So I am in a book club. It is all women physicians (different specialties- Pediatrics, Surgery, Family Practice, Internal Medicine, Radiology, OB-Gyne- and settings- PA Clinic, Stanford, private practice, Santa Clara County Medical Center). We read all sorts of nonfiction books, but this time we read one about the generic drug industry called “Bottle of Lies.”
Wow.
Let me start by saying this is an investigative journalism piece, think of it like “The Jungle” (by Upton Sinclair) was for meatpacking plants. What I found interesting is the book was a revelation to ALL of us. Here we are, a group of hyper-educated physicians, and none of us knew how the generic drug industry developed. How are generics made? tested? safeguarded? I have blogged countless times on the herbal industry, and how dangerous it is- many times you are not getting what you think. SEE BLOG HERE.
I thought real medications- generic or not- are FDA regulated and approved. They are different. Tested. Clean. Known.
I am no longer so sure.
For those of you who won’t read the book, (but I highly recommend it. It reads like a fast paced thriller, with lies, subterfuge, and lots of money and market share.) let me summarize some things.
- GENERICS ARE NOT THE SAME AS THE ORIGINAL. This was a shocker. I thought when something went off patent, the “recipe” would be published and everyone could make it. That is not the case. Generic companies have to “reverse engineer” the compound. It means it may have the same stuff in it, but the drug may differ in crucial ways- bioavailability, shelf life, and other issues. Years ago generic companies had to run clinical trials to prove it had the same efficacy as the original. This was expensive, hence few generics existed. That changed, and now generics can do limited studies showing their new drug is similar.
- There are some medications which were tricky to develop. They used the example of Lipitor, which is hard to stabilize. I do not know if the generics were able to solve that.
- There is a race to develop the generic, and the companies first to file get an economic advantage by being able to sell for six months without competition.
- There are many stories of false or distorted studies to prove efficacy.
- THERE ARE MANY GENERIC BRAND COMPANIES. I have heard countless stories of people getting a generic (say cholesterol lowering medication) which every month is a different pill shape or different color. This means they are different generic companies. They will be similar, but as each generic has to reverse engineer the product, it may be different than the original and different from each other.
- THERE ARE QUALITY ISSUES IN GENERICS. This is inflammatory, and for more details you should read the book. But the FDA does not do unannounced drop in visits to foreign pharmacy production sites like in China and India. They know well ahead of time the FDA is coming. There is evidence they clean things up, and hide poor data and production issues.
- This is not only true for generics. https://www.washingtonpost.com/outlook/after-a-scandal-a-one-sided-warning-against-generic-drugs/2019/09/12/6a755e48-c50a-11e9-b5e4-54aa56d5b7ce_story.html
What should you do?
Generics are here to stay. In the effort to keep medicine costs down, there is pressure for generic medicine and it has made medicines more affordable to millions. Generics must work to some extent, as generics for cholesterol, blood pressure, antibiotics,and heart arrhythmias have been in use for a while. But all generics are not created equal.
- GET INFORMED. When you get your medicine, see where it was made. You can look up the plant online to see if it has been flagged for issues.
- GET CONSISTENT MEDICINE. If you find a brand that works for you, request you get that same generic brand again. One woman I know found her medicine could come from a generic in India, Israel, or Ireland. The Israeli one worked well, so she requested her pharmacy only give her that brand.
- IF A MEDICINE “STOPS WORKING” or “DOESN”T WORK” see if another generic or if the brand name works better.
- THERE IS AN ONLINE PHARMACY WHICH TESTS BATCHES to assure the active ingredients are present/no contaminants are in the medicine. https://www.valisure.com
Sure this book is one sided. But the issue is real. I have friends who tell me, “my medicine is no longer working” or “I couldn’t take that medicine as it caused memory issues.” But which medicine was it? Was it the name brand? A generic? WHICH generic?
As physicians, my book club was stunned. None of us had heard of these pervasive issues- just the occasional “bad batch” stories. None of us had understood in detail how generics were developed.
The back cover of Bottle of Lies:
“From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—….. Today, 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists, and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true?
Katherine Eban’s Bottle of Lies exposes the deceit behind generic drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects.”