Questioning the Safety of Generic Drugs

Information in this space is normally drawn from multiple sources; however, after reading Bottle of Lies by Katherine Eban I decided to make an exception. The book examines the increase in our dependence on generic drugs — a trend that has grown since the turn of this century. The author started her investigation into these drugs in 2008 following a prompt from pharmacologist Joe Graedon of the independent watchdog group The People’s Pharmacy. He reached out due to the large number of complaints about generics from the people who read his column or listened to his radio broadcasts. Their main concern with generics was lack of drug efficacy.

Eban is an investigative journalist and the material for her book was gathered from whistleblowers, regulators and confidential U.S. Food and Drug Administration (FDA) documents. Her findings proved stunning. The book’s premise is that the lack of efficacy cited by Graedon can often be traced to the manufacturing process and lack of FDA oversight for drugs made overseas. According to Eban, 80% of all active ingredients in the generic drugs distributed in the United States are made in India or China, where the FDA’s presence is both infrequent and restricted.

In many cases, this lack of efficacy is due to inadequate amounts of the active ingredient. This has lead to numerous problems, ranging from death to the creation of resistant bacterial strains. Some ingredients can be particularly harmful. One blood pressure medication, for example, was found to contain n-nitroso-n-methyl-4-aminobutyric acid — a known carcinogen.

IN MANY CASES, THIS LACK OF EFFICACY IS DUE TO INADEQUATE AMOUNTS OF THE ACT

Eban’s investigations turned up numerous activities on the part of some drug manufacturers to circumvent FDA regulations and inspections; these include im­proper testing and concealing or altering data. She attributes this to a lack of unannounced FDA on-site inspections of overseas plants. In contradistinction, the FDA can inspect anywhere in the U.S. without notice. Yet when visiting overseas plants, FDA inspectors are often required to schedule their visits weeks or months in advance. This has allowed some companies to circumvent U.S. regulations.

On the positive side, the greatly reduced price of generic drugs has undoubtedly saved millions of lives, and wholesale condemnation is not appropriate. By the same token, due diligence is certainly warranted on the part of professionals and patients.

Concerned by potential issues with generics, I took a list of my medications to my pharmacy and asked what company made the drugs and where they were manufactured. I was given the names of the drug companies, but was told the pharmacist did not know where the drugs were made. An online search revealed they were all made in a country frequently cited in the book as having problems — and one of my meds was made by a company listed as a primary offender.

Consequently, I have switched to nongeneric medications and am providing educational materials on the topic to my patients.

What will you do with this information?

Thomas G. Wilson Jr., DDS
Editor in Chief
twilson@belmontpublications.com

From Decisions in Dentistry. January 2020;6(1):6.