Generics’ quality is tanking

Generic Problems The Department of Defense is worried about the quality and safety of generic drugs and is in talks to start up a testing program, my colleague Riley Griffin and I reported last week. And we learned through our reporting that Kaiser Permanente, a huge health system, has been quietly having generic drugs tested for the last two years as well. So what does this mean? Why test these less expensive pills and injections that make up 9 out of 10 medications Americans take? Of course, it’s important to understand that the majority of generic drugs are safe. But, increasingly, more of them appear to have issues than might make people uncomfortable. The University of Kentucky started a program in 2019 to test drugs purchased through the college’s network of hospitals and clinics. More than 10% of drugs have been flagged with potential problems, Robert Lodder, a pharmaceutical sciences professor who co-leads the testing effort, told me. This syncs with what the independent testing lab Valisure has said. The New Haven, Connecticut-based company used to run an online pharmacy that it sold in 2021. David Light, chief executive officer of Valisure, said the lab also found issues with about 10% of the drugs. The concerns that cause drugs to fall into the worrisome category can range from the seemingly sci-fi — such as heart and diabetes drugs that contained small amounts of a chemical that can cause cancer — to issues that can sound mundane but actually matter a lot. For instance, how exactly the human body absorbs some drugs has to be precise for the treatments to work. If a medicine isn’t made well, it may not dissolve in a way that allows the body to absorb it correctly. Light says he sees this issue a lot. In past testing, Valisure found multiple batches of the antiseizure drug lamotrigine that didn’t dissolve for at least 24 hours, meaning the body couldn’t absorb them effectively. This can be scary for someone with epilepsy who relies on the drug to regulate their condition. Dissolution issues can lead to a variety of poor patient outcomes that often aren’t pinned on the medication since absorption can’t be seen or felt by the patient. Valisure will now be taking their expertise to the Defense Department if plans for a partnership pan out. I’ll be interested to see what else they find. — Anna Edney