‘Scary World’ of Generic Drug Manufacturing

‘Scary World’ of Generic Drug Manufacturing, Revealed Ellie KincaidJune 2019

All my life, I’ve had problems with different batches of generic drugs, first when I switched from brand name drugs to generic, and then when my pharmacy switched suppliers of the same generic. The “new” pills would have different side effects or different potencies for me, yet the pharmacy always insisted that the medication was “the same”.

I hate being condescended to like this, the “all knowing” pharmacist telling the “silly and confused” patient that she’s imagining things. I’m sure this has happened to countless others too, but now articles like this prove that we were right all along.

In 2008, investigative journalist Katherine Eban started digging into the generic drug industry after hearing stories of patients whose generic drugs were not working properly for them.  

They had been stable on a branded drug, but then relapsed once switched to a generic version or experienced troubling side effectswhen switched between generics. She detailed her findings in a series of articles in the magazines Self and Fortune, and her new book, Bottle of Lies .

The majority of generic drugs are manufactured overseas, and “the [US Food and Drug Administration] FDA was essentially regulating on an honor system,”

Eban told Medscape Medical News. The agency would announce its inspections of overseas manufacturing plants weeks or months in advance, giving companies an opportunity to prepare to put on a good face and mislead inspectors with fabricated data.

Medscape Medical News: What do you think doctors and other healthcare professionals need to know about the state of generic drugs?

Katherine Eban: In the book I feature several doctors from the Cleveland Clinic who struggled with this question of the quality of generics.

A number of heart transplant patients suffered organ rejection after being switched to a generic tacrolimus. And also a number of patients who were followed by a cardiologist who became very intently focused on this question and felt he couldn’t stabilize them on certain generics.

He actually identified drugs that were particularly problematic, and after he identified them, lo and behold, the FDA went into the plants, found egregious conditions, and those drugs were recalled. So he was observing something that really is going on.

What I think physicians need to understand is, if their patient is not responding as anticipated from a medication, they need to consider the possibility that it is the medication that is the problem.

Once doctors become aware of this issue, as their patients have symptoms, or as they have difficulty, I think [doctors] will find that there are certain manufacturers where they have repeated problems, and then when they switch to different manufacturers, everything is OK.

I interviewed this woman who was switched at the pharmacy from a brand name to a generic antidepressant, and had just a horrible set of reactions and side effects.

[She] ended up going from doctor to doctor to try to treat all those side effects because she didn’t realize that it was her generic. She finally went online and began doing her own research and began to connect the dots and realize that the onset of her symptoms was at the point that she was switched to a new medication.

She called her doctor’s office and the nurse at the doctor’s office said, “Yeah, we hear this from a lot of patients.” Had she had that information previously, she would not have been on this horrible medical odyssey.

My impression is that most pharmacists don’t really know about these issues, and that they also don’t really know where drugs are manufactured. It’s not their fault.

What they know is what they have on the shelf at any given time, which is in these big bottles that they’re filling prescriptions from. I think a lot of states don’t even require pharmacies to maintain records of which manufacturer they dispense. The recalls often don’t even get down to the patient level because of that.

One thing that I know a lot of experts in this space really think is important is putting the country of origin, of manufacturing, on dispensing labels.

Why shouldn’t consumers know where the active ingredient and the finished drug are made? Why isn’t that information passed along to patients? That is something that could be a sort of educational tool for everybody in this space.

There was an excellent article about this issue in the New York Times too: Americans Need Generic Drugs. But Can They Trust Them?

3 thoughts on “‘Scary World’ of Generic Drug Manufacturing

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