Turn on your television at any point during the day or night and you will likely run across an ad for a prescription drug, along with a disclaimer about possible side effects. It seems only logical that those side effects are a possibility for anyone who takes the medicine, regardless of gender, race or age.
Unfortunately, that logic is wrong.
Studies of drugs and medical devices do not always report what effects these treatments may have on women, minorities or the elderly. Worse yet, those effects are not always investigated, as members of those populations are often underrepresented in trials -- despite the fact gender, race and age makes people more prone to certain diseases.
The American Heart Association and other groups helped bring this to Congress' attention. We worked closely with Sen. Debbie Stabenow, D-Mich., to include language in the Food and Drug Administration Safety and Innovation Act of 2012 requiring the agency to examine medical product applications for evidence on how they affected those groups, and how the information was evaluated and made public.
The report came out last summer and found some glaring problems. Like this one: While applications for new drugs generally reported research trial results by age, gender and race, sometimes applications were credited with including the information even when few women, minorities or elderly participated in the product's trials. Furthermore, the evidence -- or the lack of it -- never was considered by the agency during the drug approval process.
Congress required a second step, too. Once those disparities were identified, lawmakers required the FDA to come up with an "Action Plan." And that's where we are in the process now; on Tuesday, a public hearing will be held in Washington, D.C., to help guide those next steps.
I'm proud to say that the Chief Science Officer of the American Heart Association, Dr. Rose Marie Robertson, will be among those testifying. Dr. Robertson will stress one very important message: All patients (regardless of gender, race or age), deserve to know how safe and effective each medical product might be for them specifically - and so do healthcare professionals, whose job it is to match the right product with the right patient.
That kind of alignment just makes sense. There's also scientific evidence of drugs and devices that worked well for one population group yet badly in another.
The drug digoxin is a great example. Male heart-failure patients had no problem with it. In female heart-failure patients, it caused an increased rate of stroke. A "VAD" -- which stands for ventricular assist device, a piece of equipment used in the treatment of heart failure -- also is more likely to cause a stroke in women than men.
In a bit of a twist, detailed research may show that a drug is more helpful than initially thought. That's what happened with BiDil, a heart-failure medication initially intended for the general population. Studies didn't show convincing evidence that it improved patients' survival chances, but a later trial found it to be very effective among African-Americans. It became the first drug approved by the FDA for a single racial or ethnic group.
Statistics also frame what an obvious problem these discrepancies are.Gender
- While heart disease is the No. 1 killer of women in the United States -- claiming, in fact, more lives than all forms of cancer combined, and killing more women than men every year since 1984 -- only 35 percent of participants in cardiovascular research trials are women.
- Just 31 percent of these studies report their outcomes by gender.
- Among major cardiovascular clinical trials published between 1997 and 2010, minorities were frequently underrepresented. Only half of the trials even reported any racial information.
- While African-Americans account for 11 percent of all patients with coronary artery disease, they comprised only 3 percent of the research participants.
- More than 50 percent of all trials for coronary artery disease in the past decade did not enroll a single patient over 75 years of age.
- The geriatric population represented just 9 percent of all patients included in such trials.
There are still many unanswered questions about how and why cardiovascular diseases affect Americans differently. Learning the answers to these questions is necessary if we are to someday fulfill the promise of personalized medicine.