Details released by the agency last week reveal that, since at least 2006, Ranbaxy employees refrigerated samples that were supposed to be stored at room temperature to test their stability over time. In another instance, the plant reported stability test results for tablets of fluconazole, an antifungal drug, and ciprofloxacin, an antibiotic reserved for severe and life-threatening infections, as occurring at the required time intervals of months; but employees actually conducted all the tests on the same day or within a period of days. One audit of 15 applications approved for the US market found 1,676 errors, including errors in dates of analyses, packaging and stability test results. And during a 2008 inspection, plant records were found to contain the signatures or initials of Ranbaxy employees who were not present in the facility on the dates documented in the batch recordsFor some reason that does not sound surprising to me. There is a mad rush to plunge into the generics market once a lucrative drug patent expires, and companies may not engage in 100% quality control during this frenzy. Clearly, with great power comes great responsibility. Derek also has a post.
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The real costs of generics
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Our science education is clearly inadequate. There is, of course, lack of ethics in businesses, but this story also shows that science education does not teach good science. We are taught to get "correct" results when we do our practicals in school/college.Never in my years of studying science have I been told that it's extremely important to measure data accurately and to report it as it is. "Truth above all" is not taught as the very basis of science.
ReplyDeleteThat's a very good point. The focus as you say was never on actually understanding the system, taking the results as they are and interpreting them, including interpreting why they may be wrong. The focus was always on the getting the "right" answer, by hook or crook. Sadly, it also encouraged fraudulent practices among the students.
ReplyDeleteIt isn't clear to me that these are problems inherently unique to generics. Other drug companies making non-generics could have many of these problems as well. There might be more of these sorts of problems with the generics but that's not an obvious claim.
ReplyDeleteI give my lab instructors a lot of credit in the realm of "truth above all" as a lesson. They have always been crystal clear that they want our ACTUAL results, regardless of how crappy they are. Still, some people will fabricate results anyway... even when it won't hurt them grade-wise. The stupid ones get caught of course, but for the most part, instructors don't have time to look for fabricated data.
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