Cleveland Clinic Takes Unprecedented Steps in Planned Pfizer Trial

The Cleveland Clinic, reeling from revelations about conflicts of interest among its top brass, has adopted what lead researcher Dr. Steve Nissen is calling unprecedented financial controls on the upcoming $100 million trial testing Celebrex’ cardiovascular safety, which will be funded by Celebrex’ maker Pfizer.

Responding to an earlier post in GoozNews, Nissen wrote to say the Clinic will appoint an oversight committee for the trial that will be made up of academic physicians without any financial ties to companies that make Cox-2 painkillers. The trial will also follow the new Journal of the American Medical Association guidelines requiring trial physicians hire an independent data analyst (not one provided by the company). Nissen also plans to turn over the trial’s entire database to the National Institutes of Health, where the public will have access to the underlying data once the trial is completed.

“Given the problems with prior research for drugs in this class, I set the highest possible ethical standards for this trial,” he said. “I want to provide the public with an answer to these critical questions with the integrity you are seeking.”

Unfortunately, he confirmed the trial will not be designed to test whether Celebrex provides superior gastrointestinal protection compared to traditional pain pills like ibuprofen and naproxen, which are cheap and sold over the counter. Pfizer initially tried to make those claims, but was forced to drop them after it was revealed the company’s researchers did not include data in the journal article that would have shown the claim to be false.

According to Nissen, all patients will receive aspirin and omeprazole (Prilosec, the over-the-counter proton pump inhibitor that is the equivalent of prescription Nexium) to “level the playing field” for GI effects. “We chose to give everyone omeprazole because selective use would unblind the trial,” he said. “If omeprazole reduces GI events in the NSAID groups, there will be comparable GI safety. Keep in mind that these are secondary outcomes. The primary goal is CV outcomes.”

Fair enough. Once this trial is over, we’ll know if taking over-the-counter Prilosec along with over-the-counter ibuprofen is just as safe as taking prescription Celebrex (assuming the trial shows that Celebrex doesn’t raise one’s risk of heart attack). But how many people will want to do that when the co-pay on Celebrex will probably be less than the out-of-pocket expenses for two drugs bought over-the-counter?

I still say it would be nice to know if one gets any GI protection by taking Celebrex for pain (assuming it doesn’t harm heart health). Because if the answer is no, then there will no reason at all to write prescriptions for the drug.