At the Meeting of the FDA Risk Communication Advisory Committee
February 25, 2010
I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies. We then translate that complicated information into plain language so that patients, consumers, media, and policy makers will understand it.
We do not accept contributions from companies that make medical products.
In addition, I am a fellow at the University of Pennsylvania Center for Bioethics. Previously, I was on the faculty at Yale and Vassar and conducted research at Harvard, and I was trained in epidemiology at Yale Medical School. I tell you this because my perspective is as a scientist but my work consists of explaining science to people who don’t have the training I have. In fact, when we train interns and new staff, the hardest part is getting very smart, well-educated people to write so that the general public understands the health information they need.
The FDA materials we were asked to review look like homework assignments. They seem as if they were written by people with graduate degrees for people with graduate degrees-or at least smart college grads. But many Americans don’t go to college, and even high school grads often don’t read at the 12th grade level. A lot of people don’t like to read at all, or don’t read well, and you need to make sure they can understand what they need to know. That’s why it is important to communicate risk information at the 5th grade or 8th grade level instead.
Even educated people don’t want to read long, complicated materials-except possibly the most highly motivated people, and even they want to get the meat of the matter, not the extraneous information. And, also remember that most medications in this country are taken by the elderly, and even those who are highly educated may not be able to read or concentrate as well as they did when they were younger.
Graphics are important, as you know. When the companies you regulate want to get people’s attention, they use TV ads and attractive graphics on print ads. But whether or not you use great graphics, you can make the materials easier to read by using bold fonts, different size fonts, and more white space. You can make the materials look more inviting, and less like work.
Overall, the FDA communications you provided to us use:
- sentences that are too long,
- words that are too technical or difficult for many readers, and
- include too many unnecessary details
For example, it isn’t really necessary to include the date when a drug was approved by the FDA, because it doesn’t matter to the patient whether it was November 2004, January 2004, or 2006. If you think that there are details that might be important to some patients, include it last or in a link.
Here’s a booklet for breast cancer patients that we wrote with the National Cancer Institute and NIH. http://www.center4research.org/pdf/booklet04bc.pdf It is geared to an 8th grade reading level. Compare that to the materials that the FDA is using, such as the patient booklet that the FDA requires for women who are getting breast implants to help them understand the risks.. That booklet is about 45 pages long, 8.5 x 11″, unattractive and uninviting. You have to get through half of it to get to some of the crucial risk information. It’s so long that most women are not going to get past the first page or two. I think we can all agree that breast implants are not more important or more complicated than breast cancer. So why the difference between the two booklets? There is a clear disconnect between what NIH is giving patients and what FDA is giving them, and the NIH is usually doing a better job. I agree with the panel member who pointed out that the Office of Women’s Health at the FDA is also doing a better job at providing user-friendly information to patients and consumers.
The risk information for LASIK patients is similarly overly long and technical. It has lots of great information but many patients are just not going to get that far into the booklet. If we want them to get that information, the materials need to be shortened and made less technical.
I want to take a few minutes to make a few specific comments about the examples you provided for this meeting. I will focus on the ones for patients.
I agree with what was said about the titles being too long. “FDA Drug Safety Communication” should not be the beginning of the title. Shorten that to “FDA Drug Safety Alert,” and make that a separate line, perhaps a logo on the top of the page.
The title “Risk of Progressive Multifocal Leukoencephalopathy (PML) with the Use of Tysabri (natalizumab)” is too long and too hard to read. Why not call it “Risks of Tysabri (natalizumab)”? That will get and keep people’s attention so they will want to read it, if they are on the drug or prescribed the drug.
FDA also needs to avoid phrases like “this medication has been associated with this risk.” Most people don’t know what “has been associated” means. I understand you can’t or might not want to say “causes this risk,” but you need a verb that has meaning to people. Perhaps “increases the risk of” or “may cause in some people.”
Regarding the flu vaccine information you provided, why not just call it a “flu vaccine” not an “inactivated Influenza vaccine” or “attenuated influenza vaccine” or a “monovalent vaccine.” People say “flu” and so should FDA, and most people will not understand or need to know exactly what kind of vaccine it is.
On the vaccine fact sheet that was apparently meant to reassure patients, here’s a typical sentence “Aluminum salts are incorporated into some vaccine formulations as an adjuvant to enhance the immune response in the vaccinated individual.” Who talks like that? How about: “Aluminum salts are in some vaccines to make them more effective.”
That makes the point in a way that is much easier to understand.
In your previous discussion, there were some concerns about making sure patients know that there is a risk of death, when there is one, but also putting that in the context of other risks in their lives. I think that numbers, such as “there have been 13 deaths reported in the last 12 years” is not always helpful, because the number of reported deaths may not represent the deaths caused by the product-it could be higher or lower. And, when people ask their doctors about those numbers, there seems to be a tendency to down play them, especially if the physician hasn’t had a patient who died from that product. And, for some people, x number of deaths might seem very high and for another it might seem very low. So, it’s difficult to know how to present that information.
However, when there is a serious risk from a medical product, whether that risk is death or serious harm, I don’t think comparing that to other risks-getting hit by lightening or dying in a car accident, for example-is helpful for most people. Unfortunately, these risks are cumulative. All of us who use cars run the risk of having a car accident, for example, and we can lower that risk by driving more carefully, but that risk is always going to be there whether or not we use a medical product with additional risks. It seems to me the comparison of risk should be to other medical products with the same benefits, or to no treatment at all. That’s the additional risk posed by that particular medical product, and patients should know if the risk is rare, very rare, or as high as 1 in 100, or 1 out of 10, or whatever it is.
Thank you for the opportunity to share our thoughts with this distinguished panel, and the FDA staff who are working hard to improve FDA’s ability to inform patients and consumers.