspected in India and China.

16) Companies were using hidden laboratories, secretly repeated tests and altered results, and submitting fake quality data to regulators to gain market approval. Here’s one such hidden lab in a drug plant in Mohali, the door blocked by a bulky appliance:

17) And here’s the inside, where the company was performing secret offline tests, to try and game the results in official tests.

18) Drugs with toxic impurities, unapproved ingredients, dangerous particulates, or that are not bioequivalent to brand, have reached US patients, including this live bug entombed in a @drreddys high-blood pressure capsule, which reached a NJ retiree.

19) .@US_FDA investigators have found bird/insect infestations, toilets w/ no drainage piping (urine on floor), lizards. At one FDA-regulated drug plant in India, inspectors found this fella, perched above a computer monitor.

20) The @US_FDA likes to talk about #s: inspections up; warning letters up. But there are #s they don’t talk about: the downgrades of its own investigators’ most serious findings at overseas drug plants (from Official Action Indicated to Voluntary Action Indicated.)

21) From 2013-2018, FDA downgraded roughly 110 Indian drug plants from OAI to VAI. Same time period for US drug plants? 1 downgrade. Why? @EnergyCommerce

22) Sometimes @US_FDA downgraded + sent nonpublic “untitled letters” b/c it waited too long to act. Check out this year-long delay & resulting downgrade for non-compliant Indian plant (UL=untitled letter). Result: US patients end up getting drugs made w/ dubious data.

23) Unanswered questions drove me to this investigation: 10 years, reporting on 4 continents, 240+ interviews; 20,000+ confidential FDA docs. The book is on Amazon here: amzn.to/30eP8To, or @HarperCollins, @eccobooks here: bit.ly/2WxMlCI. Happy reading!