FDA approved doesn’t guarantee drugs are safe or effective

Trudy Lieberman Special to the Village News

What does the label "FDA-approved" really mean? Most people probably think it assures that a drug you take is safe and effective for the condition you have. It seems to say a drug has passed muster with the drug safety experts in Washington so it’s okay to use it, right? Well, not quite.

An investigation by the Milwaukee Journal Sentinel has just concluded FDA approval is no guarantee a drug is safe and effective, and the paper’s investigation of diabetes drugs, should make every user of prescription drugs think twice about medications their doctors prescribe.

In December the Journal Sentinel and its partner MedPage Today revealed that more than 3,000 deaths and some 20,000 hospitalizations have been linked to diabetes drugs in the last decade. The drugs include some you’ve probably seen advertised like Januvia, Byetta, and Victoza.

Reporters found none of the 30 new diabetes drugs have been proven effective in reducing key complications of the disease like heart attacks, strokes, or blindness.

Diabetes drugs as well as others win the seal of approval based on what’s called a surrogate measure, a proxy or a stand-in measure for the eventual clinic outcome everyone wants like saving lives. A proxy measure for diabetes drugs might show that it lowers blood sugar that might eventually ward off serious complications. If it can show that, it’s usually approved, and the big advertising push begins. It doesn’t have to show that it actually saves lives or prevents blindness.

The reasons for these surrogate measures go back two decades to changes in the FDA rules pushed by politicians, drug companies and patient advocacy groups, which are often funded by drug makers.

They wanted speed in getting drugs to market and opening new paths for treatment and for drug company profits. Diabetes drugs are big business. Sales reached $23 billion in 2013. Journal Sentinel reporters put that number in perspective. It’s larger than the combined revenue of the National Football League, Major League Baseball, and the National Basketball Association.

Still, there were signs back then that drugs were reaching the market without adequate testing. "Speed kills," a policy researcher at George Washington University told me at the time. The Journal Sentinel investigation shows it still does. Certainly many drugs make people better and save lives, but many others are being marketed for more questionable reasons. Prescribing diabetes drugs for "pre diabetics" who may or may not get the disease is a case in point.

I asked Mayo Clinic diabetes expert Dr. Victor Montori about this. "The trend to offer drugs to patients to delay a diagnosis of diabetes without making them healthier is a significant problem," he said. "Almost half of those included in the definition of patients with pre-diabetes won’t develop the disease in 10 years."

Still, with so much money sloshing around in this business –drug companies often offer dinners, gifts and speaking fees to reward doctors who prescribe their drugs – it’s hard to know if you’re getting the best medical advice. [www.propublica.org/series/dollars-for-docs]

What’s a patient to do? Some of these drugs have what are called "black box" warnings meaning a drug poses significant, serious or life threatening risks. Montori says people should ask their doctors if they really need a particular drug and if there are alternatives. I would add don’t brush off the side effects. They are real for lots of people, as the Journal Sentinel showed.

Larry Sasich, a pharmacist, is the co-founder of www.patientdrugnews.com/. Patient Drug News once worked for Public Citizen, the medical advocacy group in Washington, and has represented consumers on FDA advisory committees.

He had another suggestion: Check the website of DailyMed, http://dailymed.nlm.nih.gov/dailymed/index.cfm, operated by the National Library of Medicine and the FDA.

It shows the current product labels for drugs marketed in the U.S. along with medication guides for those drugs that the agency says have significant public health concerns. Sasich said more than 200 drugs are now required to have such guides. Januvia is one of them. In a section called "What’s the most important information I should know," the guide warns, "Serious side effects can happen in people taking Januvia, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death."

These guides are supposed to be distributed with every new and refilled prescription, but it’s not clear pharmacies are doing that.

The takeaway is obvious: When you’re offered a new medicine, especially one with not much of a track record, ask as many questions and check as many independent sources as you can before risking your life. Ultimately you are the one who must decide if the potential benefits outweigh potential harms.

Trudy Lieberman, a journalist for more than 40 years, is also a fellow at the Center for Advancing Health and has had a long career at Consumer Reports specializing in insurance, health care and health care financing. She was also the director of the Center for Consumer Health Choices at Consumers Union and now writes for Rural Health News Service.