The task of protecting the public falls on the shoulders of the FDA. It’s responsible both for checking through the science of the testing process before licensing the drug, and for monitoring the drug’s performance once approved. The drug manufacturers complain about the cost of compliance. They prefer the lowest possible level of regulation, leaving it to the marketplace to decide whether the drug is safe and effective. But there’s good evidence that capitalism does not work well with drugs. To understand the problem, take the recent recall of cars that apparently refused to stop when people put their foot on the brakes. Even after all the excitement of Toyota’s CEO coming to Washington to apologize, we are no closer to understanding whether this was driver error or a design defect.
One of the difficulties in regulating any market is deciding whether to intervene. The National Highway Traffic Safety Administration had received 124 reports of braking problems with four crashes. It did not think this justified a recall. Now switch back to drugs. The FDA has a postmarketing monitoring program. Hospitals and doctors should report any serious adverse side effects. But there’s no law requiring hospitals or doctors to file these reports. And, even if they do, when do these reports signal a real problem? There are no agreed standards to decide when a report should be sent, nor as to the way in which the report should be written. Some might send a single sentence. Others might write pages about the patient, giving medical history and details of the treatment. Unless you go and investigate every report, there’s no way of getting consistency of view and establishing whether there’s a pattern.
Last year, there were 113 million prescriptions written for proton pump inhibitors (PPIs). This is on top of all the over-the-counter antacids and all the sales made through online pharmacies. There are millions of people who suffer heartburn and more serious problems caused by the release of stomach acid. The FDA has recently announced it proposes to change the labeling on PPIs. There have been no reports from the monitoring program, but independent research suggests there may be a link between using a PPI and wrist, spine and hip fractures in older women. After the menopause, all women start to lose bone density so any fall may cause a fracture. However, the research suggests bones may be more brittle if women take a PPI for more than one year.
Note the “may”. At present no one knows whether PPIs increase the risk. But, if you are postmenopausal and regularly take Nexium, you should follow news of the FDA’s investigation. It’s entirely possible the further research will show no cause and effect. It may just be a coincidence that the particular sample of people with fractures happened to be taking a PPI. Until we have better information, there’s no reason to stop taking Nexium or any other PPI. Unless, as a precaution, you ask you doctor for a check-up if you have been taking this class of drug for more than a year.
