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Pharmaceutical insiders reveal dangers of some generic drugs

Investigative journalists have been writing about problems with generic drugs for years. One example we recommend is Katherine Eban’s 2019 book “Bottle of Lies: The Inside Story of the Generic Drug Boom.” It blows the whistle on fraud and lax Food and Drug Administration oversight.

Bloomberg News health care reporter Anna Edney has written scathing articles about quality problems with generic drugs. ProPublica journalists Debbie Cenziper and Megan Rose have also blown the whistle on the FDA’s slipshod oversight of a giant Indian pharmaceutical firm.

What puzzles us is that even with all these revelations, few physicians or pharmacists are raising questions about the generic drugs they are prescribing and dispensing. Their professional organizations have remained disappointingly silent.

Perhaps health professionals will be more open to stories from insiders. Here is a sampling from readers offering inside perspectives from their own experience:

“As a pharmacist and consumer, I am beyond concerned about tainted or contaminated drugs coming from India, China and elsewhere. We are not being protected by the very governmental agency that is assigned to do so. Perhaps it is time to re-evaluate the role of the FDA. Maybe they are part of the problem.

“Drugs for American consumers should be manufactured in the United States under careful oversight. The source of the raw ingredients from which these drugs are manufactured needs to be more highly scrutinized.”

Another pharmacist has a similar take: “As a doctorate degree pharmacist with 43 years of clinical experience, I am horrified by the current state of the pharmaceutical industry. Back when I was working, pharmaceutical and biotech companies were based in the U.S. and manufactured their drugs here.

“I have also taught pharmacology to nursing students and oncology fellows, managed a compounding pharmacy and served as a clinical pharmacist in a primary care setting.

“We’ve sold our souls and mortgaged our health to companies that value profits over patient safety. I have seen many problems with generic drugs, especially with narrow therapeutic index drugs. Those include some anticonvulsants, certain blood thinners and a few thyroid medications as well.

“It’s absolutely terrifying what patients are being exposed to unknowingly. As a health care professional, there are not many ways to assess the safety of these drugs except through trust in the FDA, which has become laughable. This is a huge scandal that has been allowed to go unchecked for at least two decades.”

Here is a shocking story from a different reader: “I was a quality assurance inspector for a pharmaceutical company that ordered diphenhydramine from abroad. That ingredient was trashy with what looked like a lot of floor sweepings and black blobs of something I could not identify.

I rejected all of that ingredient. The next day, the boss told me that he had authorized the release of that ingredient to be used in production!

“When I left work later that day, I contacted the FDA and reported the whole mess. I don’t know if the FDA acted on my complaint, but I quit my job before the weekend.”

This is just a sample of messages we have received from insiders. We hope they will inspire physicians, pharmacists and other health care professionals to demand better oversight of our generic drug supply.

In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of King Features, 300 W. 57th Street, 41st Floor, New York, NY 10019, or email them via their website: www.PeoplesPharmacy.com. Their newest book is “Top Screwups Doctors Make and How to Avoid Them.”

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