American drug researchers have hit some amazing home runs. Among them: brain-sparing stroke drugs, heart-saving clot dissolvers, migraine-stopping triptans and cholesterol-controlling statins (which both lower your lousy LDL and raise your healthy HDL cholesterol). But like all big businesses, from giant hedge funds to professional cycling, Big Pharma can sometimes have a dark side, too.
An international watchdog group recently warned that 60 percent of safety research on new drugs in the United States is never published, in part because drug makers have no desire to highlight problems. Could hidden research hurt you? You bet.
Suppose you have diabetes and your blood sugar has been fairly well-controlled, but it could be better. A year ago, in an attempt to improve it, your doctor recommended switching to the newer drug rosiglitazone (Avandia) — which recently was found to raise heart attack risk by 40 percent. A team led by Cleveland Clinic cardiovascular sleuth Dr. Steven Nissen discovered the data on a hidden company Web site. The Food and Drug Administration, Nissen and others claim that this danger was hidden for more than a decade.
An all-too-similar problem happened with the so-called super-aspirin rofecoxib (Vioxx), a heavily promoted pain reliever that was pulled from the market in 2004, also due to increased heart attack risk that drug makers also allegedly hid. Once again, Nissen spotted the problem.
Big, hairy clues about seemingly good drugs that turn out to have bad sides often are locked away in what Germany’s crusading Institute for Quality and Efficiency in Health Care calls a “secret archive” that not only you but also your doctor cannot read.
What can you do to protect yourself from this, short of moving to Cleveland and becoming Nissen’s patient? Actually, quite a lot. Here’s what:
If you’re given a new prescription, ask if it’s for a new drug. When your doc recommends a relatively new medication, ask (politely) if there’s an older drug that will do the same job. Why? New drugs are usually approved based on studies involving a few thousand people. But sometimes side effects or interactions — even big ones — only show up after hundreds of thousands of people have started taking them.
That’s why drug safety experts recommend avoiding medications until they’ve been on the market for two or three years. And that’s why the Institute of Medicine wants new drugs to be marked with a special symbol. You’re right if you think we like this idea. The longer a drug’s been around, the fewer unpleasant surprises you and we are likely to have.
Bonus: Older drugs are often less expensive.
We know it’s not always that simple. If you have a serious condition that’s not improving, or you have limited treatment options to start with and they’re not working, it’s likely worth taking a chance on a newer drug. If you do …
Report odd reactions to your doctor. Right away. Don’t assume it’s “just you.” You may need to switch drugs or reduce your dose for your own safety. You and your doc also should report bad reactions (what are called “adverse events”) to the FDA. Alerts from physicians and patients often are the first signs of trouble with a new drug, yet experts say just 1 percent to 10 percent of all adverse drug reactions ever get reported. It’s easy to do this online. While we try not to give long addresses like this, this one’s important: fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm.
If you wind up taking a new drug, check for safety alerts online. The FDA posts information about newfound medication risks at fda.gov/Safety/ MedWatch/default.htm.
Don’t panic if bad news breaks. Suppose you’ve been taking a medication for a while that suddenly develops safety problems. Don’t stop taking it cold turkey. That could cause other problems, including withdrawal issues. Call your doc and make a plan.
Put pressure on Washington. New-drug scrutiny is improving, but it needs to get even better. The FDA is considering new ways to make more information public about the safety of drugs, medical devices, foods and cosmetics. How can you help? It really does work to do the usual: E-mail, write or tweet your congressional representatives. Tell ’em you’re in favor of “transparency” in drug research. More facts keep everybody safer. Including YOU.
The YOU Docs, Mike Roizen and Mehmet Oz, are authors of “YOU: Being Beautiful — The Owner’s Manual to Inner and Outer Beauty.” To submit questions and find ways to grow younger and healthier, go to realage.com, the docs’ online home.
