Patricia Slingo has trouble walking up stairs. She gets winded easily and sits down a lot.
She takes a handful of pills to keep her heart functioning, and when she looks in the mirror, the first thing she sees is a big pink scar on her breastbone, the result of bypass surgery.
She believes her heart problems are due to Vioxx, a drug she took to ease her arthritis. She doesn’t know for sure. But she does know that she didn’t have heart problems before she took Vioxx, and she continued taking it until shortly before the drug was pulled from the market for increasing heart attack risk, a risk she never knew about.
“I can’t say for certain Vioxx caused my heart problems,” says Slingo, who also had angioplasty and stents placed in her heart. “But I wish I would have known what the drug maker knew.”
Unfortunately, Patricia’s story isn’t unique. Consumers Union has heard from scores of consumers who have suffered major health problems, or lost a loved one, from deadly drug side effects.
Millions of Americans have taken prescription drugs trusting that the Food and Drug Administration, and the drug company, were telling them about all the potential safety risks, only to learn later that the agency or the company or both had kept safety risk information from the public.
That secrecy has to stop. Next week, the U.S. House is slated to vote on the most significant drug safety reforms in 45 years. If the measure passes and if the House and Senate reconcile their versions and send a strong bill to the president, consumers might start having faith again that the FDA is putting their interests first when it comes to drug safety. But there is still work to be done.
Included in the legislation is a requirement that drug companies publicly register their clinical trials and make those results public. These studies are conducted on human volunteers to determine if the medication is safe and effective and are where unwanted side effects and safety problems often become evident. Right now, drug makers release the positive news from these studies, but they can downplay or hide the negative because they are not required to make results public.
Keeping these studies from doctors, researchers and patients is unethical at best and dangerous at worst. In the case of Vioxx, the drug’s manufacturer, Merck, and the FDA had known of safety risks since 2000, when the first study raised concerns about heart attack and stroke risk. Nearly five years and more than $500 million in advertising dollars later, the drug was finally removed from the market after being linked to an estimated 139,000 heart attacks and strokes.
The House bill would require within a year the creation of a public, searchable Web site listing clinical trials and their results. A Senate version of the legislation passed earlier this year calls for a study on how to create such a registry and gives the FDA two and a half years to complete the study and implement a registry. Exactly what the registry would require under the Senate bill is uncertain.
It’s vital that the House approach on a clinical trial results registry remains in the bill that goes to the president. Prescription drugs can provide important health benefits, but we can’t afford to wait years before we know about all their potential safety risks.
Anyone who has ever taken a pill and counted on it to be safe and effective should let Congress know that it’s time to end the secrecy. Consumers such as Patricia Slingo should know about all the benefits and risks of a drug, so they aren’t left to wonder if the pill they are about to swallow will do them more harm than good.