Some Post-Approval Studies Need a Long Time: Opinion Post
While post-marketing drug studies should be completed as quickly as possible, there are some studies that simply take a long time to get right. That’s the view of Forbes healthcare contributor John LaMattina in an online post. He reports that most post-marketing studies are completed in four years, but many take considerably longer.
“These type of delays reflect badly on both FDA and drug companies,” he writes, “the former because it seems that the agency is not doing its job and the latter because it appears that companies are intentionally shirking their responsibilities to avoid finding negative data on their drug. By acting this way, a company can maximize its profits at the perceived risks of patient safety.”
LaMattina uses the Pfizer Celebrex (celecoxib) post-approval study to make his point that some studies legitimately require a long time. He reports that the study was first recommended 2/2004 and the first patient wasn’t screened until 10/2006. Rather than Pfizer dragging its feet, he writes, the study design was time consuming as it involved many stakeholders and getting all of them to agree was challenging. Finally, the PRECISION study was designed to look at 24,081 patients, with 8,072 on Celebrex, 7,969 on naproxen, and 8.040 on ibuprofen. To get 24,081 patients entered into the trial, 31,857 had to be screened. Ultimately there were 926 study centers in 13 countries and it took eight years to enroll all the patients and then 1.5 years of patient follow-up. The results were published in the New England Journal of Medicine 11/2016, more than 12 years after FDA requested the study.
“Yes, this study took a long time and a cynic could say that Pfizer dragged PRECISION out to guard against generating negative data,” LaMattina concludes. “However, this study cost anywhere from $500 million to $1 billion to run because of its size and duration. By the time the results were in hand, the Pfizer patent for Celebrex was about to expire. The unfortunate length of the study proved to be a missed opportunity for Pfizer. Billions of dollars in additional sales could have been realized had the PRECISION results been available in 2010….Certainly, we should all be critical of companies that are negligent in complying with post-marketing commitments required by FDA. However, such studies can be complicated and difficult to complete rapidly. The Celebrex PRECISION study is a great example of that.”