Generic drugs can save you money, but some could also make you very sick.
A new Ohio State University study found that manufacturing differences between the U.S. and other countries, mainly India, can lead to lower quality drugs.
The study is published in the journal Production and Operations Management.
John Gray is the study’s co-author and professor of operations at the OSU Fisher College of Business.
Debbie Holmes: You were able to identify the origin of generic drugs, the country where they were made. That was a big part of your work analyzing drugs, and it's something the FDA would not release to you. How did you find out where the drugs came from?
John Gray: That was a fairly complicated task. There's a website called DailyMed.gov, and on that website they have detailed labels, not like the labels you see on the drug, but like a big PDF file that describes a lot about the drug. And in many of those labels, most of those labels, we were able to scrape the location. It's actually just a manufacturer identifier. We had more work to do after that to link that identifier to the actual plant. But it was basically through DailyMed and then Dun & Bradstreet's database. It took months of work. It's not the actual address of the location. It's a long number. And then we had to go to that database to find the actual facility.
Debbie Holmes: How many countries make drugs generically that are sold at our pharmacies? And what is the percentage of generic drugs sold in this country that are made outside the U.S.?
John Gray: So based on our data, it's about 50% made in emerging economies, which are (part of) our original study, and maybe about 60 or 70 outside of the U.S. And probably about 20 or 30 countries were in our database. But the vast majority were (in the) U.S. and India. So about half of the drugs, of the generic drugs that we buy, are made in emerging economies. And the vast majority of those are made in India. And then the other half are made in the United States or Europe or Canada or other advanced economies.
Debbie Holmes: Explain the study and how you examined these drugs.
John Gray: Yeah, so real strength of the study is that we exactly matched drugs based on active pharmaceutical ingredient dosage form and route of administration. And we only included in our study drugs that were made both in India and in the U.S. And then we compared those drugs controlling for volume and other factors on the number of severe adverse events that they were implicated in.
Debbie Holmes: And what kind of severe events are we talking about?
John Gray: Hospitalizations, disability, death, etc.
Debbie Holmes: Now, did you limit how many drugs that you examined, certain types, or what were they?
John Gray: No, we looked at any drugs that we could identify the facility where they were made. We looked at all drugs from injectables that you would get in a hospital to pills that you might buy at a pharmacy.
Debbie Holmes: Can you give me more specifics as to what kind of drugs these were?
John Gray: I mean, any drug on the market. I'm sorry, they were all drugs.
Debbie Holmes: All right. We're talking about cholesterol medicine. We're talking about hypertension medicine.
John Gray: Yeah, everything. And medications you get before and after a surgery, just any pharmaceutical drug at all. The entire market is what we looked at.
Debbie Holmes: Some of the findings show drastically worse outcomes from drugs made in India. Explain what they were.
John Gray: Well, we used an aggregate study where we were literally counting adverse events. I can just say that broadly there were more incidents of adverse events, but we did not go into deep detail as to specific adverse events. We simply counted the association of the drugs with an adverse event.
Debbie Holmes: You can't tell me then where or what exactly patients suffered from as a result?
John Gray: Yeah, there were thousands of adverse events in the study. Some of them were deaths. Some of them were hospitalizations. In each adverse event, there would be more information, but we did not. We simply took the classifications from the adverse events database and only included ones that were severe. So, again, hospitalization, death, disability, etc. And then counted the association of adverse events tied to the drugs. And again, there were higher. There were more with Indian drugs than U.S. drugs.
Debbie Holmes: Right now, then, is it that FDA does not go into India at all?
John Gray: Oh, no, they do. But (FDA) pre-announced their inspections. So, the Indian inspections are announced weeks or months in advance. And there have been two pilots, one in the 2010s and one currently going on, congressionally mandated, where the FDA has done unannounced inspections in India. So, it can be done. And early evidence from those pilots indicates that they're finding more issues when they go in unannounced than when they show up pre-announced. The balance is figuring out how to ensure that the cost pressures in the generic industry don't lead to kind of a race to the bottom, where the lowest cost manufacturer that maybe doesn't have quite as good compliance with regulations is the one always winning the business, because they're the cheapest.
The OSU study matched the drugs made in India to the same drugs made in the U.S. The study also found that the number of severe adverse events for generic drugs made in India was 54% higher than for equivalent matched generic drugs made in the United States. That was after accounting for a variety of other factors that could have impacted the results, including the volume of drugs sold.
Gray did not specify the types of generic drugs utilized in the study and how they were used.
